Randomized Study of Classic vs Simplified Leucovorin Calcium and Fluorouracil With or Without Irinotecan in Patients Aged At Least 75 Years With Advanced Colorectal Cancer
75 Years
N/A
Both
Colorectal Cancer
Trial Information
Randomized Study of Classic vs Simplified Leucovorin Calcium and Fluorouracil With or Without Irinotecan in Patients Aged At Least 75 Years With Advanced Colorectal Cancer
OBJECTIVES:
Primary
- Compare the progression-free survival of elderly patients with unresectable metastatic
colorectal cancer treated with 1 of 2 different chemotherapy regimens comprising
fluorouracil and leucovorin calcium with vs without irinotecan hydrochloride.
Secondary
- Compare the tumor response rate and overall survival of patients treated with these
regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter, prospective study. Patients are stratified
according to participating center, gender, Karnofsky score (60-70% vs 80-90% vs 100%),
associated comorbidities (Charlson Index 0 vs 1-2 vs 3+), age (75 to 79 years vs ≥ 80
years), alkaline phosphatase level (≤ 2 times normal vs > 2 times normal), and prior
adjuvant chemotherapy (yes vs no). Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV
continuously over 22 hours on days 1 and 2.
- Arm II: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV
continuously over 46 hours on days 1 and 2.
- Arm III: Patients receive leucovorin calcium and fluorouracil as in arm I and
irinotecan hydrochloride IV over 90 minutes on day 1.
- Arm IV: Patients receive leucovorin calcium and fluorouracil as in arm II and
irinotecan hydrochloride as in arm III.
In all arms, treatment repeats every 14 days in the absence of disease progression or
unacceptable toxicity.
Patients undergo surgery within 3-10 weeks after completing chemotherapy.
Quality of life is assessed at baseline and then every 2 months thereafter.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 282 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic disease
- Unresectable disease
- Measurable disease that is outside the field of prior irradiation
- No brain metastases
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Transaminases ≤ 5 times normal
- Bilirubin ≤ 1.5 times normal
- Alkaline phosphatase < 3 times normal (5 times normal if due to hepatic involvement)
- Creatinine clearance > 45 mL/min
- Life expectancy > 3 months
- No psychological, social, or geographical situation that would preclude study
treatment
- No chronic diarrhea or enteropathy
- No coronary insufficiency or symptomatic cardiac disease
- No other malignancy unless curatively treated
- No contraindication to chemotherapy
PRIOR CONCURRENT THERAPY:
- At least 6 months since prior adjuvant chemotherapy for the primary tumor
- No prior extensive resection
- No other concurrent anticancer therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Emmanuel Mitry, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Hopital Ambroise Pare
Authority:
Unspecified
Study ID:
CDR0000453855
NCT ID:
NCT00303771
Start Date:
June 2003
Completion Date:
Related Keywords:
- Colorectal Cancer
- adenocarcinoma of the rectum
- stage IV rectal cancer
- stage IV colon cancer
- adenocarcinoma of the colon
- recurrent colon cancer
- recurrent rectal cancer
- Colorectal Neoplasms
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