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Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
FOLFIRI regimen
fluorouracil
irinotecan hydrochloride
leucovorin calcium
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 colorectal adenocarcinoma Metastatic, unresectable disease Meets 1 of the following criteria: At least 1 unidimensionally measurable metastatic lesion at least 10 mm by spiral scan OR 20 mm by conventional scan Evaluable disease Evidence of disease (e.g., ascites or bone metastases) by imaging techniques Progressive disease as defined by 1 of the following criteria: Progressive disease while receiving first-line chemotherapy Recurrent disease within 6 months after completing adjuvant chemotherapy No symptomatic brain metastases PATIENT CHARACTERISTICS: Age 18 to 80 Performance status WHO 0-2 Life expectancy At least 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin < 1.5 times upper limit of normal (ULN) Alkaline phosphatase < 3 times ULN Renal Not specified Cardiovascular No uncontrolled angina No myocardial infarction within the past 6 months Gastrointestinal No chronic diarrhea grade 2 or greater No unresolved fully or partially obstructed intestine Other Not pregnant or nursing Fertile patients must use effective contraception No other underlying disease or medical condition that would preclude study participation No other prior malignancy except curatively treated basal cell cancer or carcinoma in situ of the cervix No psychological, social, familial, or geographical condition that would preclude study follow-up PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics No prior irinotecan Endocrine therapy Not specified Radiotherapy At least 3 weeks since prior radiotherapy Surgery At least 3 weeks since prior surgery Other No other concurrent clinical trial participation

Sites / Locations

  • Hopital Drevon
  • Centre Hospital Universitaire Hop Huriez
  • Clinique Saint Jean
  • Hopital Saint Joseph
  • Intercommunal Hospital
  • American Hospital of Paris
  • Hopital Europeen Georges Pompidou
  • Hopital Bichat - Claude Bernard
  • Hopital Saint Antoine
  • Hopital Tenon
  • Clinique Ste - Marie
  • Polyclinique De Courlancy
  • Clinique Armoricaine De Radiologie
  • Clinique de l'Orangerie
  • Centre Medico-Chirurgical Foch

Outcomes

Primary Outcome Measures

Time to progression
Time to death from progression

Secondary Outcome Measures

Objective response
Stabilization rate
Time to treatment failure
Duration of response
Overall survival rate
Incidence of grade 3 or 4 toxicity

Full Information

First Posted
January 9, 2004
Last Updated
January 3, 2009
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00075595
Brief Title
Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
Official Title
Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2002 (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, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.
Detailed Description
OBJECTIVES: Primary Determine the time to progression and time to death from progression in patients with recurrent or refractory metastatic unresectable colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan. Secondary Determine the objective response and stabilization rate in patients treated with this regimen. Determine the time to treatment failure in patients treated with this regimen. Determine the duration of response in patients treated with this regimen. Determine overall survival rate in patients treated with this regimen. Determine the incidence of grade 3 or 4 toxicity in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive leucovorin calcium IV over 2 hours on day 1, irinotecan IV over 1 hour on days 1 and 3, and fluorouracil IV continuously over 46 hours beginning on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 78 patients 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 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FOLFIRI regimen
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Primary Outcome Measure Information:
Title
Time to progression
Title
Time to death from progression
Secondary Outcome Measure Information:
Title
Objective response
Title
Stabilization rate
Title
Time to treatment failure
Title
Duration of response
Title
Overall survival rate
Title
Incidence of grade 3 or 4 toxicity

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 colorectal adenocarcinoma Metastatic, unresectable disease Meets 1 of the following criteria: At least 1 unidimensionally measurable metastatic lesion at least 10 mm by spiral scan OR 20 mm by conventional scan Evaluable disease Evidence of disease (e.g., ascites or bone metastases) by imaging techniques Progressive disease as defined by 1 of the following criteria: Progressive disease while receiving first-line chemotherapy Recurrent disease within 6 months after completing adjuvant chemotherapy No symptomatic brain metastases PATIENT CHARACTERISTICS: Age 18 to 80 Performance status WHO 0-2 Life expectancy At least 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin < 1.5 times upper limit of normal (ULN) Alkaline phosphatase < 3 times ULN Renal Not specified Cardiovascular No uncontrolled angina No myocardial infarction within the past 6 months Gastrointestinal No chronic diarrhea grade 2 or greater No unresolved fully or partially obstructed intestine Other Not pregnant or nursing Fertile patients must use effective contraception No other underlying disease or medical condition that would preclude study participation No other prior malignancy except curatively treated basal cell cancer or carcinoma in situ of the cervix No psychological, social, familial, or geographical condition that would preclude study follow-up PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics No prior irinotecan Endocrine therapy Not specified Radiotherapy At least 3 weeks since prior radiotherapy Surgery At least 3 weeks since prior surgery Other No other concurrent clinical trial participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
May Mabro, MD
Organizational Affiliation
Hopital Foch
Facility Information:
Facility Name
Hopital Drevon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Centre Hospital Universitaire Hop Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Clinique Saint Jean
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hopital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Intercommunal Hospital
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
American Hospital of Paris
City
Neuilly Sur Seine
ZIP/Postal Code
F-92202
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
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
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Clinique Ste - Marie
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
Polyclinique De Courlancy
City
Reims
ZIP/Postal Code
F-51100
Country
France
Facility Name
Clinique Armoricaine De Radiologie
City
Saint Brieuc
ZIP/Postal Code
F-22015
Country
France
Facility Name
Clinique de l'Orangerie
City
Strasbourg
ZIP/Postal Code
67010
Country
France
Facility Name
Centre Medico-Chirurgical Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France

12. IPD Sharing Statement

Learn more about this trial

Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer

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