Colorectal Cancer Clinical Trial
Official title:
Randomized Phase II Trial Evaluating the Feasibility and Tolerance of the Combination of FOLFOX With Cetuximab and the Combination of FOLFOX With Cetuximab and Bevacizumab as Perioperative Treatment in Patients With Resectable Liver Metastases From Colorectal Cancer
Verified date | September 2007 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Monoclonal antibodies, such as cetuximab and 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. Bevacizumab may
also stop the growth of tumor cells by blocking blood flow to the tumor.Drugs used in
chemotherapy, such as leucovorin, oxaliplatin, and fluorouracil, work in different ways to
stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving cetuximab together with combination chemotherapy and bevacizumab before
surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be
removed. Giving these treatments after surgery may kill any tumor cells that remain after
surgery.
PURPOSE: This randomized phase II trial is studying the side effects and how well giving
cetuximab together with leucovorin, oxaliplatin, and fluorouracil works with or without
bevacizumab in treating patients with resectable liver metastases from colorectal cancer.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of metastatic colorectal cancer, meeting all of the following criteria: - Metachronous or synchronous liver metastases - Metastases potentially completely resectable - No requirement for resection combined with cryotherapy or radiofrequency ablation - Must have undergone complete resection (R0) of the primary tumor within the past 4 weeks - Measurable liver metastases - No evidence of extrahepatic disease - 1 or 2 resectable lung metastases allowed PATIENT CHARACTERISTICS: - WHO performance status 0-1 - Absolute neutrophil count > 1,500/mm³ - Platelet count > 100,000/mm³ - Hemoglobin > 9 g/dL - WBC > 3,000/mm³ - Creatinine < 1.5 times upper limit of normal (ULN) - Bilirubin < 1.5 times ULN - AST and ALT < 5 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No significant proteinuria (i.e., protein > 500 mg/24-hour urine collection) - No known allergy to any of the study drugs (including excipients) or any related compound, including hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies - No bleeding diathesis or coagulopathy - No peripheral neuropathy > grade 1 - No serious nonhealing wound, ulcer, or bone fracture - No clinically significant cardiovascular disease, including any of the following: - Uncontrolled hypertension - New York Heart Association class II-IV congestive heart failure - Unstable angina pectoris within the past 12 months - Peripheral vascular disease = grade 2 - Serious cardiac arrhythmia requiring medication - Myocardial infarction within the past 12 months - Cerebrovascular accident or transient ischemic attack within the past 12 months - No symptomatic diverticulitis or known gastroduodenal ulceration - No significant traumatic injury within the past 4 weeks - No known alcohol or drug abuse - No psychological, familial, social, or geographical condition that would preclude study compliance - No other significant disease that would preclude study participation PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior chemotherapy for metastatic disease - At least 1 month since prior major surgical procedure or open biopsy - More than 30 days since prior participation in another clinical study - Prior adjuvant chemotherapy for primary cancer allowed provided the following criteria are met: - At least 12 months since prior oxaliplatin-containing adjuvant therapy - No persistent neuropathy - No prior therapy targeting the epidermal growth factor receptor or vascular endothelial growth factor (VEGF)/VEGF receptor - No concurrent regular use of acetylsalicylic acid (> 325 mg/day) or other nonsteroidal anti-inflammatory drugs - No concurrent full-dose anticoagulation - No concurrent prophylactic hematopoietic growth factors - No concurrent allopurinol |
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hopital Ambroise Pare | Boulogne |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate (preoperative response rate) | No | ||
Primary | Safety (rate of perioperative safety findings) | Yes | ||
Secondary | Progression-free survival | No | ||
Secondary | Pathological resection rate | No | ||
Secondary | Overall survival | No |
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