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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00030732
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
Central European Cooperative Oncology Group
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief 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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine + Capecitabine Drug: Gemcitabine alone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 319 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial
Study Start Date : June 2001
Actual Primary Completion Date : June 2004
Actual Study Completion Date : April 2008


Arm Intervention/treatment
Active Comparator: Gemcitabine + Capecitabine
Gemcitabine + Capecitabine
Drug: Gemcitabine + Capecitabine
Gemcitabine + Capecitabine

Active Comparator: Gemcitabine alone
Gemcitabine alone
Drug: Gemcitabine alone
Gemcitabine alone




Primary Outcome Measures :
  1. Gemcitabine + Capecitabine vs. Gemcitabine alone [ Time Frame: 8 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030732


Locations
Show Show 18 study locations
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Central European Cooperative Oncology Group
Investigators
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Study Chair: Richard Herrmann, MD Universitaetsspital-Basel
Study Chair: Werner Scheithauer, MD Allgemeines Krankenhaus - Universitatskliniken

Publications of Results:
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.

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Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00030732    
Other Study ID Numbers: SAKK 44/00
SWS-SAKK-44/00 ( Other Identifier: SAKK )
CECOG/PAN-1.3.001
EU-20142
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Keywords provided by Swiss Group for Clinical Cancer Research:
stage III pancreatic cancer
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs