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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Genentech Roche Global Development Brigham and Women's Hospital Massachusetts General Hospital Beth Israel Deaconess Medical Center |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00125021 |
This phase II trial is designed to investigate the effectiveness of Tarceva (OSI-774) combined with capecitabine in treating patients with metastatic pancreatic cancer.
Condition | Intervention | Phase |
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Pancreatic Cancer Neoplasm Metastasis |
Drug: Capecitabine Drug: OSI-774 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of OSI-774 (Tarceva) in Combination With Capecitabine in Previously Treated Patients With Metastatic Pancreatic Cancer |
Enrollment: | 32 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | June 2008 |
Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
Patients will be treated once daily with Tarceva, twice daily with capecitabine for 14 consecutive days, followed by 7 days off of capecitabine (a cycle is 21 days). At week 1 of each cycle a physical exam and blood work will be performed. Reassessment of tumor size will be conducted at 6 weeks (2 cycles), 12 weeks (4 cycles) and then every 9 weeks thereafter. Patients will remain on treatment until one of the following occur: disease progression, illness that prevents further treatment or unacceptable adverse events.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory values:
Exclusion Criteria:
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
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: | 03-070 |
Study First Received: | July 27, 2005 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00125021 |
Health Authority: | United States: Food and Drug Administration |
Second Line Therapy Gemcitabine Refractory Pancreatic Cancer Capecitabine |
Tarceva OSI-774 Metastatic Pancreatic Cancer |
Erlotinib Capecitabine Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Neoplasm Metastasis |
Endocrine System Diseases Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Neoplasms Neoplastic Processes Antimetabolites, Antineoplastic Neoplasms by Site Pathologic Processes |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |