Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer
75 Years
N/A
Both
Colorectal Cancer
Trial Information
Randomized Study of Second-Line Therapy Comprising Irinotecan With or Without Capecitabine in Patients Aged At Least 75 Years With Colorectal Cancer
OBJECTIVES:
Primary
- Compare the objective response or stable disease rate in elderly patients with
unresectable, progressive, metastatic colorectal cancer treated with irinotecan
hydrochloride with vs without capecitabine.
Secondary
- Compare the tolerability of these regimens in these patients.
- Compare the quality of life and ability to maintain self-sufficiency of patients
treated with these regimens.
- Compare the progression-free and overall survival of patients treated with these
regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified
according to participating center, WHO performance status (0 or 1 vs 2), number of
associated comorbidities (Charlson index 0-2 vs > 2), and age (75-79 vs ≥ 80). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment
repeats every 2 weeks for 2 courses in the absence of disease progression or
unacceptable toxicity.
- Arm II: Patients receive oral capecitabine on days 1-14 and irinotecan hydrochloride IV
over 90 minutes on day 1. Treatment repeats every 3 weeks for 2 courses in the absence
of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 12 weeks thereafter.
After completion of study therapy, patients are followed every 12 weeks.
PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic adenocarcinoma of the colon or rectum
- Unresectable disease
- Documented progressive disease during first-line/palliative chemotherapy
- Measurable disease ≥ 1 cm that is outside prior radiation field
- No brain metastases
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy ≥ 3 months
- No contraindication to chemotherapy
- Creatinine clearance ≥ 40 mL/min
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Alkaline phosphatase ≤ 3 times normal (5 times normal if hepatic involvement)
- Bilirubin ≤ 1.5 times normal
- Transaminases ≤ 5 times normal
- No symptomatic coronary disease or cardiac insufficiency
- No enteropathy or chronic diarrhea
- No unresolved intestinal occlusion or subocclusion
- No history of severe unexpected reaction to a fluoropyrimidine
- No other active malignancy in the past 2 years
- No hypersensitivity to irinotecan hydrochloride or its excipients
- No hypersensitivity to capecitabine or fluorouracil
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior extensive resection
- No concurrent sorivudine or similar analogs (e.g., brivudine)
- No other concurrent anticancer therapy
- Concurrent radiotherapy allowed for nontarget lesions
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response
Safety Issue:
No
Principal Investigator
Emmanuel Mitry, MD, PhD
Investigator Affiliation:
Hopital Ambroise Pare
Authority:
United States: Federal Government
Study ID:
CDR0000453857
NCT ID:
NCT00303745
Start Date:
June 2006
Completion Date:
Related Keywords:
- Colorectal Cancer
- adenocarcinoma of the colon
- recurrent colon cancer
- stage IV colon cancer
- adenocarcinoma of the rectum
- recurrent rectal cancer
- stage IV rectal cancer
- Colorectal Neoplasms
Name | Location |
|---|
