Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-28 @ 8:23 PM
Study NCT ID:
NCT00366457
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2006-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'LBLASZKOWSKY@mgh.harvard.edu', 'phone': '6172191230', 'title': 'Lawrence S. Blaszkowsky, MD', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Gemcitabine, Bevacizumab and Erlotinib', 'description': 'single-arm, no masking\n\nBevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.\n\nErlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.\n\nGemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.', 'otherNumAtRisk': 30, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 102, 'numAffected': 25}], 'organSystem': 'General disorders'}, {'term': 'Leukocytes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 84, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 73, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Rash: acne/acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 91, 'numAffected': 23}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 71, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 80, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'ALT- SGPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 76, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 78, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Neutrophils', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 67, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'AST- SGOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 77, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Abdomen - pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 47, 'numAffected': 20}], 'organSystem': 'General disorders'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 48, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 34, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 27, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Diarrhea w/o prior colostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 61, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 35, 'numAffected': 15}], 'organSystem': 'General disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 25, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Rigors/chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'General disorders'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 30, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 25, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Nose- hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 19, 'numAffected': 11}], 'organSystem': 'General disorders'}, {'term': 'Fever w/o neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'General disorders'}, {'term': 'Bilirubin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 19, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 24, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 17, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 15, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'General disorders'}, {'term': 'Muco/stomatitis (symptom) oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pruritus/itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Head/headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 13, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Muco/stomatitis by exam- oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Extremity-limb- pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 23, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 22, 'numAffected': 5}], 'organSystem': 'Cardiac disorders'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 16, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 13, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 5}], 'organSystem': 'Nervous system disorders'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Edema limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Voice changes/dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Bicarbonate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Muscle- pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'GI-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Back- pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders'}, {'term': 'Infection Gr0-2 neut- upper airway', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Chest/thoracic pain NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Neurologic-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Immune system disorders'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Pain-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Pulmonary/Upper Respiratory-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Throat/pharynx/larynx- pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Nonneuropathic generalized weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Ocular-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders'}, {'term': 'Pain NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Taste disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Distention/bloating- abdominal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Neuropathy-sensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Flu-like syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Hiccoughs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Joint- pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Musculoskeletal/soft tissue-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Rectum- hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Rectum- pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Renal/GU-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Pumonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Death from disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Endocrine disorders'}, {'term': 'Death from infection or sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Brain Infarct', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Tumor Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine, Bevacizumab and Erlotinib', 'description': 'single-arm, no masking\n\nBevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.\n\nErlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.\n\nGemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '5.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'all patients will be followed for a minimum of 4 months', 'description': 'Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death.\n\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who started treatment'}, {'type': 'SECONDARY', 'title': 'Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine, Bevacizumab and Erlotinib', 'description': 'single-arm, no masking\n\nBevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.\n\nErlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.\n\nGemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.'}], 'classes': [{'categories': [{'title': 'Partial Response', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Progressive Disease', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Stable Disease', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'after at least one 28-day cycle of treatment', 'description': 'Response rate using RECIST criteria and latest time point available. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants with response data available'}, {'type': 'SECONDARY', 'title': 'Toxicity Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine, Bevacizumab and Erlotinib', 'description': 'single-arm, no masking\n\nBevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.\n\nErlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.\n\nGemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.'