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Study 4 of 2072 for search of: | United States, Utah |
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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00026104 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy and radiation therapy with tipifarnib may be an effective treatment for pancreatic cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of gemcitabine, paclitaxel, and radiation therapy with or without tipifarnib in treating patients who have locally advanced pancreatic cancer.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: tipifarnib Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Randomized Phase II Trial Of Weekly Gemcitabine, Paclitaxel And External Irradiation (50.4GY) Followed By The Farnesyl Transferase Inhibitor R115777 (NSC # 702818) For Locally Advanced Pancreatic Cancer |
Study Start Date: | November 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss in the preceding 6 months (more than 10% vs 10% or less) and tumor dimension (at least 5 cm vs less than 5 cm). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 154 patients (77 per treatment arm) will be accrued for this study within approximately 20 months.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed unresectable, locally advanced adenocarcinoma of the pancreas
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Tyvin A. Rich, MD | University of Virginia |
Study ID Numbers: | CDR0000068986, RTOG-PA-0020, RTOG-DEV-1003 |
Study First Received: | November 9, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00026104 |
Health Authority: | United States: Federal Government |
stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancrelipase Digestive System Diseases Paclitaxel Gastrointestinal Neoplasms |
Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Endocrine Gland Neoplasms Tipifarnib |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Enzyme Inhibitors Antimitotic Agents |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic |