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

This study has been completed.

Sponsor:

Collaborator:

Central European Cooperative Oncology Group

Information provided by (Responsible Party):

Swiss Group for Clinical Cancer Research

ClinicalTrials.gov Identifier:

NCT00030732

First received: February 14, 2002

Last updated: May 14, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 14, 2002

Last Updated Date

May 14, 2012

Start Date ^ICMJE

June 2001

Primary Completion Date

June 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Gemcitabine + Capecitabine vs. Gemcitabine alone [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00030732 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pancreatic Cancer

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Gemcitabine + Capecitabine
Gemcitabine + Capecitabine

Intervention: Drug: Gemcitabine + Capecitabine
Active Comparator: Gemcitabine alone
Gemcitabine alone

Intervention: Drug: Gemcitabine alone

Publications *

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 Sep 28; [Epub ahead of print]
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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

319

Completion Date

April 2008

Primary Completion Date

June 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Israel, Italy, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00030732

Other Study ID Numbers ^ICMJE

SAKK 44/00, SWS-SAKK-44/00, CECOG/PAN-1.3.001, EU-20142

Has Data Monitoring Committee

Yes

Responsible Party

Swiss Group for Clinical Cancer Research

Study Sponsor ^ICMJE

Swiss Group for Clinical Cancer Research

Collaborators ^ICMJE

Central European Cooperative Oncology Group

Investigators ^ICMJE

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

Information Provided By

Swiss Group for Clinical Cancer Research

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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