Chemotherapy With FOLFIRI Plus Bevacizumab (AvastinR) in Patients With Metastatic Colorectal Cancer Bearing Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/UGT1A1*1/UGT1A1*28: Prospective, Phase II, Multicenter Study
18 Years
74 Years
Both
Colorectal Cancer
Trial Information
Chemotherapy With FOLFIRI Plus Bevacizumab (AvastinR) in Patients With Metastatic Colorectal Cancer Bearing Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/UGT1A1*1/UGT1A1*28: Prospective, Phase II, Multicenter Study
OBJECTIVES:
Primary
- Evaluate the objective response (RECIST criteria) at 6 months associated with FOLFIRI
and bevacizumab therapy.
- Evaluate the tolerability (NCI CTC v. 2.0 criteria) of this treatment.
Secondary
- Evaluate progression-free survival and overall survival.
- Determine the time to treatment failure.
- Evaluate the quality of life (EuroQOL EQ5D questionnaire).
- Explore the prognostic factors associated with the tolerability and efficacy of this
treatment.
OUTLINE: This is a multicenter study. Patients are stratified according to genotype
(UCT1A1*1/ UCT1A1*1 vs UCT1A1*1/ UCT1A1*28).
Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90
minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.
Treatment repeats every 2 weeks in the absence of disease progression or unacceptable
toxicity.
Quality of life is assessed at baseline, every 4 courses, and then every 2 months after the
completion of study therapy.
After completion of study therapy, patients are followed every 2-3 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of metastatic adenocarcinoma of the colon or rectum
- Not curable by surgery
- Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/ UGT1A1*28
- Measurable disease
- No original tumor in place
- No secondary cerebral metastases
PATIENT CHARACTERISTICS:
Inclusion criteria:
- WHO performance status 0-2
- Life expectancy ≥ 3 months
- Absolute neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 times normal
- Alkaline phosphatase ≤ 2.5 times normal (5 times normal if liver involvement)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients of must use effective contraception
Exclusion criteria:
- Progressive gastrointestinal ulcer, hemorrhagic ulcer, or perforation in the past 6
months
- Enteropathy or chronic diarrhea
- Proteinuria > 500 mg/24 hours
- Active cardiac disease
- Uncontrolled hypertension
- Myocardial infarction in the past 12 months
- Angina
- NYHA grade II-IV congestive heart disease
- Severe arrhythmia even with treatment
- Peripheral vascular disease ≥ grade II
- Nonhealing wound, ulcer, or severe bone fracture
- Hemorrhagic diatheses or coagulopathy
- Severe or uncontrolled infection
- Severe or uncontrolled medical condition
- Other malignant disease in the past 5 years except curatively treated basal cell skin
cancer or carcinoma in situ of the uterine cervix
- Severe traumatic injury within the past 4 weeks
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy for metastatic disease
- One prior regimen of chemotherapy in the neoadjuvant or adjuvant setting for the
original tumor allowed
- At least 6 months since prior chemotherapy
- No prior irinotecan hydrochloride or bevacizumab
- No oral or parenteral anticoagulant therapy within the past 10 days
- Warfarin allowed provided INR < 1.5
- No major surgery or biopsy within the past 4 weeks
- No puncture in the past 7 days
- No planned major surgery
- No concurrent daily or chronic aspirin (> 325 mg/day), anti-inflammatories, or
steroids
- No other concurrent anticancer therapy
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response at 6 months by RECIST
Safety Issue:
No
Principal Investigator
Martina Schneider
Investigator Role:
Study Chair
Investigator Affiliation:
Federation Francophone de Cancerologie Digestive
Authority:
Unspecified
Study ID:
CDR0000564065
NCT ID:
NCT00628810
Start Date:
January 2007
Completion Date:
Related Keywords:
- Colorectal Cancer
- adenocarcinoma of the colon
- adenocarcinoma of the rectum
- stage IV colon cancer
- stage IV rectal cancer
- recurrent colon cancer
- recurrent rectal cancer
- Colorectal Neoplasms
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