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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00032175
First received: March 8, 2002
Last updated: June 25, 2013
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: capecitabine
Drug: gemcitabine hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Designated as safety issue: No ]
  • Median survival rate [ Designated as safety issue: No ]
  • Survival rate at 2 years [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Objective response rate [ Designated as safety issue: No ]

Estimated Enrollment: 508
Study Start Date: April 2002
Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032175

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00032175     History of Changes
Other Study ID Numbers: CRUK-GEM-CAP, CDR0000069263, EU-20116, ISRCTN11513444
Study First Received: March 8, 2002
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III pancreatic cancer
duct cell adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 29, 2014