Colorectal Cancer
Conditions
Keywords
stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, chemotherapy
Brief summary
PURPOSE: This randomized phase III trial is studying maintenance therapy with bevacizumab alone after an induction therapy combining bevacizumab+chemotherapy to see how well they work compared to maintenance therapy with bevacizumab+erlotinib alone after an induction therapy combining bevacizumab+chemotherapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.
Detailed description
OBJECTIVES: Primary * Compare Progression-free survival during maintenance period (Maintenance PFS)in patients with unresectable metastatic colorectal cancer. Secondary * Compare the duration of disease control 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. * Compare the occurrence of secondary surgery in patients treated with these regimens. * Compare the chemotherapy-free intervals and response rates in patients treated with these regimens. INDUCTION THERAPY Bevacizumab IV over 30-90 minutes on day 1, combined with either: * modified FOLFOX7 (IV : oxaliplatin, folinic acid, fluorouracil), * XELOX2 (IV : oxaliplatin, oral capecitabine day 1 to 8), * FOLFIRI (IV : irinotecan, folinic acid, fluorouracil). Treatment repeats every 2 weeks. RANDOMIZATION Patients with stable or responding disease then receive maintenance therapy with bevacizumab alone or bevacizumab+erlotinib MAINTENANCE THERAPY * Arm A : bevacizumab alone : bevacizumab IV over 30-90 minutes on day 1 * Arm B : bevacizumab+erlotinib : bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib once daily on days 1-21. In both arms, treatment with bevacizumab +/- erlotinib repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. ACCRUAL: A total of 700 patients will be accrued for this study.
Interventions
DRUGbevacizumab
bevacizumab 7.5mg/kg every 3 weeks until disease progression or limiting toxicity
bevacizumab 7.5mg/kg and oral erlotinib 150 mg/day continuously Cycles every 3 weeks until disease progression or limiting toxicity
Sponsors
GERCOR - Multidisciplinary Oncology Cooperative Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
MAIN ELIGIBILITY CRITERIA * Histologically proven metastatic adenocarcinoma of colon or rectum * Documented inoperable disease (i.e., not suitable for complete carcinological surgical resection) * Measurable lesion as assessed by CT scan or MRI in at least one dimension (longest diameter to be recorded) ≥ 20 mm with conventional CT scan or ≥ 10 mm with spiral CT scan * No previous therapy for metastatic disease * No history or evidence upon physical examination of CNS disease (e.g., non-irradiated CNS metastasis, seizure not controlled with standard medical therapy, or history of stroke) unless adequately treated * No exclusive bone metastasis * ECOG performance status 0-2 * WBC ≥ 1,500/mm\^3 * Platelets ≥ 100,000/mm\^3 * Hemoglobin \> 9 g/dL (may be transfused to maintain or exceed this level) * Proteinuria \< 2+ by dipstick OR ≤ 1 g of protein on 24-hr urine collection * Bilirubin \< 1.5 times ULN * Alkaline phosphatase \< 3 times ULN * No peripheral sensory neuropathy * Negative pregnancy test * Fertile patients must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterilization) * No peripheral neuropathy ≥ grade 1 * No clinically significant (i.e. active) cardiovascular disease * No evidence of bleeding diathesis or coagulopathy * No serious, non-healing wound, ulcer, or bone fracture * No significant ophthalmologic abnormality * More than 28 days since prior major surgical procedure or open biopsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival during maintenance therapy | Tumor evaluation every 2 months |
Countries
Austria, Canada, France
Outcome results
None listed