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Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in 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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Kaiser Permanente - Fremont
Fremont, California, United States
Kaiser Permanente Medical Center - Hayward
Hayward, California, United States
Kaiser Permanente Medical Center - Oakland
Oakland, California, United States
South Sacramento Kaiser-Permanente Medical Center
Sacramento, California, United States
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California, United States
Kaiser Permanente Medical Center - Santa Teresa
San Jose, California, United States
Kaiser Foundation Hospital - San Rafael
San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States
Start Date
September 1, 2005
Primary Completion Date
June 1, 2012
Completion Date
April 1, 2014
Last Updated
October 1, 2014
34
ACTUAL participants
cisplatin
DRUG
etoposide
DRUG
gemcitabine
DRUG
methylprednisolone
DRUG
Lead Sponsor
SWOG Cancer Research Network
Collaborators
NCT05529069
NCT07388563
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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