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Combination Chemotherapy in Treating Patients With Colon Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2002

Sponsored by: Groupe Regional d'Etudes du Cancer Colorectal
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00046995
  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 which schedule of chemotherapy is most effective in treating colon cancer.

PURPOSE: Randomized phase III trial to compare different schedules of chemotherapy using carboplatin with fluorouracil and leucovorin in treating patients who have stage IIB or stage III colon cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: carboplatin
Drug: fluorouracil
Drug: leucovorin calcium
Procedure: adjuvant therapy
Phase III

MedlinePlus related topics:   Cancer    Colorectal Cancer   

ChemIDplus related topics:   Carboplatin    Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Fluorouracil    Calcium gluconate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Active Control
Official Title:   5-Fluorouracil-Leucovorin With or Without Carboplatin as Adjuvant Treatment for Primary Dukes B2-C Colon Cancer; Chronomodulated Versus Standard Administration. A Multicenter Randomized Phase III Trial of the GRECCR-Belgium (Study 03).

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

Primary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]

Estimated Enrollment:   800
Study Start Date:   May 2001

Detailed Description:

OBJECTIVES:

  • Compare the disease-free survival of patients with completely resected stage IIB or III colon cancer treated with adjuvant chronomodulated vs standard schedule fluorouracil and leucovorin calcium with or without carboplatin.
  • Compare the overall survival 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.
  • Determine the dose intensities of fluorouracil and carboplatin in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and disease stage (IIB vs III). Patients are randomized to 1 of 4 treatment arms.

  • Arm I (standard schedule): Patients receive fluorouracil (5-FU) IV continuously and leucovorin calcium (CF) IV on days 1 and 2.
  • Arm II (standard + carboplatin schedule): Patients receive 5-FU and CF as in arm I plus carboplatin IV on day 1.
  • Arm III (chronomodulated schedule): Patients receive 5-FU IV continuously and CF IV continuously on days 1-4.
  • Arm IV (chronomodulated + carboplatin schedule): Patients receive 5-FU and CF as in arm III plus carboplatin IV continuously on days 1-4.

Quality of life is assessed.

Treatment in all arms repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 660-800 patients 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 confirmed adenocarcinoma of the colon

    • Stage IIB or III (Dukes stage B2 or C)
    • Complete curative resection performed within the past 7 weeks (negative margins)
    • No local or regional relapsed disease
  • Tumor more than 15 cm above the anal margin
  • Carcinoembryonic antigen less than 5 ng/mL (after surgery)
  • No rectal cancer
  • No metastatic disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1 OR
  • Karnofsky 60-100%

Life expectancy

  • Not specified

Hematopoietic

  • Neutrophil count at least 2,000/mm3
  • Platelet count at least 100,000/mm3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT no greater than 5 times ULN

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • No serious coronary disease

Other

  • Not pregnant
  • Fertile patients must use effective contraception
  • No concurrent infectious disease
  • No other malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior immunotherapy

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy (before or after surgery)

Surgery

  • See Disease Characteristics

Other

  • No concurrent participation in another clinical trial
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046995

Locations
Belgium
Centre Hospitalier Hutois     Recruiting
      Huy, Belgium, 4500
      Contact: Jean Bury, MD, PhD     32-85-27-21-11     jean.bury@chh.be    
Clinique Saint-Joseph     Recruiting
      Liege, Belgium, B 4000
      Contact: Christian N.J. Focan, MD, PhD     32-4-224-8990     Christian.Focan@CHC.be    

Sponsors and Collaborators
Groupe Regional d'Etudes du Cancer Colorectal

Investigators
Study Chair:     Christian N.J. Focan, MD, PhD     Clinique Saint-Joseph    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000257228, GRECCR-03, EU-20201
First Received:   October 3, 2002
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00046995
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the colon  
stage II colon cancer  
stage III colon cancer  

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Carboplatin
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Adenocarcinoma
Colonic Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on September 05, 2008




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