Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005964
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2000-07-05
Brief Title:
Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Previously Untreated Aggressive Stage II Stage III or Stage IV Non-Hodgkins Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Randomized Phase II Study of Dose-Adjusted EPOCH vs NHL-15 Chemotherapy for Patients With Previously Untreated Aggressive Non-Hodgkins Lymphoma NHL
Status:
COMPLETED
Status Verified Date:
2016-07
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one chemotherapy drug may kill more tumor cells It is not yet known which combination chemotherapy regimen is most effective in treating aggressive non-Hodgkins lymphoma
PURPOSE Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have previously untreated aggressive stage II stage III or stage IV non-Hodgkins lymphoma
PURPOSE Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have previously untreated aggressive stage II stage III or stage IV non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the response rates in patients with previously untreated aggressive non-Hodgkins lymphoma treated with doxorubicin etoposide vincristine cyclophosphamide and prednisone EPOCH II Determine the toxic effects of this regimen in these patients
OUTLINE This is a multicenter study Patients receive doxorubicin IV etoposide IV vincristine IV and cyclophosphamide IV continuously over days 1-4 Patients also receive oral prednisone twice daily on days 1-5 and filgrastim G-CSF subcutaneously beginning on day 6 until blood counts recover Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years and then every 6 months for 3 years
OUTLINE This is a multicenter study Patients receive doxorubicin IV etoposide IV vincristine IV and cyclophosphamide IV continuously over days 1-4 Patients also receive oral prednisone twice daily on days 1-5 and filgrastim G-CSF subcutaneously beginning on day 6 until blood counts recover Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 2 years and then every 6 months 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 |
|---|---|---|---|
| CDR0000067947 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-C59910 | None | None | None |