Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-26 @ 8:39 PM
Study NCT ID:
NCT00998166
Status:
TERMINATED
Last Update Posted:
2024-07-30
First Post:
2009-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Cisplatin + Pemetrexed + Avastin as First-Line Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mbs5@cumc.columbia.edu', 'phone': '212-305-8230', 'title': 'Mark Stoopler, MD', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pemetrexed, Cisplatin, Bevacizumab', 'description': 'Chemotherapy infusion on Day 1 of a 3-week cycle\n\nPemetrexed: 1. Pre-hydration for 1-1/2 hours at 250 ml/hour 2. Pemetrexed 500 mg/m2 IV over 10 minutes 3. Return to hydration for 30 minutes at 250 ml/hour\n\nCisplatin: 4. Cisplatin 75mg/m2 IV over 60-120 minutes\n\nBevacizumab: 5. Bevacizumab 15mg/kg IV over 90 minutes', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Elevated Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Flank Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Thrombotic Microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Allergic Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}], 'organSystem': 'Cardiac disorders'}, {'term': 'Hoarseness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Epigastric Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Increased Blood Urea Nitrogen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Left calf cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Vasovagal Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Taste Alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Periorbital edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Increased Nasal Mucus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Runny Nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Skin Tears', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevalence of Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemetrexed, Cisplatin, Bevacizumab', 'description': 'Chemotherapy infusion on Day 1 of a 3-week cycle\n\nPemetrexed: 1. Pre-hydration for 1-1/2 hours at 250 ml/hour 2. Pemetrexed 500 mg/m2 IV over 10 minutes 3. Return to hydration for 30 minutes at 250 ml/hour\n\nCisplatin: 4. Cisplatin 75mg/m2 IV over 60-120 minutes\n\nBevacizumab: 5. Bevacizumab 15mg/kg IV over 90 minutes'}], 'timeFrame': 'Up to 1 year', 'description': 'PFS defined as the time from the date of the first dose to the first date of disease progression or death.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was NOT collected due to early study termination and therefore not analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pemetrexed, Cisplatin, Bevacizumab', 'description': 'Chemotherapy infusion on Day 1 of a 3-week cycle\n\nPemetrexed: 1. Pre-hydration for 1-1/2 hours at 250 ml/hour 2. Pemetrexed 500 mg/m2 IV over 10 minutes 3. Return to hydration for 30 minutes at 250 ml/hour\n\nCisplatin: 4. Cisplatin 75mg/m2 IV over 60-120 minutes\n\nBevacizumab: 5. Bevacizumab 15mg/kg IV over 90 minutes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Early Study Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}], 'preAssignmentDetails': 'Twelve participants enrolled (signed a consent form). Two participants were screen failures and data was not collected for an additional two participants as the study terminated early, resulting in 8 participants starting the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pemetrexed, Cisplatin, Bevacizumab', 'description': 'Chemotherapy infusion on Day 1 of a 3-week cycle\n\nPemetrexed: 1. Pre-hydration for 1-1/2 hours at 250 ml/hour 2. Pemetrexed 500 mg/m2 IV over 10 minutes 3. Return to hydration for 30 minutes at 250 ml/hour\n\nCisplatin: 4. Cisplatin 75mg/m2 IV over 60-120 minutes\n\nBevacizumab: 5. Bevacizumab 15mg/kg IV over 90 minutes'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Poor enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2009-10-14', 'resultsFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2009-10-16', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-29', 'studyFirstPostDateStruct': {'date': '2009-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Progression Free Survival (PFS)', 'timeFrame': 'Up to 1 year', 'description': 'PFS defined as the time from the date of the first dose to the first date of disease progression or death.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSCLC'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'In the past, patients with advanced lung cancer who were inoperable underwent chemotherapy with one or more chemotherapeutic agents. More recently, novel new agents targeting specific enzymes or pathways responsible for cell division have been developed and clinicians have begun to utilize various combinations of these drugs with standard chemotherapeutic agents for the treatment of NSCLC. Some of these approaches have demonstrated a small but significant increase in survival among patients with advanced disease. Because a recently completed Phase 3 study of bevacizumab + Taxol/Carboplatin in first line NSCLC therapy demonstrated a 23% improvement in median survival, it would be appealing to see if a regimen of bevacizumab/ cisplatin/Alimta would also demonstrate a similar, or perhaps better, response rate.', 'detailedDescription': 'The majority of patients with NSCLC present with inoperable locally advanced or metastatic disease for which no curative therapy is available. For these patients, platinum based doublet combination regimens have become standard of care due to increased survival rates over platinum therapy alone.\n\nIn order to try to improve on the overall survival, clinicians have attempted to add a third cytotoxic agent to their standard regimen(s). Although this approach demonstrated an improved objective response, no additional benefit was noted in overall survival.