Stage IV Adult Diffuse Large Cell Lymphoma Clinical Trial
Official title:
Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL
This phase II trial is studying how well giving combination chemotherapy together with rituximab and bevacizumab works in treating older patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma. 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 more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as rituximab and 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. Giving combination chemotherapy together with monoclonal antibodies may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To estimate the 1-year progression-free survival rate in patients with advanced stage
diffuse large B-cell NHL treated with CHOP - rituximab - bevacizumab.
II. To estimate the response rate (complete, complete unconfirmed, and partial) and 2-year
progression-free survival of this regimen in patients with advanced stage diffuse large
B-cell NHL.
III. To evaluate the toxicities associated with this regimen. IV. To correlate angiogenic
biomarkers with patient outcome.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV, 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 8 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at least every 6 months for 2
years and then annually for 3 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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