Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- cisplatin
- Conditions
- Lymphoma
- Sponsor
- SWOG Cancer Research Network
- Enrollment
- 34
- Locations
- 76
- Primary Endpoint
- 2-year Overall Survival Rate
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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-Hodgkin's 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-Hodgkin's 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
PEGS Treatment
VP-16 (Etoposide) 40 mg/m2 IV Days 1-4 Methyl Prednisolone 250 mg IV Days 1-4 Cisplatin 25 mg/m2 IV Days 1-4 Gemcitabine 1,000 mg/m2 IV Day 1
Intervention: cisplatin
PEGS Treatment
VP-16 (Etoposide) 40 mg/m2 IV Days 1-4 Methyl Prednisolone 250 mg IV Days 1-4 Cisplatin 25 mg/m2 IV Days 1-4 Gemcitabine 1,000 mg/m2 IV Day 1
Intervention: etoposide
PEGS Treatment
VP-16 (Etoposide) 40 mg/m2 IV Days 1-4 Methyl Prednisolone 250 mg IV Days 1-4 Cisplatin 25 mg/m2 IV Days 1-4 Gemcitabine 1,000 mg/m2 IV Day 1
Intervention: gemcitabine
PEGS Treatment
VP-16 (Etoposide) 40 mg/m2 IV Days 1-4 Methyl Prednisolone 250 mg IV Days 1-4 Cisplatin 25 mg/m2 IV Days 1-4 Gemcitabine 1,000 mg/m2 IV Day 1
Intervention: methylprednisolone
Outcomes
Primary Outcomes
2-year Overall Survival Rate
Time Frame: 0-2 years
The overall survival rate is the percentage of patients who are alive 2 years after registration to the study. Overall survival is defined as the time between study registration and death due to any cause.
Secondary Outcomes
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug(up to 18 weeks of protocol treatment)
- 2-year Progression-free Survival Rate(0-2 years)
- Response Rate(up to 3 years or time of disease progression)