Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030732
• Other study ID #: SAKK 44/00
• Secondary ID: SWS-SAKK-44/00CE
• Status: Completed
• Phase: Phase 3
• Start date: June 2001
• Est. completion date: April 2008

Study information

• Verified date: May 2019
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: April 2008
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine + Capecitabine
Gemcitabine + Capecitabine
• Gemcitabine alone
Gemcitabine alone

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus der Stadt Wien	Vienna
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori	Milan
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori	Naples
Switzerland	Kantonspital Aarau	Aarau
Switzerland	Saint Claraspital AG	Basel
Switzerland	Universitatsspital-Basel	Basel
Switzerland	Inselspital, Bern	Bern
Switzerland	Spitalzentrum Biel	Biel
Switzerland	Ratisches Kantons und Regionalspital	Chur
Switzerland	Hopital Cantonal Universitaire de Geneve	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Institut Central des Hopitaux Valaisans	Sion
Switzerland	Kantonsspital - St. Gallen	St. Gallen
Switzerland	Regionalspital	Thun
Switzerland	City Hospital Triemli	Zurich
Switzerland	Oncology Institute of Southern Switzerland	Zurich
Switzerland	UniversitaetsSpital	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research	Central European Cooperative Oncology Group

Countries where clinical trial is conducted

Austria,  Israel,  Italy,  Switzerland, 

References & Publications (6)

Bernhard J, Dietrich D, Glimelius B, Hess V, Bodoky G, Scheithauer W, Herrmann R. Estimating prognosis and palliation based on tumour marker CA 19-9 and quality of life indicators in patients with advanced pancreatic cancer receiving chemotherapy. Br J Ca — View Citation

Bernhard J, Dietrich D, Scheithauer W, Gerber D, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schüller J, Saletti P, Bauer J, Figer A, Pestalozzi BC, Köhne CH, Mingrone W, Stemmer SM, Tàmas K, Kornek GV, Koeberle D, Herrmann R; Central European Coopera — View Citation

Gargiulo P, Dietrich D, Herrmann R, Bodoky G, Ruhstaller T, Scheithauer W, Glimelius B, Berardi S, Pignata S, Brauchli P. Predicting mortality and adverse events in patients with advanced pancreatic cancer treated with palliative gemcitabine-based chemoth — View Citation

Herrmann R, Bodoky G, Ruhstaller T, et al.: Gemcitabine (G) plus capecitabine (C) versus G alone in locally advanced or metastatic pancreatic cancer. A randomized phase III study of the Swiss Group for Clinical Cancer Research (SAKK) and the Central Europ

Herrmann R, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schüller J, Saletti P, Bauer J, Figer A, Pestalozzi B, Köhne CH, Mingrone W, Stemmer SM, Tàmas K, Kornek GV, Koeberle D, Cina S, Bernhard J, Dietrich D, Scheithauer W; Swiss Group for Clinical Ca — View Citation

Hess V, Glimelius B, Grawe P, Dietrich D, Bodoky G, Ruhstaller T, Bajetta E, Saletti P, Figer A, Scheithauer W, Herrmann R. CA 19-9 tumour-marker response to chemotherapy in patients with advanced pancreatic cancer enrolled in a randomised controlled tria — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gemcitabine + Capecitabine vs. Gemcitabine alone	To compare survival, efficacy, quality of life and toxicity between the combination therapy (Capecitabine and Gemcitabine) and the monotherapy (Gemcitabine alone) in advanced pancreatic cancer.	8 weeks