Bevacizumab and Combination Chemotherapy in Treating Patients With Peripheral T-Cell Lymphoma or Natural Killer Cell Neoplasms
RATIONALE: 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 carry cancer-killing substances to them. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with several chemotherapy drugs (combination chemotherapy) works in treating patients with peripheral T-cell lymphoma or natural killer cell neoplasms.
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Bevacizumab and CHOP (A-CHOP) in Combination for Patients With Peripheral T-Cell or Natural Killer Cell Neoplasms|
- 1 year progression-free survival rate [ Designated as safety issue: No ]
- Overall response rate (complete remission [(CR), unconfirmed CR, or functional CR] and partial remission) after courses 3, 6, and 8 [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||July 2006|
|Estimated Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
- Determine the 12-month progression-free survival of patients with peripheral T-cell or natural killer cell neoplasms treated with bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP).
- Determine the overall response rate (complete remission [(CR), unconfirmed CR, or functional CR] and partial remission) in these patients after courses 3, 6, and 8 of this treatment regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes, cyclophosphamide IV over 15 minutes, doxorubicin IV and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease (SD) after course 3 and remain in SD after course 6 should discontinue treatment. Patients achieving PR after course 3 who then achieve CR, CRu, or functional CR after course 6 and patients achieving SD after course 3 who then achieve PR after course 6 receive 2 additional courses of bevacizumab, cyclophosphamide, doxorubicin, and vincristine in courses 7 and 8. Patients achieving a complete remission (CR) or unconfirmed CR (CRu) after 6 courses or after 8 courses or patients achieving partial response (PR) after 8 courses, then receive bevacizumab alone IV over 30 minutes on day 1. Treatment with bevacizumab alone repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 22 months.
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|Study Chair:||Kristen N. Ganjoo, MD||Veterans Affairs Medical Center - Palo Alto|
|Investigator:||Ranjana Advani, MD||Stanford University|