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Sponsors and Collaborators: |
Swiss Group for Clinical Cancer Research Central European Cooperative Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00030732 |
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 with or without capecitabine in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with or without capecitabine in treating patients who have advanced pancreatic cancer.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: capecitabine Drug: gemcitabine hydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial |
Study Start Date: | June 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to metastases (yes vs no), pain (yes vs no), Karnofsky performance status (60-80% vs 90-100%), and participating center. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, weekly for weeks 2-7, and then before each gemcitabine administration.
Patients are followed every 9 weeks.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.
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:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Austria | |
Allgemeines Krankenhaus der Stadt Wien | |
Vienna, Austria, A-1090 | |
Israel | |
Tel-Aviv Sourasky Medical Center | |
Tel-Aviv, Israel, 64239 | |
Italy | |
Istituto Nazionale per lo Studio e la Cura dei Tumori | |
Naples, Italy, 80131 | |
Istituto Nazionale per lo Studio e la Cura dei Tumori | |
Milan, Italy, 20133 | |
Switzerland | |
Centre Hospitalier Universitaire Vaudois | |
Lausanne, Switzerland, CH-1011 | |
City Hospital Triemli | |
Zurich, Switzerland, 8063 | |
Hopital Cantonal Universitaire de Geneve | |
Geneva, Switzerland, CH-1211 | |
Inselspital, Bern | |
Bern, Switzerland, CH-3010 | |
Institut Central des Hopitaux Valaisans | |
Sion, Switzerland, CH1951 | |
Universitatsspital-Basel | |
Basel, Switzerland, CH-4031 | |
Kantonsspital - St. Gallen | |
St. Gallen, Switzerland, CH-9007 | |
Oncology Institute of Southern Switzerland | |
Zurich, Switzerland, CH-8091 | |
Ratisches Kantons und Regionalspital | |
Chur, Switzerland, CH-7000 | |
Regionalspital | |
Thun, Switzerland, 3600 | |
Saint Claraspital AG | |
Basel, Switzerland, CH-4016 | |
Spitalzentrum Biel | |
Biel, Switzerland, CH-2501 | |
UniversitaetsSpital | |
Zurich, Switzerland, CH-8091 | |
Kantonspital Aarau | |
Aarau, Switzerland, 5001 |
Study Chair: | Richard Herrmann, MD | Universitaetsspital-Basel |
Study Chair: | Werner Scheithauer, MD | Allgemeines Krankenhaus - Universitatskliniken |
Study ID Numbers: | CDR0000069193, SWS-SAKK-44/00, CECOG/PAN-1.3.001, EU-20142 |
Study First Received: | February 14, 2002 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00030732 |
Health Authority: | United States: Federal Government |
stage III pancreatic cancer recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
Capecitabine Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancrelipase Recurrence Digestive System Diseases |
Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |