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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
FOLFOX regimen
fluorouracil
leucovorin calcium
oxaliplatin
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: ECOG 0-2 WHO 0-2 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Alkaline phosphatase less than 5 times upper limit of normal (ULN) Renal: Creatinine less than 3 times ULN No uncontrolled hypercalcemia Cardiovascular: No uncontrolled congestive heart failure, angina pectoris, hypertension, or arrhythmias Other: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for metastatic disease Chemotherapy: 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 Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: Concurrent surgery allowed Other: At least 30 days since other prior investigational drugs No other concurrent investigational treatment No other concurrent antitumoral treatment

Sites / Locations

  • Hopital Saint Antoine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 6, 2000
Last Updated
January 10, 2009
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00006468
Brief Title
Comparing Two Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
Official Title
Phase III Study of An Optimized LV-5FU-Oxaliplatin Regimen in Metastatic Colorectal Cancer. C99-1.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2000
Overall Recruitment Status
Unknown status
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FOLFOX regimen
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
oxaliplatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: ECOG 0-2 WHO 0-2 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Alkaline phosphatase less than 5 times upper limit of normal (ULN) Renal: Creatinine less than 3 times ULN No uncontrolled hypercalcemia Cardiovascular: No uncontrolled congestive heart failure, angina pectoris, hypertension, or arrhythmias Other: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for metastatic disease Chemotherapy: 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 Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: Concurrent surgery allowed Other: At least 30 days since other prior investigational drugs No other concurrent investigational treatment No other concurrent antitumoral treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimery de Gramont, MD
Organizational Affiliation
Hopital Saint Antoine
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France

12. IPD Sharing Statement

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

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