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

June 25, 2013 updated by: Cancer Research UK

A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of 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 compare the effectiveness of gemcitabine with or without capecitabine in treating patients who have locally advanced or metastatic pancreatic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

508

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • United Kingdom
    • England
      • Bath, England, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Bournemouth, England, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology centre
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
      • Derby, England, United Kingdom, DE1 2QY
        • Derbyshire Royal Infirmary
      • Exeter, England, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Ipswich, England, United Kingdom, IP4 5PD
        • Ipswich Hospital NHS Trust
      • King's Lynn, England, United Kingdom, PE30 4ET
        • Queen Elizabeth Hospital
      • Leeds, England, United Kingdom, LS16 6QB
        • Cookridge Hospital at Leeds Teaching Hospital NHS Trust
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • Lincoln, England, United Kingdom, LN2 5QY
        • Lincoln County Hospital
      • Liverpool, England, United Kingdom, L69 3GA
        • Royal Liverpool University Hospital
      • Liverpool, England, United Kingdom, L3 9TA
        • Cancer Research UK Liverpool Cancer Trials Unit
      • London, England, United Kingdom, SE1 7EH
        • St. Thomas' Hospital
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital NHS Trust
      • Merseyside, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Middlesbrough, Cleveland, England, United Kingdom, TS4 3BW
        • James Cook University Hospital at South Tees Hospitals NHS Trust
      • Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
        • Northern Centre for Cancer Treatment at Newcastle General Hospital
      • Norwich, England, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Plymouth, England, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Poole Dorset, England, United Kingdom, BH15 2JB
        • Poole Hospital NHS Trust
      • Prescot Merseyside, England, United Kingdom, L35 5DR
        • Whiston Hospital
      • Preston, England, United Kingdom, PR2 9HT
        • Royal Preston Hospital
      • Salisbury, England, United Kingdom, SP2 8BJ
        • Salisbury District Hospital
      • Southampton, England, United Kingdom, SO14 0YG
        • Royal South Hants Hospital
      • Stoke-On-Trent, England, United Kingdom, ST4 7LN
        • University Hospital of North Staffordshire
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden NHS Foundation Trust - Surrey
      • Warrington, England, United Kingdom, WA5 1QG
        • Warrington Hospital NHS Trust
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
    • Wales
      • Swansea, Wales, United Kingdom, SA2 8QA
        • Singleton Hospital of the Swansea NHS Trust

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • WHO 0-2

Life expectancy:

  • More than 3 months

Hematopoietic:

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

Hepatic:

  • Bilirubin less than 2 mg/dL

Renal:

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

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

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

Endocrine therapy:

  • Not specified

Radiotherapy:

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

Surgery:

  • See Disease Characteristics

Other:

  • 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)

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival at 1 year

Secondary Outcome Measures

Outcome Measure
Toxicity
Quality of life
Objective response rate
Median survival rate
Survival rate at 2 years

Collaborators and Investigators

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

Sponsor

Cancer Research UK

Investigators

  • Emily Owen, Cancer Research UK

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

April 1, 2002

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

March 8, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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