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

Study Overview

Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic 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 compare the effectiveness of gemcitabine with or without capecitabine in treating patients who have locally advanced or metastatic pancreatic cancer.

OBJECTIVES: * Compare the 1-year survival rate of patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without capecitabine. * Compare the median and 2-year survival rates and the objective response rates of 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 an randomized, open-label, multicenter study. Patients are stratified according to disease stage (locally advanced vs metastatic) and performance status (0 and 1 vs 2). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 during the first course. After a 1-week rest period, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Subsequent courses repeat every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 3 months for 1 year, and then annually thereafter. Patients are followed every 3 months. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 508 patients (254 per treatment arm) will be accrued for this study.

Pancreatic Cancer

DRUG: capecitabine
DRUG: gemcitabine hydrochloride

CRUK-GEM-CAP
CDR0000069263 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))
EU-20116
ISRCTN11513444

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 2002-03-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-06-25
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-06-26
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2007-04

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:
N/A

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Survival at 1 year

Secondary Outcome Measures	Measure Description	Time Frame
Quality of life
Median survival rate
Survival rate at 2 years
Toxicity
Objective response rate

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 ductal adenocarcinoma of the pancreas

Locally advanced or metastatic disease not amenable to curative surgical resection
Macroscopic residual disease after prior resection with histological confirmation is allowed
Unidimensionally measurable disease
No intracerebral metastases or meningeal carcinomatosis

Over 18

WHO 0-2

More than 3 months

WBC greater than 3,000/mm3
Neutrophil count greater than 1,500/mm3
Platelet count greater than 100,000/mm3

Bilirubin less than 2 mg/dL

Creatinine less than 2 mg/dL
Creatinine clearance greater than 50 mL/min

No New York Heart Association class III or IV heart disease
No uncontrolled angina pectoris

No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
No other concurrent uncontrolled medical condition
No other medical or psychiatric condition that would preclude study
No known hypersensitivity to fluorouracil
No dihydropyrimidine dehydrogenase deficiency
No known malabsorption syndromes
Not pregnant or nursing
Fertile patients must use effective contraception

Not specified

No prior chemotherapy (including preoperative or adjuvant) for this disease
No other concurrent cytotoxic chemotherapy

Not specified

No prior radiotherapy (including preoperative or adjuvant) for this disease

See Disease Characteristics

No prior investigational drugs (including preoperative or adjuvant) for this disease
No other concurrent investigational drugs
No concurrent dipyridamole or allopurinol
No concurrent sorivudine or sorivudine analogs (e.g., brivudine) (capecitabine arm only)

Collaborators and Investigators

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

Investigators

: Emily Owen, Cancer Research UK

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

Cunningham D, Chau I, Stocken DD, Valle JW, Smith D, Steward W, Harper PG, Dunn J, Tudur-Smith C, West J, Falk S, Crellin A, Adab F, Thompson J, Leonard P, Ostrowski J, Eatock M, Scheithauer W, Herrmann R, Neoptolemos JP. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2009 Nov 20;27(33):5513-8. doi: 10.1200/JCO.2009.24.2446. Epub 2009 Oct 26.

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Clinical Trial Record