NCT00428142

Bortezomib, Combination Chemotherapy, and Rituximab as First-Line Therapy in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkin's Lymphoma

A Multi-Centre Phase II Trial Investigating the Efficacy and Tolerability of Bortezomib Added to Cyclophosphamide, Vincristine, Prednisone, and Rituximab (BCVP-R) for Patients With Advanced Stage Follicular Non-Hodgkin's Lymphoma Requiring Systemic First-Line Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, 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. Giving bortezomib together with combination chemotherapy and rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving bortezomib together with combination chemotherapy and rituximab works when given as first-line therapy in treating patients with stage III or stage IV follicular non-Hodgkin's lymphoma.

Detailed description

OBJECTIVES: Primary * Assess the efficacy of systemic first-line treatment comprising bortezomib, cyclophosphamide, vincristine, prednisone, and rituximab, in terms of complete response rate, in patients with stage III or IV follicular non-Hodgkin's lymphoma. * Assess the incidence of severe neurotoxicity (defined as grade 3 or 4 neuropathy or neuropathic pain during the first 4 courses of treatment) in patients treated with this regimen. Secondary * Assess the overall response rate and response duration in patients treated with this regimen. * Determine progression-free and overall survival of patients treated with this regimen. * Evaluate the tolerability and characterize the toxicity profile of this regimen in these patients. * Assess quality of life, with particular focus on neurotoxicity-related changes, of patients treated with this regimen. OUTLINE: This is a multicenter, nonrandomized, open-label study. Patient receive cyclophosphamide IV over 15-45 minutes, vincristine IV over 3-5 seconds and rituximab IV over 1½-6 hours on day 1, oral prednisone daily on days 1-5, and bortezomib IV over 3-5 seconds on days 1 and 8. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at the end of each course of treatment, and on day 42 at the post treatment visit. After completion of study treatment, patients are followed at 3 and 6 weeks and then every 3-6 months thereafter. PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab	375mg/m2 day 1
DRUG	bortezomib	1.3mg/m2 days 1 \& 8
DRUG	cyclophosphamide	750mg/m2 day 1
DRUG	prednisone	40mg/m2 days 1-5
DRUG	vincristine sulfate	1.4mg/m2 day 1 (dose capped at 2mg)

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-04-01
• Completion: 2012-01-06
• First posted: 2007-01-29
• Last updated: 2026-03-27

Locations

19 sites across 1 country: Canada