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. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining fluorouracil and leucovorin with irinotecan in treating patients who have recurrent or refractory metastatic unresectable colorectal cancer.

Condition	Treatment or Intervention	Phase
stage IV colon cancer Stage IV rectal cancer recurrent colon cancer recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum	Drug: fluorouracil  Drug: irinotecan  Drug: leucovorin calcium  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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

France
      American Hospital of Paris, Neuilly-sur-Seine,  F-92202,  France; Recruiting
      Centre Hospital Universitaire Hop Huriez, Lille,  59037,  France; Recruiting
      Centre Medico-Chirurgical Foch, Suresnes,  92151,  France; Recruiting
      Clinique Armoricaine De Radiologie, Saint-Brieuc,  F-22015,  France; Recruiting
      Clinique de l'Orangerie, Strasbourg,  67010,  France; Recruiting
      Clinique Saint Jean, Lyon,  69008,  France; Recruiting
      Clinique Ste - Marie, Pontoise,  95300,  France; Recruiting
      Hopital Bichat - Claude Bernard, Paris,  75018,  France; Recruiting
      Hopital Drevon, Dijon,  21000,  France; Recruiting
      Hopital Europeen Georges Pompidou, Paris,  75015,  France; Recruiting
      Hopital Saint Antoine, Paris,  75571,  France; Recruiting
      Hopital Saint Joseph, Marseille,  13008,  France; Recruiting
      Hopital Tenon, Paris,  75970,  France; Recruiting
      Intercommunal Hospital, Montfermeil,  93370,  France; Recruiting
      Polyclinique De Courlancy, Reims,  F-51100,  France; Recruiting

Study chairs or principal investigators

May Mabro, MD,  Centre Medico-Chirurgical Foch   

Study ID Numbers:  CDR0000347378; FRE-GERCOR-FOLFIRI3-C00-2; EU-20333; NCT00075595
Record last reviewed:  December 2003
Last Updated:  December 6, 2004
Record first received:  January 9, 2004
ClinicalTrials.gov Identifier:  NCT00075595
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08