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LymphomaPhase 2NCT00109928

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

A Phase 2 study testing cisplatin, etoposide and gemcitabine in people with Lymphoma, run by SWOG Cancer Research Network at 77 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
cisplatin, etoposide and gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
77 sitesUnited States
Study dates
Sep 2005to Apr 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

77 sites in 1 country.

77 sites in 1 country

United States77 sites

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Kaiser Permanente - Fremont

    Fremont, California, 94538

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Columbia Basin Hematology

    Kennewick, Washington, 99336

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Louisiana State University Health Sciences Center - Monroe

    Monroe, Louisiana, 71210

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Kaiser Permanente Medical Center - Oakland

    Oakland, California, 94611

  • M.D. Anderson Cancer Center at Orlando

    Orlando, Florida, 32806

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Harrison Poulsbo Hematology and Onocology

    Poulsbo, Washington, 98370

  • Interlakes Oncology/Hematology PC

    Rochester, New York, 14623

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • South Sacramento Kaiser-Permanente Medical Center

    Sacramento, California, 95823

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Kaiser Permanente Medical Center - San Francisco Geary Campus

    San Francisco, California, 94115

  • Kaiser Permanente Medical Center - Santa Teresa

    San Jose, California, 95119

  • Kaiser Foundation Hospital - San Rafael

    San Rafael, California, 94903

  • Kaiser Permanente Medical Center - Santa Clara Kiely Campus

    Santa Clara, California, 95051

  • Kaiser Permanente Medical Center - Santa Rosa

    Santa Rosa, California, 95403

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Highland Clinic

    Shreveport, Louisiana, 71105

  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences

    Shreveport, Louisiana, 71130-3932

  • Kaiser Permanente Medical Center - South San Francisco

    South San Francisco, California, 94080

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Evergreen Hematology and Oncology, PS

    Spokane, Washington, 99218

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Kaiser Permanente Medical Facility - Stockton

    Stockton, California, 95210

  • Cotton-O'Neil Cancer Center

    Topeka, Kansas, 66606

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724-5024

  • Kaiser Permanente Medical Center - Vallejo

    Vallejo, California, 94589

  • Kaiser Permanente Medical Center - Walnut Creek

    Walnut Creek, California, 94596

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Lymphoma
Keywords
stage III adult diffuse mixed cell lymphoma, stage IV adult diffuse mixed cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, anaplastic large cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Anaplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00109928
Study groupRoleWhat they receive
PEGS TreatmentExperimentalVP-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
Receives: Drug: cisplatin; Drug: etoposide; Drug: gemcitabine; Drug: methylprednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year Overall Survival Rate

    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.

    Measured: 0-2 years

Secondary outcomes (3)

  1. 2-year Progression-free Survival Rate

    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.

    Measured: 0-2 years

  2. Response Rate

    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.

    Measured: up to 3 years or time of disease progression

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

    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.

    Measured: up to 18 weeks of protocol treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionJun 2012
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00109928
Sponsor's protocol ID
CDR0000425643
Other IDs
S0350, U10CA032102
Status last verified
Sep 2014
First submitted
3 May 2005
Last updated
1 Oct 2014
Data monitoring committee
No

Publications

  • 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.

    PubMed 22833464

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, etoposide and gemcitabine in people with Lymphoma, run by SWOG Cancer Research Network at 77 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year Overall Survival Rate (time frame: 0-2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00109928, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.

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