Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral T-Cell Non-Hodgkin's Lymphoma
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-Hodgkin's lymphoma.
Drug: gemcitabine hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma|
- Overall survival at 2 years [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Response rate (complete unconfirmed, complete, and partial) [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
- Determine 2-year overall survival of patients with newly diagnosed, bulky stage II or stage III or IV peripheral T-cell non-Hodgkin's lymphoma treated with cisplatin, etoposide, gemcitabine, and methylprednisolone.
- 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.