Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer
18 Years
80 Years
Both
Colorectal Cancer
Trial Information
Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression
Safety Issue:
No
Principal Investigator
May Mabro, MD
Investigator Affiliation:
Hopital Foch
Authority:
United States: Federal Government
Study ID:
CDR0000347378
NCT ID:
NCT00075595
Start Date:
June 2002
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage IV colon cancer
- stage IV rectal cancer
- recurrent colon cancer
- recurrent rectal cancer
- adenocarcinoma of the colon
- adenocarcinoma of the rectum
- Colorectal Neoplasms
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