Phase 2
N=34
S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral T-Cell Non-Hodgkin's Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00109928 ↗Enrolled (actual)
34
Serious AEs
15.2%
Results posted
Aug 2014
Primary outcome: Primary: 2-year Overall Survival Rate — 31 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cisplatin (Drug); etoposide (Drug); gemcitabine (Drug); methylprednisolone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SWOG Cancer Research Network
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2-year Overall Survival Rate |
31 | — |
| SECONDARY 2-year Progression-free Survival Rate |
12 | — |
| SECONDARY Response Rate |
6; 2; 5; 20 | — |
| SECONDARY Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug |
1; 1; 2; 1; 1; 1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00109928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.