Bortezomib, Combination Chemotherapy, and Rituximab as First-Line Therapy in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00428142|
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : November 27, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: rituximab Drug: bortezomib Drug: cyclophosphamide Drug: prednisone Drug: vincristine sulfate||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||January 2012|
Experimental: Bortezomib + BCVP-R
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
375mg/m2 day 1
1.3mg/m2 days 1 & 8
750mg/m2 day 1
40mg/m2 days 1-5
Drug: vincristine sulfate
1.4mg/m2 day 1 (dose capped at 2mg)
- Complete response rate [ Time Frame: 5 years ]
- Incidence of severe grade 3 or 4 neurotoxicity or neuropathic pain during the first 4 courses of treatment [ Time Frame: 5 years ]
- Overall response rate [ Time Frame: 5 years ]
- Response duration in patients with observed responses [ Time Frame: 5 years ]
- Time to progression [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 5 years ]
- Toxicity [ Time Frame: 5 years ]
- Quality of life [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428142
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA - Fraser Valley Cancer Centre|
|Surrey, British Columbia, Canada, V3V 1Z2|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|BCCA - Vancouver Island Cancer Centre|
|Victoria, British Columbia, Canada, V8R 6V5|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Canada, New Brunswick|
|The Moncton Hospital|
|Moncton, New Brunswick, Canada, E1C 6Z8|
|Canada, Nova Scotia|
|QEII Health Sciences Center|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Credit Valley Hospital|
|Mississauga, Ontario, Canada, L5M 2N1|
|Regional Cancer Program of the Hopital Regional|
|Sudbury, Ontario, Canada, P3E 5J1|
|Thunder Bay Regional Health Science Centre|
|Thunder Bay, Ontario, Canada, P7B 6V4|
|Odette Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Humber River Regional Hospital|
|Toronto, Ontario, Canada, M9N 1N8|
|Hopital Charles LeMoyne|
|Greenfield Park, Quebec, Canada, J4V 2H1|
|CHUM - Hopital Notre-Dame|
|Montreal, Quebec, Canada, H2L 4M1|
|McGill University - Dept. Oncology|
|Montreal, Quebec, Canada, H2W 1S6|
|CHA-Hopital Du St-Sacrement|
|Quebec City, Quebec, Canada, G1S 4L8|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Study Chair:||Laurie Sehn||British Columbia Cancer Agency|
|Study Chair:||Michael R. Crump, MD, FRCPC||Princess Margaret Hospital, Canada|