Gemcitabine With Or Without Capecitabine In Treating Patients With Advanced Pancreatic Cancer

Study Overview

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

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.

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.

Pancreatic Cancer

DRUG: Gemcitabine + Capecitabine
DRUG: Gemcitabine alone

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

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2002-02-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-05-14
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-05-15
First Posted (ACTUAL) 2003-01-27	Results First Posted N/A	Last Verified 2019-05

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Factorial

Masking:
None

Arms and Interventions

Participant Group/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

Participant Group/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

Primary Outcome Measures	Measure Description	Time Frame
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.	8 weeks

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed primary inoperable or metastatic pancreatic adenocarcinoma
No CNS metastases

Over 18

Karnofsky 60-100%

Not specified

WBC at least 3,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 10.0 g/dL

Bilirubin no greater than 5 times normal
AST/ALT no greater than 5 times normal
Alkaline phosphatase no greater than 5 times normal

Creatinine clearance at least 30 mL/min

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)

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

Not specified

No prior capecitabine
No prior chemotherapy for advanced pancreatic cancer
At least 1 year since prior radiochemotherapy for pancreatic cancer

Not specified

See Chemotherapy
At least 1 year since prior adjuvant radiotherapy for pancreatic cancer
No concurrent radiotherapy

Prior Whipple procedure or duodenal bypass allowed

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

Collaborators and Investigators

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

Central European Cooperative Oncology Group

Investigators

STUDY_CHAIR: Richard Herrmann, MD, Universitaetsspital-Basel

Publications

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

General 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 Oct 26;103(9):1318-24. doi: 10.1038/sj.bjc.6605929. Epub 2010 Sep 28.
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.
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.
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.
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.

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