NCT00121199

Combination Chemo, Rituximab, and Bevacizumab in Older Patients With Stage II-IV Diffuse Large B-Cell Lymphoma

Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Contiguous Stage II Adult Diffuse Large Cell Lymphoma
• Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
• Stage III Adult Diffuse Large Cell Lymphoma
• Stage IV Adult Diffuse Large Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab	Given IV
BIOLOGICAL	bevacizumab	Given IV
DRUG	cyclophosphamide	Given IV
DRUG	doxorubicin hydrochloride	Given IV
DRUG	vincristine sulfate	Given IV
DRUG	prednisone	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2005-06-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2005-07-21
• Last updated: 2014-05-21
• Results posted: 2012-12-19

Locations

1 site across 1 country: United States