}], 'classes': [{'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'ALT-SGPT', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Rash: acne/acneiform', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Thrombosis/thrombus/embolism', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Anorexia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'AST - SGOT', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Nonneuropathic generalized weakness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Upper GI-hemorrhage NOS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Vascular access-Thrombosis/embolism', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Vessel injury - artery - Other NOS', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Weight loss', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during and after first 28-day cycle of treatment', 'description': 'Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who started treatment'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcitabine, Bevacizumab and Erlotinib', 'description': 'single-arm, no masking\n\nBevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.\n\nErlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.\n\nGemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '11.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 years', 'description': 'overall survival (OS) = time from study entry until death from any cause', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who started treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gemcitabine, Bevacizumab and Erlotinib', 'description': 'single-arm, no masking\n\nBevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.\n\nErlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.\n\nGemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'never began study therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Gemcitabine, Bevacizumab and Erlotinib', 'description': 'single-arm, no masking\n\nBevacizumab: Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.\n\nErlotinib: Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.\n\nGemcitabine: Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'spread': '9.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'participants who started treatment'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2006-08-17', 'resultsFirstSubmitDate': '2017-02-14', 'studyFirstSubmitQcDate': '2006-08-17', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-14', 'studyFirstPostDateStruct': {'date': '2006-08-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Tumor Progression', 'timeFrame': 'all patients will be followed for a minimum of 4 months', 'description': 'Time to tumor progression (TTP) = time from date of initial treatment to first objective documentation of progressive disease or death; patients who die without a reported prior progression will be considered to have progressed on the day of their death.\n\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.'}], 'secondaryOutcomes': [{'measure': 'Response Rate', 'timeFrame': 'after at least one 28-day cycle of treatment', 'description': 'Response rate using RECIST criteria and latest time point available. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.'}, {'measure': 'Toxicity Profile', 'timeFrame': 'during and after first 28-day cycle of treatment', 'description': 'Grade 3-4 treatment-related toxicities (treatment-related = possible, probable, or definite) Grading system: 1= mild, 2 = moderate, 3 = severe, 4 = life-threatening'}, {'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': 'overall survival (OS) = time from study entry until death from any cause'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pancreatic Cancer', 'Adenocarcinoma of the Pancreas']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to learn whether or not the combination of gemcitabine, bevacizumab and erlotinib works in treating patients with advanced or metastatic pancreatic cancer. Bevacizumab is a new anti-cancer drug. It is an antibody that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors. It is approved by the FDA for the treatment of colorectal cancer but is still considered investigational for treating pancreatic cancer.', 'detailedDescription': '* Participants will receive study treatment as an outpatient. The study treatment will be given in time periods called cycles. Each treatment cycle will be 28 days.\n* Gemcitabine will be given intravenously on days 1, 8, and 15 (once per week for the first three weeks) of the treatment cycle.\n* Bevacizumab will be given intravenously on days 1 and 15 (once every 2 weeks) of the treatment cycle.\n* Erlotinib will be taken orally every day of the treatment cycle.\n* Participants will see the doctor or nurse practitioner every week for the first 28 days of treatment. During all of the following cycles, they will see the doctor or nurse practitioner on day 1 and day 15 of each cycle.\n* Each 4-week cycle can be repeated until the participant or the doctor decided that they should be removed from the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously untreated patients with unresectable or metastatic adenocarcinoma of the pancreas\n* ECOG Performance Status 0-2\n* 18 years of age or older\n* Radiographically measurable disease\n* Expected survival of at least 4 months\n* Creatinine of \\</= 2.0\n* Adequate hepatic function\n* Adequate hematopoietic function\n* Use of effective means of contraception in subjects of child-bearing potential\n\nExclusion Criteria:\n\n* Warfarin anticoagulation\n* Prior treatment with a tyrosine kinase inhibitor, EGFR inhibitor, or VEGF inhibitor\n* Coexistent malignant disease\n* Current or recent (within 4 weeks) participation in a clinical trial\n* Pregnancy\n* Documented invasion of adjacent organs or major blood vessels\n* Blood pressure of \\> 150/100mmHg\n* Unstable angina\n* NYHA Grade II or greater congestive heart failure\n* History of myocardial infarction or stroke within 6 months\n* Clinically significant peripheral vascular disease\n* Evidence of bleeding diathesis of coagulopathy\n* Presence of CNS or brain metastases\n* Major surgical procedure, open biopsy, or significant traumatic event within 28 days\n* Minor surgical procedures, fine needle aspirations or core biopsies within 7 days\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months\n* Serious non-healing wound, ulcer or bone fracture'}, 'identificationModule': {'nctId': 'NCT00366457', 'briefTitle': 'Gemcitabine, Bevacizumab and Erlotinib in Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Phase II Study of Gemcitabine, Bevacizumab and Erlotinib in Locally Advanced and Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': '05-234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Gemcitabine, Bevacizumab and Erlotinib', 'description': 'single-arm, no masking', 'interventionNames': ['Drug: Bevacizumab', 'Drug: Erlotinib', 'Drug: Gemcitabine']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['rhuMAb VEGF'], 'description': 'Given intravenously on days 1 and 25 of every 28-day cycle (one every 2 weeks). Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.', 'armGroupLabels': ['Gemcitabine, Bevacizumab and Erlotinib']}, {'name': 'Erlotinib', 'type': 'DRUG', 'otherNames': ['Tarceva'], 'description': 'Taken orally every day. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.', 'armGroupLabels': ['Gemcitabine, Bevacizumab and Erlotinib']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemzar'], 'description': 'Given intravenously on days 1, 8 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as there is no disease progression or serious side effects.', 'armGroupLabels': ['Gemcitabine, Bevacizumab and Erlotinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Lawrence S. Blaszkowsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Physician', 'investigatorFullName': 'Lawrence S. Blaszkowsky, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}