Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109928
Status:
COMPLETED
Last Update Posted:
2014-10-01
First Post:
2005-05-03
Brief Title:
S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II Stage III or Stage IV Peripheral T-Cell Non-Hodgkins Lymphoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol PEGS in Peripheral T-Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2014-09
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 such as cisplatin etoposide gemcitabine and methylprednisolone 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
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage II stage III or stage IV T-cell non-Hodgkins lymphoma
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage II stage III or stage IV T-cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine 2-year overall survival of patients with newly diagnosed bulky stage II or stage III or IV peripheral T-cell non-Hodgkins lymphoma treated with cisplatin etoposide gemcitabine and methylprednisolone
Secondary
Determine the toxicity of this regimen in these patients
Determine the response rate complete unconfirmed response complete response and partial response in patients treated with this regimen
Determine progression-free survival of patients treated with this regimen
OUTLINE This is a pilot multicenter study
Patients receive cisplatin IV over 30-60 minutes etoposide IV over 30-60 minutes and methylprednisolone IV over 5 minutes on days 1-4 Patients also receive gemcitabine IV over 30-60 minutes on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 3-6 weeks 3 months and then every 6 months for up to 3 years
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study within 3 years
Primary
Determine 2-year overall survival of patients with newly diagnosed bulky stage II or stage III or IV peripheral T-cell non-Hodgkins lymphoma treated with cisplatin etoposide gemcitabine and methylprednisolone
Secondary
Determine the toxicity of this regimen in these patients
Determine the response rate complete unconfirmed response complete response and partial response in patients treated with this regimen
Determine progression-free survival of patients treated with this regimen
OUTLINE This is a pilot multicenter study
Patients receive cisplatin IV over 30-60 minutes etoposide IV over 30-60 minutes and methylprednisolone IV over 5 minutes on days 1-4 Patients also receive gemcitabine IV over 30-60 minutes on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 3-6 weeks 3 months and then every 6 months for up to 3 years
PROJECTED ACCRUAL A total of 55 patients will be accrued for this study within 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 |
|---|---|---|---|
| S0350 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |