Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2026-01-04 @ 2:39 PM
Study NCT ID:
NCT00137761
Status:
COMPLETED
Last Update Posted:
2009-11-02
First Post:
2005-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Docetaxel in Combination With Iressa in Previously Treated Patients With Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000077156', 'term': 'Gefitinib'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-30', 'studyFirstSubmitDate': '2005-08-26', 'studyFirstSubmitQcDate': '2005-08-26', 'lastUpdatePostDateStruct': {'date': '2009-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'To determine the safety, radiologic response rate, progression-free survival and overall survival of patients treated with Iressa and docetaxel'}]}, 'conditionsModule': {'keywords': ['Pancreatic Carcinoma', 'Iressa', 'Docetaxel'], 'conditions': ['Metastatic Pancreatic Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out what activity the combination of docetaxel and Iressa have against metastatic pancreatic cancer.', 'detailedDescription': 'Iressa will be taken orally once daily without interruption. Docetaxel will be administered intravenously once weekly for two out of every three weeks. Patients will also receive dexamethasone the night prior, morning of, and the evening after docetaxel treatment to help prevent an allergic reaction.\n\nEvery week that chemotherapy is given, blood tests and vital signs will be taken.\n\nAfter the first 6 weeks of therapy a CT scan (or other radiological procedure) will be done to assess the progress of the disease. If the cancer is responding to the treatment and no unacceptable side effects have occured, treatment with Iressa and docetaxel will continue.\n\nCT scans (or other radiological procedure) will be performed at week 12 and every 9 weeks thereafter to monitor the progress of the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors); histologic confirmation of either the primary or metastatic site.\n* ECOG performance status of \\< 1\n* \\> 4 weeks since completion of previous chemotherapy\n* \\> 4 weeks since participation in any investigational drug study\n* Peripheral neuropathy of grade \\< 1\n* Patients must have failed a gemcitabine-containing regimen administered in the metastatic, adjuvant, or locally advanced setting.\n* Absolute neutrophil count (ANC) \\> 1,500/mm3\n* Hemoglobin \\> 9.0gm/dl\n* Platelets \\> 100,000/mm3\n* Total bilirubin \\< 2.0mg/dl\n* AST and alkaline phosphatase \\< 5 x upper limit of normal (ULN)\n* Albumin \\> 2.5gm/dl\n* CA 19-9 \\> 1.5 x ULN\n\nExclusion Criteria:\n\n* Prior therapy with taxane or with epidermal growth factor receptor (EGFR) inhibitors\n* More than one prior chemotherapy treatment\n* Clinically significant cardiac disease\n* Major surgery within 4 weeks of the start of study treatment\n* Evidence of central nervous system (CNS) metastases or carcinomatous meningitis or history of uncontrolled seizures, central nervous system disorders.\n* Uncontrolled serious medical or psychiatric illness\n* Pregnant or breast-feeding women\n* Other active malignancy\n* Inability to swallow tablets or evidence of a gastrointestinal malabsorption syndrome\n* Known severe hypersensitivity to Iressa\n* Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's wort.\n* History of severe hypersensitivity reaction to drugs formulated with polysorbate 80\n* Any evidence of clinically active interstitial lung disease\n* Ascites requiring paracentesis"}, 'identificationModule': {'nctId': 'NCT00137761', 'briefTitle': 'Docetaxel in Combination With Iressa in Previously Treated Patients With Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Dana-Farber Cancer Institute'}, 'officialTitle': 'A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': '04-173'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ZD 1839', 'type': 'DRUG', 'otherNames': ['Iressa'], 'description': 'Taken orally once daily'}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Given intravenously once weekly for 2 out of 3 weeks'}]}, 'contactsLocationsModule': {'locations': [{'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}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Matthew Kulke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Matthew Kulke, MD', 'oldOrganization': 'Dana-Farber Cancer Institute'}}}}