\n\nRecent development and approval of new targeted chemotherapies during the past 10 years has prompted clinical trials to test the efficacy of newly FDA approved agents such as gefitinib, erlotinib, and bevacizumab in advanced NSCLC.\n\nAlthough gefitinib and erlotinib have both demonstrated clinical activity in refractory NSCLC, neither agent improved clinical outcome when added to standard 1st line platinum based chemotherapy. In contrast, a recently completed randomized Phase 3 trial investigating the addition of bevacizumab to 1st line paclitaxel plus carboplatin chemotherapy reported a 23% improvement in the median overall survival for the paclitaxel/carboplatin plus bevacizumab treatment arm (12.5m vs. 10.2m; p=0.007). It is therefore appealing to study a cisplatin combination with bevacizumab to determine if there is any additive benefit. Pemetrexed is an ideal agent to use in combination with cisplatin since it is well tolerated and efficacy is comparable to other cisplatin combinations. Patients will receive a maximum of 6 cycles. Those who complete 1 cycle will be evaluated for toxicity; more than 1 cycle, response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have stage IIIB (malignant pleural or pericardial effusion) or stage IV disease.\n* Be chemotherapy naïve.\n* Have measurable disease by RECIST, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as \\>20 mm with conventional techniques or \\>10 mm with spiral CT scan; the longest diameter is to be recorded.\n* Are 18 years of age or older.\n* Have a life expectancy greater than 3 months.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Are able to provide written informed consent in accordance with all applicable regulations and follow the study procedures. Patients must be capable of understanding the investigational nature, potential risks and benefits of the study.\n* The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Alimta and the ability to take folic acid, Vitamin B12 and dexamethasone according to protocol.\n\nExclusion Criteria:\n\n* Have had prior chemotherapy (or an epidermal growth factor receptor (EGFR TKI) for treatment of advanced disease\n* Intrathoracic lung carcinoma of squamous cell histology\n* History of hemoptysis (bright red blood of 1/2 teaspoon or more per episode) within 1 month prior to study enrollment.\n* Current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin).\n* Current or recent (within 10 days of enrollment) use of aspirin (\\>325 mg/day) or chronic use of other NSAIDs.\n* Cardiovascular concerns.\n* Have had radiation therapy within 2 weeks prior to enrollment.\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study.\n* Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0.\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1.\n* Serious, non-healing wound, ulcer, or bone fracture.\n* Have inadequate organ function at the Screening visit.\n* Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).\n* Have uncontrolled active systemic infection requiring treatment.\n* Have had treatment for a cancer other than NSCLC within 5 years prior to enrollment, with the exception of basal cell carcinoma or cervical cancer in situ.\n* Have known human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status or known active hepatitis C infection. Patients assessed by the investigator to be at risk for HIV, hepatitis B or C infection should be tested in accordance with local regulations.\n* Are a pregnant or breast-feeding female. Confirmation that the patient is not pregnant must be established by a negative serum Beta-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during the Screening Period. Pregnancy testing is not required for post-menopausal or surgically sterilized women.\n* Are unwilling to employ adequate means of contraception (condoms, diaphragm, birth control pills, injections, intrauterine device, or abstinence).\n* Are currently receiving or have previously received an investigational agent for any reason within 4 weeks of enrollment.\n* Presence of third space fluid which cannot be controlled by drainage.\n* Inability to comply with study and/or follow-up procedures.\n* Prior history of hypertensive crisis or hypertensive encephalopathy.\n* History of stroke or transient ischemic attack within 6 months prior to Day 1.'}, 'identificationModule': {'nctId': 'NCT00998166', 'briefTitle': 'A Study of Cisplatin + Pemetrexed + Avastin as First-Line Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'A Phase 2 Study of Cisplatin + Pemetrexed + Avastin as First-Line Therapy in Patients With Advanced Non-Squamous, Non-Small Cell Lung Carcinoma', 'orgStudyIdInfo': {'id': 'AAAB9652'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pemetrexed, Cisplatin, Bevacizumab', 'description': 'Chemotherapy infusion on Day 1 of a 3-week cycle', 'interventionNames': ['Drug: Pemetrexed', 'Drug: Cisplatin', 'Drug: Bevacizumab']}], 'interventions': [{'name': 'Pemetrexed', 'type': 'DRUG', 'otherNames': ['Alimta'], 'description': '1. Pre-hydration for 1-1/2 hours at 250 ml/hour\n2. Pemetrexed 500 mg/m2 IV over 10 minutes\n3. Return to hydration for 30 minutes at 250 ml/hour', 'armGroupLabels': ['Pemetrexed, Cisplatin, Bevacizumab']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['No brands available'], 'description': '4\\. Cisplatin 75mg/m2 IV over 60-120 minutes', 'armGroupLabels': ['Pemetrexed, Cisplatin, Bevacizumab']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': '5\\. Bevacizumab 15mg/kg IV over 90 minutes', 'armGroupLabels': ['Pemetrexed, Cisplatin, Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mark Stoopler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}