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Study 19 of 950 for search of: | United States, Vermont |
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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00012220 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective when given alone or in combination with another chemotherapy drug in treating cancer of the pancreas.
PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine given alone or in combination with other chemotherapy drugs in treating patients who have metastatic cancer of the pancreas.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: cisplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase II Study Of Gemcitabine/Cisplatin, Gemcitabine/Docetaxel, Gemcitabine/Irinotecan, Or Fixed Dose Rate Infusion Gemcitabine In Patients With Metastic Pancreatic Cancer |
Study Start Date: | January 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of four treatment arms.
Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 240 patients (60 per arm) will be accrued for this study within 30 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Matthew Kulke, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000068495, CALGB-89904 |
Study First Received: | March 3, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00012220 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the pancreas stage IV pancreatic cancer |
Digestive System Neoplasms Pancreatic Neoplasms Irinotecan Endocrine System Diseases Pancrelipase Camptothecin Docetaxel Digestive System Diseases |
Cisplatin Neoplasm Metastasis Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Antineoplastic Agents, Phytogenic |