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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Massachusetts General Hospital Beth Israel Deaconess Medical Center Brigham and Women's Hospital |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00137761 |
The purpose of this study is to find out what activity the combination of docetaxel and Iressa have against metastatic pancreatic cancer.
Condition | Intervention | Phase |
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Metastatic Pancreatic Carcinoma |
Drug: ZD 1839 Drug: Docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer |
Enrollment: | 32 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | June 2009 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
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.
Every week that chemotherapy is given, blood tests and vital signs will be taken.
After 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.
CT scans (or other radiological procedure) will be performed at week 12 and every 9 weeks thereafter to monitor the progress of the disease.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02115 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Matthew Kulke, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Matthew Kulke, MD ) |
Study ID Numbers: | 04-173 |
Study First Received: | August 26, 2005 |
Last Updated: | December 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00137761 History of Changes |
Health Authority: | United States: Institutional Review Board |
Pancreatic Carcinoma Iressa Docetaxel |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Protein Kinase Inhibitors Carcinoma Docetaxel Digestive System Diseases |
Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Gefitinib Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Endocrine System Diseases Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Docetaxel Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Pancreatic Diseases Gefitinib Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |