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Home > "G" Clinical Trials Conditions > Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer  Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer
Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer
For Condition: recurrent pancreatic cancer,stage 4A pancreatic cancer,stage 3 pancreatic cancer,adenocarcinoma of the pancreas,stage 4B pancreatic cancer
Status: Recruiting
Sponsor(s): Swiss Institute for Applied Cancer Research , Central European Cooperative Oncology Group
Synopsis: 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: Randomizedphase III trial to determine the effectiveness of gemcitabine with or without capecitabine in treating patients who have advanced pancreatic cancer.
Details: OBJECTIVES: - Compare the overall survival of patients with advanced pancreatic cancer treated with gemcitabine with or without capecitabine. - Compare the clinical benefit response, objective tumor response, duration of response, and time to progression in patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Compare the quality of life of patients treated with these regimens. 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. - Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. - Arm II: Patients initially receive gemcitabine IV over 30 minutes weekly for 7 weeks. After 1 week of rest, patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Treatment then repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed primary inoperable or metastatic pancreatic adenocarcinoma - No CNS metastases PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - WBC at least 3,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL Hepatic: - Bilirubin no greater than 5 times normal - AST/ALT no greater than 5 times normal - Alkaline phosphatase no greater than 5 times normal Renal: - Creatinine clearance at least 30 mL/min Gastrointestinal: - No grade 2 or greater nausea or grade 1 or greater vomiting - No medical condition that would interfere with taking oral medications or with gastrointestinal absorption (e.g., small bowel obstruction) Other: - No prior unanticipated severe reaction to fluoropyrimidine therapy - No known hypersensitivity to fluorouracil - No known dihydropyrimidine dehydrogenase deficiency - No active infection - No other serious concurrent systemic disorders that would preclude study participation - No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior capecitabine - No prior chemotherapy for advanced pancreatic cancer - At least 1 year since prior radiochemotherapy for pancreatic cancer Endocrine therapy: - Not specified Radiotherapy: - See Chemotherapy - At least 1 year since prior adjuvant radiotherapy for pancreatic cancer - No concurrent radiotherapy Surgery: - Prior Whipple procedure or duodenal bypass allowed Other: - At least 1 month since prior investigational agents - No concurrent sorivudine or its chemically related analogues (e.g., brivudine) - No other concurrent anticancer or investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WernerScheithauer, Study Chair, Allgemeines Krankenhaus der Stadt Wien
Institut Central des Hopitaux Valaisans *Recruiting*
Sion, , CH1951
Switzerland
Recruiting Reto Obrist 41-27-603-4786
Ratisches Kantons und Regionalspital *Recruiting*
Chur, , CH-7000
Switzerland
Recruiting Fritz Egli 41-81-256-6111
Istituto Nazionale per lo Studio e la Cura dei Tumori *Recruiting*
Milano (Milan), , 20133
Italy
Recruiting Emilio Bajetta 39-02-2390-500
Regionalspital *Recruiting*
Thun, , 3600
Switzerland
Recruiting Jean Luthi 41-33-262-924
Universitatsklinken Basel *Recruiting*
Basel, , CH-4031
Switzerland
Recruiting Richard Herrmann 41-61-265-5075
Istituto Nazionale per lo Studio e la Cura dei Tumori *Recruiting*
Naples, , 80131
Italy
Recruiting Pasquale Comella 39-81-590-3227
Kantonspital Aarau *Recruiting*
AARAU, , 5001
Switzerland
Recruiting Martin Wernil 01141-62-838-6053
City Hospital Triemli *Recruiting*
Zurich, , 8063
Switzerland
Recruiting H.P. Honegger 0041-1-4661111
Ospedale San Giovanni *Recruiting*
Zurich, , CH-8091
Switzerland
Recruiting Bernhard Pestalozzi 41-31-255-2214
Saint Claraspital AG *Recruiting*
Basel, , CH-4016
Switzerland
Recruiting Christian Ludwig 41-61-685-8470
Spitalzentrum Biel *Recruiting*
Biel, , CH-2501
Switzerland
Recruiting Urban Laffer 41-32-324-3784
Kantonsspital - St. Gallen *Recruiting*
St. Gallen, , CH-9007
Switzerland
Recruiting Rudolf Morant 41-71-494-1062
Hopital Cantonal Universitaire de Geneve *Recruiting*
Geneva, , CH-1211
Switzerland
Recruiting Arnaud Roth 41-22-372-7744
Centre Hospitalier Universitaire Vaudois *Recruiting*
Lausanne, , CH-1011
Switzerland
Recruiting Roger Stupp 41-21-314-0156
UniversitaetsSpital *Recruiting*
Zurich, , CH-8091
Switzerland
Recruiting Bernhard Pestalozzi 41-31-255-2214
Inselspital, Bern *Recruiting*
Bern, , CH-3010
Switzerland
Recruiting Markus Borner 41-31-632-4114
Tel-Aviv Sourasky Medical Center *Recruiting*
Tel Aviv, , 64239
Israel
Recruiting Moshe Inbar 972-3-697-3494
Allgemeines Krankenhaus der Stadt Wien *Recruiting*
Vienna, , A-1090
Austria
Recruiting Werner Scheithauer 43-1-404005462
Additional Information:
Study ID Numbers: CDR0000069193; CECOG/PAN-1.3.001,SWS-SAKK-44/00,EU-20142
Study Start Date:
Record last reviewed: February 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030732
Other Adenocarcinoma Of The Pancreas Studies:
1. BMS-247550 in Treating Patients With Advanced Pancreatic Cancer
2. DHA-Paclitaxel With or Without Gemcitabine in Treating Patients With Advanced Solid Tumors or Unresectable Pancreatic Cancer
3. R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
4. Gemcitabine and Celecoxib in Treating Patients With Metastatic Pancreatic Cancer
5. CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Related Studies:
Other adenocarcinoma of the pancreas Clinical Trials
Other Clinical Trials
Other Zurich Clinical Trials
Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer
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