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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Gemcitabine + Capecitabine
Gemcitabine alone
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allgemeines Krankenhaus der Stadt Wien
  • Tel-Aviv Sourasky Medical Center
  • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • Kantonspital Aarau
  • Saint Claraspital AG
  • Universitatsspital-Basel
  • Inselspital, Bern
  • Spitalzentrum Biel
  • Ratisches Kantons und Regionalspital
  • Hopital Cantonal Universitaire de Geneve
  • Centre Hospitalier Universitaire Vaudois
  • Institut Central des Hopitaux Valaisans
  • Kantonsspital - St. Gallen
  • Regionalspital
  • City Hospital Triemli
  • Oncology Institute of Southern Switzerland
  • UniversitaetsSpital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Gemcitabine + Capecitabine

Gemcitabine alone

Arm Description

Gemcitabine + Capecitabine

Gemcitabine alone

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
May 14, 2019
Sponsor
Swiss Group for Clinical Cancer Research
Collaborators
Central European Cooperative Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00030732
Brief Title
Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer
Official Title
Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research
Collaborators
Central European Cooperative Oncology Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
319 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine + Capecitabine
Arm Type
Active Comparator
Arm Description
Gemcitabine + Capecitabine
Arm Title
Gemcitabine alone
Arm Type
Active Comparator
Arm Description
Gemcitabine alone
Intervention Type
Drug
Intervention Name(s)
Gemcitabine + Capecitabine
Intervention Description
Gemcitabine + Capecitabine
Intervention Type
Drug
Intervention Name(s)
Gemcitabine alone
Intervention Description
Gemcitabine alone
Primary Outcome Measure Information:
Title
Gemcitabine + Capecitabine vs. Gemcitabine alone
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Herrmann, MD
Organizational Affiliation
Universitaetsspital-Basel
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Werner Scheithauer, MD
Organizational Affiliation
Allgemeines Krankenhaus - Universitatskliniken
Official's Role
Study Chair
Facility Information:
Facility Name
Allgemeines Krankenhaus der Stadt Wien
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Kantonspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Saint Claraspital AG
City
Basel
ZIP/Postal Code
CH-4016
Country
Switzerland
Facility Name
Universitatsspital-Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Inselspital, Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Spitalzentrum Biel
City
Biel
ZIP/Postal Code
CH-2501
Country
Switzerland
Facility Name
Ratisches Kantons und Regionalspital
City
Chur
ZIP/Postal Code
CH-7000
Country
Switzerland
Facility Name
Hopital Cantonal Universitaire de Geneve
City
Geneva
ZIP/Postal Code
CH-1211
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Institut Central des Hopitaux Valaisans
City
Sion
ZIP/Postal Code
CH1951
Country
Switzerland
Facility Name
Kantonsspital - St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Regionalspital
City
Thun
ZIP/Postal Code
3600
Country
Switzerland
Facility Name
City Hospital Triemli
City
Zurich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Oncology Institute of Southern Switzerland
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
UniversitaetsSpital
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20877359
Citation
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 Cancer. 2010 Oct 26;103(9):1318-24. doi: 10.1038/sj.bjc.6605929. Epub 2010 Sep 28.
Results Reference
result
PubMed Identifier
18669454
Citation
Bernhard J, Dietrich D, Scheithauer W, Gerber D, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schuller J, Saletti P, Bauer J, Figer A, Pestalozzi BC, Kohne CH, Mingrone W, Stemmer SM, Tamas 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. doi: 10.1200/JCO.2007.15.6240.
Results Reference
result
PubMed Identifier
18249033
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 trial. Lancet Oncol. 2008 Feb;9(2):132-8. doi: 10.1016/S1470-2045(08)70001-9.
Results Reference
result
PubMed Identifier
17538165
Citation
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. doi: 10.1200/JCO.2006.09.0886.
Results Reference
result
PubMed Identifier
30636977
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 chemotherapy in a multicentre phase III randomized clinical trial: the APC-SAKK risk scores. Ther Adv Med Oncol. 2019 Jan 2;11:1758835918818351. doi: 10.1177/1758835918818351. eCollection 2019.
Results Reference
result

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

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