Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments cisplatin, etoposide, gemcitabine, methylprednisolone
Phase phase 2
Sponsor Southwest Oncology Group
Collaborator National Cancer Institute (NCI)
Start date September 2005
End date January 2013
Trial size 34 participants
Trial identifier NCT00109928, CDR0000425643, S0350, U10CA032102

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
cisplatin
etoposide
gemcitabine
methylprednisolone

Primary Outcomes

Measure
Overall survival
time frame: 0-2 years

Secondary Outcomes

Measure
Progression-free Survival
time frame: 0-2 years
Toxicity (Number of Patients With Grade 3 Through Grade 5 Adverse Events that are Related to Study Drug)
time frame: up to 18 weeks of protocol treatment
Response Rate
time frame: up to 3 years or time of disease progression

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Diagnosis of peripheral T-cell non-Hodgkin's lymphoma - Newly diagnosed, relapsed or progressing disease after 1 prior treatment with a non-platinum based chemotherapy (e.g., CHOP) - Bulky stage II or stage III or IV disease - The following histologies are not eligible: - T-cell prolymphocytic leukemia - T-cell large granular lymphocytic leukemia - Any NK-cell leukemia - Adult T-cell leukemia/lymphoma - Mycosis fungoides/Sézary syndrome - Lymphomatoid papulosis - Nasal-type extranodal NK/T-cell lymphoma - Enteropathy-type T-cell lymphoma - Hepatosplenic T-cell lymphoma - Subcutaneous panniculitis-like T-cell lymphoma - Angioimmunoblastic T-cell lymphoma - Primary cutaneous anaplastic large cell lymphoma (ALCL) - ALCL with CD30, ALK, and EMA expression - ALCL morphology that fails to express ALK or EMA allowed provided T-cell lineage is confirmed by immunotyping or genetic testing - Bidimensionally measurable disease - Adequate samples (e.g., core biopsies, especially multiple core biopsies) from the original diagnostic specimen available - Needle aspiration or cytology is not considered adequate samples - No clinical evidence of Central nervous system (CNS) involvement by lymphoma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - Bilirubin ≤ 2 times upper limit of normal Renal - Creatinine clearance ≥ 30 mL/min Cardiovascular - No history of congestive heart failure - No history of myocardial infarction - No history of unstable angina - No history of asymptomatic arrhythmias - Ejection fraction normal by multigated acquisition (MUGA) scan (for patients with questionable cardiac history) - No other history of impaired cardiac status Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known HIV positivity - Mild clinical hearing loss allowed provided patient is willing to accept the potential for worsening of hearing loss - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - Must have had a chest x-ray or CT scan of the chest and a CT scan of the abdomen and pelvis within the past 28 days PRIOR CONCURRENT THERAPY: Biologic therapy - At least 3 weeks since prior biologic therapy - No concurrent routine use of bone marrow colony-stimulating factors Chemotherapy - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for this cancer - No concurrent radiotherapy Surgery - Not specified Other - No prior cytotoxic therapy for this cancer - Concurrent enrollment in SWOG-8819 or SWOG-8947 allowed

Additional Information

Official title Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Southwest Oncology Group.