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NCT00109928 · REGISTRY CONDITION SEARCH

S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral T-Cell Non-Hodgkin's Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2014-10-01

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome

2-year Overall Survival Rate

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outcome

2-year Progression-free Survival Rate

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outcome

Response Rate

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outcome

Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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 Names
    1. Drug: cisplatin
    2. Drug: etoposide
    3. Drug: gemcitabine
    4. Drug: methylprednisolone
    label
    PEGS Treatment
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. PEGS Treatment
    name
    cisplatin
    type
    DRUG
  2. arm Group Labels
    1. PEGS Treatment
    name
    etoposide
    type
    DRUG
  3. arm Group Labels
    1. PEGS Treatment
    name
    gemcitabine
    type
    DRUG
  4. arm Group Labels
    1. PEGS Treatment
    name
    methylprednisolone
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
34
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    2-year Overall Survival Rate
    time Frame
    0-2 years
secondary Outcomes
  1. description
    Progression-free survival rate is the percentage of patients who do not show signs of progression at 2 years after registration to the study, including those whose disease has either completely or partially responded to treatment, or those whose disease is stable. Progression-free survival is defined as the time between study registration and documented progression, or death if no progression was observed.
    measure
    2-year Progression-free Survival Rate
    time Frame
    0-2 years
  2. description
    Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
    measure
    Response Rate
    time Frame
    up to 3 years or time of disease progression
  3. description
    Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
    measure
    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
Full study description
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.
Source references
references
  1. citation
    Mahadevan D, Unger JM, Spier CM, Persky DO, Young F, LeBlanc M, Fisher RI, Miller TP. Phase 2 trial of combined cisplatin, etoposide, gemcitabine, and methylprednisolone (PEGS) in peripheral T-cell non-Hodgkin lymphoma: Southwest Oncology Group Study S0350. Cancer. 2013 Jan 15;119(2):371-9. doi: 10.1002/cncr.27733. Epub 2012 Jul 25.
    pmid
    22833464
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        exact text
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      offset unit
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      query cond
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      query disease state id
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      source file
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      source string sha256
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    Preserved source evidence · Not medical advice