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

Sponsor

Swiss Group for Clinical Cancer Research (Other)

Overall Status

Completed

CT.gov ID

NCT00030732

Collaborator

Central European Cooperative Oncology Group (Other)

319

Enrollment

Locations

Arms

Duration (Months)

17.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

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 :

Jun 1, 2001

Actual Primary Completion Date :

Jun 1, 2004

Actual Study Completion Date :

Apr 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Gemcitabine + Capecitabine vs. Gemcitabine alone [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Allgemeines Krankenhaus der Stadt Wien	Vienna	Austria	A-1090
2	Tel-Aviv Sourasky Medical Center	Tel-Aviv	Israel	64239
3	Istituto Nazionale per lo Studio e la Cura dei Tumori	Milan	Italy	20133
4	Istituto Nazionale per lo Studio e la Cura dei Tumori	Naples	Italy	80131
5	Kantonspital Aarau	Aarau	Switzerland	5001
6	Saint Claraspital AG	Basel	Switzerland	CH-4016
7	Universitatsspital-Basel	Basel	Switzerland	CH-4031
8	Inselspital, Bern	Bern	Switzerland	CH-3010
9	Spitalzentrum Biel	Biel	Switzerland	CH-2501
10	Ratisches Kantons und Regionalspital	Chur	Switzerland	CH-7000
11	Hopital Cantonal Universitaire de Geneve	Geneva	Switzerland	CH-1211
12	Centre Hospitalier Universitaire Vaudois	Lausanne	Switzerland	CH-1011
13	Institut Central des Hopitaux Valaisans	Sion	Switzerland	CH1951
14	Kantonsspital - St. Gallen	St. Gallen	Switzerland	CH-9007
15	Regionalspital	Thun	Switzerland	3600
16	City Hospital Triemli	Zurich	Switzerland	8063
17	Oncology Institute of Southern Switzerland	Zurich	Switzerland	CH-8091
18	UniversitaetsSpital	Zurich	Switzerland	CH-8091