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Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
FOLFIRI regimen
FOLFOX regimen
fluorouracil
irinotecan hydrochloride
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 metastatic adenocarcinoma of the colon or rectum Measurable or evaluable lesion or residual disease (e.g., ascites, bone metastases) Failure after first line therapy Fluorouracil and leucovorin calcium OR Raltitrexed No oxaliplatin or irinotecan Relapse within 6 months of adjuvant therapy Relapse within 6 months of hepatic artery infusion chemotherapy for resected hepatic metastasis No symptomatic brain metastasis PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hepatic: AST and ALT no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Renal: Not specified Other: No bowel obstruction No other significant, uncontrolled underlying medical or psychiatric condition No serious active infection Neurologically stable No other prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix No psychological, social, familial, or geographical condition that would preclude study Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior radiotherapy Surgery: At least 2 weeks since prior surgery Other: No other concurrent experimental drugs

Sites / Locations

  • Hopital Drevon
  • Centre Jean Bernard
  • Centre Hospital Universitaire Hop Huriez
  • Clinique Saint Jean
  • CH Meulan
  • Intercommunal Hospital
  • Centre Hospitalier de Mulhouse
  • American Hospital of Paris
  • Hopital Bichat-Claude Bernard
  • Hopital Saint Antoine
  • CHU Pitie-Salpetriere
  • Hopital Tenon
  • Hopital Claude Gallien
  • Polyclinique De Courlancy
  • C.H. Senlis
  • Clinique de l'Orangerie

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 3, 2000
Last Updated
January 10, 2009
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00006115
Brief Title
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Official Title
Alternation of FOLFOX6 (Oxaliplatin - Leucovorin - Fluorouracil) and FOLFIRI (Irinotecan - Leucovorin - Fluorouracil) as Second Line Treatment of Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2002
Overall Recruitment Status
Unknown status
Study Start Date
April 1999 (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. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer that has not responded to previous chemotherapy.
Detailed Description
OBJECTIVES: I. Determine the efficacy of oxaliplatin, leucovorin calcium, and fluorouracil followed by irinotecan, leucovorin calcium, and fluorouracil in terms of progression free survival in patients with metastatic colorectal cancer. II. Evaluate these treatment regimens in terms of overall survival, response rate, toxicity, and quality of life in this patient population. OUTLINE: This is a multicenter study. Patients receive 4 courses of oxaliplatin IV and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours. Following the initial 4 courses of therapy, patients receive 4 courses of irinotecan IV over 30-90 minutes and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed every 8 weeks. Patients are followed every 3 months until death. PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study over 12 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 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FOLFIRI regimen
Intervention Type
Drug
Intervention Name(s)
FOLFOX regimen
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
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 metastatic adenocarcinoma of the colon or rectum Measurable or evaluable lesion or residual disease (e.g., ascites, bone metastases) Failure after first line therapy Fluorouracil and leucovorin calcium OR Raltitrexed No oxaliplatin or irinotecan Relapse within 6 months of adjuvant therapy Relapse within 6 months of hepatic artery infusion chemotherapy for resected hepatic metastasis No symptomatic brain metastasis PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hepatic: AST and ALT no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Renal: Not specified Other: No bowel obstruction No other significant, uncontrolled underlying medical or psychiatric condition No serious active infection Neurologically stable No other prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix No psychological, social, familial, or geographical condition that would preclude study Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior radiotherapy Surgery: At least 2 weeks since prior surgery Other: No other concurrent experimental drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Hebbar, MD
Organizational Affiliation
Centre Hospital Universitaire Hop Huriez
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Drevon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre Hospital Universitaire Hop Huriez
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Clinique Saint Jean
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
CH Meulan
City
Meulan
ZIP/Postal Code
78250
Country
France
Facility Name
Intercommunal Hospital
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Centre Hospitalier de Mulhouse
City
Mulhouse
ZIP/Postal Code
68051
Country
France
Facility Name
American Hospital of Paris
City
Neuilly Sur Seine
ZIP/Postal Code
F-92202
Country
France
Facility Name
Hopital Bichat-Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
CHU Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Hopital Claude Gallien
City
Quincy Sous Senart
ZIP/Postal Code
91480
Country
France
Facility Name
Polyclinique De Courlancy
City
Reims
ZIP/Postal Code
F-51100
Country
France
Facility Name
C.H. Senlis
City
Senlis
ZIP/Postal Code
60300
Country
France
Facility Name
Clinique de l'Orangerie
City
Strasbourg
ZIP/Postal Code
67010
Country
France

12. IPD Sharing Statement

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Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

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