Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00428142
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2007-01-25
Brief Title:
Bortezomib Combination Chemotherapy and Rituximab as First-Line Therapy in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkins Lymphoma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
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-Hodgkins Lymphoma Requiring Systemic First-Line Treatment
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-Hodgkins lymphoma
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-Hodgkins 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-Hodgkins 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
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-Hodgkins 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000527275 | OTHER | PDQ | None |
| CAN-NCIC-LY13 | None | None | None |