Colorectal Cancer
Conditions
Keywords
stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Brief summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well bevacizumab given together with combination chemotherapy works in treating patients with metastatic colorectal cancer.
Detailed description
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.
Interventions
BIOLOGICALbevacizumab
DRUGcapecitabine
DRUGfluorouracil
DRUGirinotecan hydrochloride
OTHERdiagnostic laboratory biomarker analysis
Sponsors
Hopital Jean Minjoz
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response (complete and partial) rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
| Overall survival | — |
| Tolerance | — |
| Resectability rate | — |
| Biomarkers predictive of efficacy | — |
Countries
France
Outcome results
None listed