Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

February 14, 2002

Last Updated Date

August 13, 2008

Start Date ^ICMJE

June 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

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

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Active Control

Condition ^ICMJE

Pancreatic Cancer

Intervention ^ICMJE

Drug: capecitabine
Drug: gemcitabine hydrochloride

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

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 ID ^ICMJE

NCT00030732

Responsible Party

Study ID Numbers ^ICMJE

CDR0000069193, SWS-SAKK-44/00, CECOG/PAN-1.3.001, EU-20142

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

National Cancer Institute (NCI)

Verification Date

August 2008

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