Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 to 80 Other FRE-GERCOR-FOLFIRI3-C00-2 EU-20333, NCT00075595

Objectives

Primary

1. 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

1. Determine the objective response and stabilization rate in patients treated with this regimen.
2. Determine the time to treatment failure in patients treated with this regimen.
3. Determine the duration of response in patients treated with this regimen.
4. Determine overall survival rate in patients treated with this regimen.
5. Determine the incidence of grade 3 or 4 toxicity in patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age

• 18 to 80

Performance status

• WHO 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

A total of 78 patients will be accrued for this study within 18 months.

Outcomes

Time to progression
Time to death from progression

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

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.

Trial Contact Information

Trial Lead Organizations

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

May Mabro, MD, Study coordinator		Ph: 33-1-4625-2168 Email: m.mabro@hopital-foch.org

Registry Information
Official Title		Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients with Metastatic, Unresectable, Colorectal Cancer
Trial Start Date		2002-06-01
Registered in ClinicalTrials.gov		NCT00075595
Date Submitted to PDQ		2003-11-24
Information Last Verified		2007-08-07

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