Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma
18 Years
80 Years
Both
Colorectal Cancer
Trial Information
Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma
OBJECTIVES:
Primary
- Evaluate the objective response (complete and partial) rate in patients with metastatic
colorectal adenocarcinoma treated with bevacizumab and modified FOLFIRI 3 chemotherapy.
Secondary
- Determine progression-free and overall survival.
- Determine the tolerance to this regimen.
- Evaluate the resectability rate.
- Evaluate biological markers predictive of the efficacy of this regimen.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1, irinotecan hydrochloride IV
over 90 minutes on days 1 and 3, and fluorouracil IV continuously over 46 hours on day 1.
Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression
or unacceptable toxicity.
At 14 days after completing chemotherapy, patients with progressive or stable disease
receive maintenance therapy comprising bevacizumab and capecitabine.
Biological specimens are collected at baseline and before the fourth course of chemotherapy.
After completion of study therapy, patients are followed every 3 months for 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the colon or rectum
- Previously untreated metastatic disease
- Measurable disease by RECIST
- Must not be located in a prior radiation field
- No cerebral or meningeal metastases
PATIENT CHARACTERISTICS:
Inclusion criteria:
- WHO performance status 0-1
- Life expectancy > 12 weeks
- Absolute neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Transaminases ≤ 2 times ULN (5 times ULN if liver metastases present)
- Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases present)
- Creatinine ≤ 130 μmol/L OR creatinine clearance ≥ 30 mL/min
- Proteinuria < 2+ or urine protein ≤ 1 g/24 hours
- Not pregnant or nursing
- Fertile patients of must use effective contraception
Exclusion criteria:
- Uncontrolled cardiac disease
- Prior cerebral vascular accident
- Uncontrolled arterial hypertension
- Severe renal or hepatic insufficiency
- Prior arteriopathy
- Bleeding disorder or nonhealing wound
- Coagulopathy
- Other malignancy within the past 2 years except basal cell or squamous cell skin
cancer or curatively treated carcinoma of the cervix
- Psychiatric disorder compromising comprehension or participation in the study
- Intestinal occlusion or subocclusion not caused by medical therapy
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
- See Disease Characteristics
Exclusion criteria:
- Prior adjuvant bevacizumab or irinotecan hydrochloride
- Concurrent aspirin (> 325 mg/day) or therapeutic anticoagulants
- Surgery in the past 28 days
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Objective response (complete and partial) rate
Safety Issue:
No
Principal Investigator
Christophe Borg, PhD
Investigator Affiliation:
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Authority:
Unspecified
Study ID:
CDR0000564118
NCT ID:
NCT00544011
Start Date:
April 2007
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage IV colon cancer
- stage IV rectal cancer
- adenocarcinoma of the colon
- adenocarcinoma of the rectum
- Adenocarcinoma
- Colorectal Neoplasms
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