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

GERCOR - Multidisciplinary Oncology Cooperative Group

Status and phase

Unknown

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: FOLFIRI regimen

Drug: leucovorin calcium

Drug: irinotecan hydrochloride

Drug: fluorouracil

Study type

Interventional

Funder types

Other

Identifiers

NCT00075595

FRE-GERCOR-FOLFIRI3-C00-2

EU-20333

CDR0000347378

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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