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Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Swiss Group for Clinical Cancer Research
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

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Capecitabine Pancrelipase Ultrase
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2001
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030732

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
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Central European Cooperative Oncology Group
Investigators
Study Chair: Richard Herrmann, MD Universitaetsspital-Basel
Study Chair: Werner Scheithauer, MD Allgemeines Krankenhaus - Universitatskliniken
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
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 Cooperative Oncology Group. Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial--SAKK 44/00-CECOG/PAN.1.3.001. J Clin Oncol. 2008 Aug 1;26(22):3695-701.
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 trial. Lancet Oncol. 2008 Feb;9(2):132-8.
Herrmann R, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schuller J, Saletti P, Bauer J, Figer A, Pestalozzi B, Kohne CH, Mingrone W, Stemmer SM, Tamas K, Kornek GV, Koeberle D, Cina S, Bernhard J, Dietrich D, Scheithauer W; Swiss Group for Clinical Cancer Research; Central European Cooperative Oncology Group. Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol. 2007 Jun 1;25(16):2212-7.
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 European Cooperative Oncology Group (CECOG). [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA4010, 310s, 2005.

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

Keywords provided by National Cancer Institute (NCI):
stage III pancreatic cancer
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Study placed in the following topic categories:
Capecitabine
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancrelipase
Recurrence
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 15, 2009