Bortezomib, Combination Chemotherapy, and Rituximab as First-Line Therapy in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: rituximab
- Registration Number
- NCT00428142
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bortezomib + BCVP-R rituximab BCVP-R - q 21 days x 4 cycles Bortezomib: 1.3 mg/m2 Days 1 \& 8 Cyclophosphamide: 750 mg/m2 IV Day 1 Vincristine: 1.4 mg/m2 IV Day 1 (dose capped at 2 mg) Prednisone: 40 mg/m2 po Days 1-5 Rituximab: 375 mg/m2 IV Day 1 Bortezomib + BCVP-R vincristine sulfate BCVP-R - q 21 days x 4 cycles Bortezomib: 1.3 mg/m2 Days 1 \& 8 Cyclophosphamide: 750 mg/m2 IV Day 1 Vincristine: 1.4 mg/m2 IV Day 1 (dose capped at 2 mg) Prednisone: 40 mg/m2 po Days 1-5 Rituximab: 375 mg/m2 IV Day 1 Bortezomib + BCVP-R bortezomib BCVP-R - q 21 days x 4 cycles Bortezomib: 1.3 mg/m2 Days 1 \& 8 Cyclophosphamide: 750 mg/m2 IV Day 1 Vincristine: 1.4 mg/m2 IV Day 1 (dose capped at 2 mg) Prednisone: 40 mg/m2 po Days 1-5 Rituximab: 375 mg/m2 IV Day 1 Bortezomib + BCVP-R prednisone BCVP-R - q 21 days x 4 cycles Bortezomib: 1.3 mg/m2 Days 1 \& 8 Cyclophosphamide: 750 mg/m2 IV Day 1 Vincristine: 1.4 mg/m2 IV Day 1 (dose capped at 2 mg) Prednisone: 40 mg/m2 po Days 1-5 Rituximab: 375 mg/m2 IV Day 1 Bortezomib + BCVP-R cyclophosphamide BCVP-R - q 21 days x 4 cycles Bortezomib: 1.3 mg/m2 Days 1 \& 8 Cyclophosphamide: 750 mg/m2 IV Day 1 Vincristine: 1.4 mg/m2 IV Day 1 (dose capped at 2 mg) Prednisone: 40 mg/m2 po Days 1-5 Rituximab: 375 mg/m2 IV Day 1
- Primary Outcome Measures
Name Time Method Incidence of severe grade 3 or 4 neurotoxicity or neuropathic pain during the first 4 courses of treatment 5 years Complete response rate 5 years
- Secondary Outcome Measures
Name Time Method Response duration in patients with observed responses 5 years Time to progression 5 years Toxicity 5 years Overall response rate 5 years Overall survival 5 years Quality of life 5 years
Trial Locations
- Locations (19)
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
BCCA - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
BCCA - Vancouver Island Cancer Centre
🇨🇦Victoria, British Columbia, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
The Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
QEII Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Credit Valley Hospital
🇨🇦Mississauga, Ontario, Canada
Regional Cancer Program of the Hopital Regional
🇨🇦Sudbury, Ontario, Canada
Scroll for more (9 remaining)Cross Cancer Institute🇨🇦Edmonton, Alberta, Canada