Comparing Two Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006468
Recruitment Status : Unknown
Verified December 2000 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 13, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for metastatic colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have metastatic colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Phase 3

Detailed Description:


  • Compare the efficacy of intermittent high-dose oxaliplatin in combination with a simplified bimonthly regimen of leucovorin calcium (LV) and fluorouracil (5-FU) vs standard dose oxaliplatin in combination with the standard bimonthly regimen of LV and 5-FU in patients with metastatic colorectal cancer.
  • Determine the time to treatment failure, tolerance, response rate, and overall survival in patients treated with these 2 regimens.
  • Compare quality of life of these patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to treatment center, performance status (0-1 vs 2), and number of metastatic sites (1 vs more than 1). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive oxaliplatin IV over 2 hours on day 1, and leucovorin calcium IV over 2 hours followed by fluorouracil (5-FU) IV over 22 hours on days 1 and 2.
  • Arm II: Patients receive oxaliplatin IV and leucovorin calcium IV over 2 hours followed by 5-FU IV over 46 hours beginning on day 1 for courses 1-6 and 19-24. For courses 7-18, patients receive leucovorin calcium IV followed by 5-FU IV as above beginning on day 1.

Courses repeat every 14 days in both arms in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, after courses 4 and 6, and every 6 courses thereafter.

Patients are followed monthly for 3 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 460 patients (230 per treatment arm) will be accrued for this study within 18 months.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study of An Optimized LV-5FU-Oxaliplatin Regimen in Metastatic Colorectal Cancer. C99-1.
Study Start Date : January 2000

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed unresectable metastatic adenocarcinoma of the colon or rectum
  • Bidimensionally measurable or evaluable disease outside previously irradiated area

    • No bone metastasis as target lesion
    • At least 1 cm if spiral CT scan OR
    • At least 2 cm if conventional CT scan
  • No CNS metastasis
  • No symptomatic ascites or pleural effusion that is not evacuated
  • No total or partial bowel obstruction



  • 18 to 80

Performance status:

  • ECOG 0-2
  • WHO 0-2

Life expectancy:

  • Not specified


  • Neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3


  • Alkaline phosphatase less than 5 times upper limit of normal (ULN)


  • Creatinine less than 3 times ULN
  • No uncontrolled hypercalcemia


  • No uncontrolled congestive heart failure, angina pectoris, hypertension, or arrhythmias


  • No peripheral sensory neuropathy
  • No prior significant neurologic or psychiatric disorders
  • No other malignancy within past 5 years except adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma
  • No active infection
  • No other concurrent serious disease
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • No prior immunotherapy for metastatic disease


  • Prior adjuvant chemotherapy allowed, provided progression-free interval of more than 6 months since end of last course
  • No prior oxaliplatin or irinotecan
  • No prior chemotherapy for metastatic disease
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • No concurrent radiotherapy


  • Concurrent surgery allowed


  • At least 30 days since other prior investigational drugs
  • No other concurrent investigational treatment
  • No other concurrent antitumoral treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006468

Hopital Saint Antoine
Paris, France, 75571
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Study Chair: Aimery de Gramont, MD Hopital Saint Antoine Identifier: NCT00006468     History of Changes
Other Study ID Numbers: CDR0000068282
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 13, 2009
Last Verified: December 2000

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents