Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217425
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2005-09-20
Brief Title:
Bevacizumab and Combination Chemotherapy in Treating Patients With Peripheral T-Cell Lymphoma or Natural Killer Cell Neoplasms
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Bevacizumab and CHOP A-CHOP in Combination for Patients With Peripheral T-Cell or Natural Killer Cell Neoplasms
Status:
COMPLETED
Status Verified Date:
2023-06
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 Monoclonal antibodies such as 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 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 bevacizumab together with combination chemotherapy may kill more cancer cells
PURPOSE This phase II trial is studying how well giving bevacizumab together with several chemotherapy drugs combination chemotherapy works in treating patients with peripheral T-cell lymphoma or natural killer cell neoplasms
PURPOSE This phase II trial is studying how well giving bevacizumab together with several chemotherapy drugs combination chemotherapy works in treating patients with peripheral T-cell lymphoma or natural killer cell neoplasms
Detailed Description:
OBJECTIVES
Primary
Determine the 12-month progression-free survival of patients with peripheral T-cell or natural killer cell neoplasms treated with bevacizumab and combination chemotherapy comprising cyclophosphamide doxorubicin vincristine and prednisone A-CHOP
Secondary
Determine the overall response rate complete remission CR unconfirmed CR or functional CR and partial remission in these patients after courses 3 6 and 8 of this treatment regimen
Determine the overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive 6-8 cycles of A-CHOP followed by 8 cycles of maintenance bevacizumab MA as outlined below Bevacizumab 15 mgkg is administered on day 1 over 90 min first cycle 60 min second cycle and 30 min for the subsequent cycles CHOP cyclophosphamide 750 mgm 2 doxorubicin 50 mgm 2 vincristine 14 mgm2 max 2 mg prednisone 100 mg daily on days 1-5 is administered on day 1 of a 21-day cycle Radiographic response is assessed after cycles 3 6 and 8 of ACHOP and after cycle 8 of MA Patients receive six cycles of ACHOP if they achieve a complete response CR after three cycles eight cycles if they achieve a partial response PR after three cycles Non-responders are removed from the study ACHOP responders receive maintenance bevacizumab 15 mgkg every 21 days for eight cycles
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for up to 5 years
PROJECTED ACCRUAL A total of 43 patients will be accrued for this study within 22 months
ACTUAL ACCRUAL 46
Primary
Determine the 12-month progression-free survival of patients with peripheral T-cell or natural killer cell neoplasms treated with bevacizumab and combination chemotherapy comprising cyclophosphamide doxorubicin vincristine and prednisone A-CHOP
Secondary
Determine the overall response rate complete remission CR unconfirmed CR or functional CR and partial remission in these patients after courses 3 6 and 8 of this treatment regimen
Determine the overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive 6-8 cycles of A-CHOP followed by 8 cycles of maintenance bevacizumab MA as outlined below Bevacizumab 15 mgkg is administered on day 1 over 90 min first cycle 60 min second cycle and 30 min for the subsequent cycles CHOP cyclophosphamide 750 mgm 2 doxorubicin 50 mgm 2 vincristine 14 mgm2 max 2 mg prednisone 100 mg daily on days 1-5 is administered on day 1 of a 21-day cycle Radiographic response is assessed after cycles 3 6 and 8 of ACHOP and after cycle 8 of MA Patients receive six cycles of ACHOP if they achieve a complete response CR after three cycles eight cycles if they achieve a partial response PR after three cycles Non-responders are removed from the study ACHOP responders receive maintenance bevacizumab 15 mgkg every 21 days for eight cycles
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for up to 5 years
PROJECTED ACCRUAL A total of 43 patients will be accrued for this study within 22 months
ACTUAL ACCRUAL 46
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 |
|---|---|---|---|
| E2404 | OTHER | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |