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

May 14, 2019 updated by: Swiss Group for Clinical Cancer Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

319

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • Allgemeines Krankenhaus der Stadt Wien
  • Israel
      • Tel-Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center
  • Italy
      • Milan, Italy, 20133
        • Istituto Nazionale per lo Studio e la Cura dei Tumori
      • Naples, Italy, 80131
        • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonspital Aarau
      • Basel, Switzerland, CH-4016
        • Saint Claraspital AG
      • Basel, Switzerland, CH-4031
        • Universitatsspital-Basel
      • Bern, Switzerland, CH-3010
        • Inselspital, Bern
      • Biel, Switzerland, CH-2501
        • Spitalzentrum Biel
      • Chur, Switzerland, CH-7000
        • Ratisches Kantons und Regionalspital
      • Geneva, Switzerland, CH-1211
        • Hôpital Cantonal Universitaire de Genève
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • Sion, Switzerland, CH1951
        • Institut Central des Hopitaux Valaisans
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen
      • Thun, Switzerland, 3600
        • Regionalspital
      • Zurich, Switzerland, CH-8091
        • UniversitaetsSpital
      • Zurich, Switzerland, 8063
        • City Hospital Triemli
      • Zurich, Switzerland, CH-8091
        • Oncology Institute of Southern Switzerland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gemcitabine + Capecitabine
Drug: Gemcitabine + Capecitabine
Gemcitabine + Capecitabine
Active Comparator: Gemcitabine alone
Drug: Gemcitabine alone
Gemcitabine alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Group for Clinical Cancer Research

Collaborators

Central European Cooperative Oncology Group

Investigators

  • Study Chair: Richard Herrmann, MD, Universitaetsspital-Basel
  • Study Chair: Werner Scheithauer, MD, Allgemeines Krankenhaus - Universitatskliniken

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

February 14, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAKK 44/00
  • SWS-SAKK-44/00 (Other Identifier: SAKK)
  • CECOG/PAN-1.3.001
  • EU-20142

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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