Combination Chemotherapy and Bevacizumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Colorectal Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Drugs used in chemotherapy, such as oxaliplatin, leucovorin, fluorouracil, and capecitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen with bevacizumab works better in treating colorectal cancer. This randomized phase III trial is studying giving two different combination chemotherapy regimens together with bevacizumab and comparing how well they work in treating patients with locally advanced, metastatic, or recurrent colorectal cancer

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Bevacizumab; Calcium, Dietary; Capecitabine; Fluorouracil; Immunoglobulins; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed locally advanced, recurrent, or metastatic colorectal adenocarcinoma

• Not curable by surgery or amenable to radiotherapy with curative intent

• Previously resected colorectal cancer with new evidence of metastasis does not require separate histologic or cytologic confirmation unless one of the following is true:

• More than 5 years has elapsed between primary surgery and development of metastatic disease

• Primary tumor was T1-T2, N0, M0

• Site of primary lesion must be or have been in the large bowel as determined by endoscopy, radiology, or surgery

• Measurable or evaluable disease

• No known brain or leptomeningeal disease

• Performance status - Zubrod 0-2

• No history of hemorrhagic or thrombotic disorders

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

• Bilirubin no greater than 2.0 times upper limit of normal (ULN)

• SGOT no greater than 2.5 times ULN (5 times ULN for patients with liver involvement)

• Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN for patients with liver involvement or 10 times ULN for patients with bone involvement)

• INR no greater than 1.5

• PTT no greater than ULN

• Creatinine no greater than 1.5 times ULN

• Creatinine clearance at least 50 mL/min

• Proteinuria less than 1+*

• Protein less than 500mg/24 hours*

• No uncontrolled hypertension

• Hypertension must be well-controlled (i.e., less than 160/90) and on a stable regimen of antihypertensive therapy

• No unstable angina

• No symptomatic congestive heart failure

• No myocardial infarction within the past 6 months

• No serious uncontrolled cardiac arrhythmia

• No New York Heart Association class III or IV heart disease

• No symptomatic pulmonary fibrosis

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

• No active or uncontrolled severe infection

• No contraindication to oral medications (e.g., severe dysphagia)

• G-tubes or J-tubes allowed

• No peripheral neuropathy greater than grade 1

• No serious non-healing wound, ulcer, or bone fracture

• No significant traumatic injury within the past 28 days

• No other severe acute or chronic medical condition or laboratory abnormality that would preclude study participation

• No psychiatric condition that would preclude study participation

• No prior bevacizumab

• No prior oxaliplatin

• No prior chemotherapy for advanced colorectal cancer

• Prior adjuvant therapy for resected stage II-III disease allowed provided at least 12 months have elapsed between completion of therapy and diagnosis of recurrent disease

• At least 28 days since prior radiotherapy and recovered

• See Disease Characteristics

• More than 28 days since prior major surgical procedure or open biopsy

• More than 7 days since prior fine needle aspiration or core biopsy

• No concurrent major surgery

• More than 10 days since prior full-dose aspirin (325 mg)

• No concurrent antiplatelet agents (e.g., dipyridamole, ticlopidine, clopidogrel, or cilostazol)

• No other concurrent investigational agents

• No concurrent therapeutic anticoagulation

• Prophylactic anticoagulation of central venous lines allowed

• Low-dose prophylactic enoxaparin or heparin allowed

• No concurrent cimetidine

• No concurrent sorivudine or its related analogs (e.g., brivudine)

• No concurrent use of a cold cap or iced mouth rinses