Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121199
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2005-07-19
Brief Title:
Combination Chemo Rituximab and Bevacizumab in Older Patients With Stage II-IV Diffuse Large B-Cell Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Standard Dose Cyclophosphamide Doxorubicin Vincristine Prednisone CHOP and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL
Status:
COMPLETED
Status Verified Date:
2012-12
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:
This phase II trial is studying how well giving combination chemotherapy together with rituximab and bevacizumab works in treating older patients with stage II stage III or stage IV diffuse large B-cell lymphoma 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 more than one drug combination chemotherapy may kill more cancer cells Monoclonal antibodies such as rituximab and 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 Giving combination chemotherapy together with monoclonal antibodies may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the 1-year progression-free survival rate in patients with advanced stage diffuse large B-cell NHL treated with CHOP - rituximab - bevacizumab
II To estimate the response rate complete complete unconfirmed and partial and 2-year progression-free survival of this regimen in patients with advanced stage diffuse large B-cell NHL
III To evaluate the toxicities associated with this regimen IV To correlate angiogenic biomarkers with patient outcome
OUTLINE This is a multicenter study
Patients receive rituximab IV bevacizumab IV over 30-90 minutes cyclophosphamide IV over 15 minutes doxorubicin IV and vincristine IV on day 1 Patients also receive oral prednisone on days 1-5 Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at least every 6 months for 2 years and then annually for 3 years
I To estimate the 1-year progression-free survival rate in patients with advanced stage diffuse large B-cell NHL treated with CHOP - rituximab - bevacizumab
II To estimate the response rate complete complete unconfirmed and partial and 2-year progression-free survival of this regimen in patients with advanced stage diffuse large B-cell NHL
III To evaluate the toxicities associated with this regimen IV To correlate angiogenic biomarkers with patient outcome
OUTLINE This is a multicenter study
Patients receive rituximab IV bevacizumab IV over 30-90 minutes cyclophosphamide IV over 15 minutes doxorubicin IV and vincristine IV on day 1 Patients also receive oral prednisone on days 1-5 Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at least every 6 months for 2 years and then annually for 3 years
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 |
|---|---|---|---|
| U10CA032102 | NIH | CTEP | httpsreporternihgovquickSearchU10CA032102 |
| NCI-2012-03062 | REGISTRY | None | None |
| S0515 | OTHER | None | None |
| S0515 | OTHER | None | None |