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| Sponsor: | Swiss Group for Clinical Cancer Research |
|---|---|
| Collaborator: |
Central European Cooperative Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030732 |
Purpose
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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| 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 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III pancreatic cancer recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
|
Antimetabolites Anti-Infective Agents Capecitabine Digestive System Neoplasms Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Endocrine System Diseases Enzyme Inhibitors |
Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Digestive System Diseases Radiation-Sensitizing Agents Therapeutic Uses Pancreatic Diseases Gemcitabine Endocrine Gland Neoplasms |