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

NCT00109928 | Completed Phase 2 Results

• 3 other identifiers: CDR0000425643S0350U10CA032102
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 77

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.

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

Outcome Measures

Primary Outcomes (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.

  0-2 years

Secondary Outcomes (3)

• 2-year Progression-free Survival Rate

  0-2 years

• Response Rate

  up to 3 years or time of disease progression

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

  up to 18 weeks of protocol treatment

Study Arms (1)

PEGS Treatment

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

Drug: cisplatin; Drug: etoposide; Drug: gemcitabine; Drug: methylprednisolone

Interventions

cisplatin DRUG

PEGS Treatment

etoposide DRUG

PEGS Treatment

gemcitabine DRUG

PEGS Treatment

methylprednisolone DRUG

PEGS Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (77)

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5024, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Kaiser Permanente - Fremont

Fremont, California, 94538, United States

Location

Kaiser Permanente Medical Center - Hayward

Hayward, California, 94545, United States

Location

Kaiser Permanente Medical Center - Oakland

Oakland, California, 94611, United States

Location

South Sacramento Kaiser-Permanente Medical Center

Sacramento, California, 95823, United States

Location

Kaiser Permanente Medical Center - San Francisco Geary Campus

San Francisco, California, 94115, United States

Location

Kaiser Permanente Medical Center - Santa Teresa

San Jose, California, 95119, United States

Location

Kaiser Foundation Hospital - San Rafael

San Rafael, California, 94903, United States

Location

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Santa Clara, California, 95051, United States

Location

Kaiser Permanente Medical Center - Santa Rosa

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente Medical Center - South San Francisco

South San Francisco, California, 94080, United States

Location

Kaiser Permanente Medical Facility - Stockton

Stockton, California, 95210, United States

Location

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, 94589, United States

Location

Kaiser Permanente Medical Center - Walnut Creek

Walnut Creek, California, 94596, United States

Location

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

Hartford, Connecticut, 06105, United States

Location

M.D. Anderson Cancer Center at Orlando

Orlando, Florida, 32806, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Cotton-O'Neil Cancer Center

Topeka, Kansas, 66606, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Louisiana State University Health Sciences Center - Monroe

Monroe, Louisiana, 71210, United States

Location

Highland Clinic

Shreveport, Louisiana, 71105, United States

Location

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, 71130-3932, United States

Location

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, 48106-0995, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, 48123-2500, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

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

Grosse Pointe Woods, Michigan, 48236, United States

Location

Foote Memorial Hospital

Jackson, Michigan, 49201, United States

Location

Sparrow Regional Cancer Center

Lansing, Michigan, 48912-1811, United States

Location

St. Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

St. Joseph Mercy Oakland

Pontiac, Michigan, 48341-2985, United States

Location

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, 48060, United States

Location

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, 48601, United States

Location

St. John Macomb Hospital

Warren, Michigan, 48093, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare Cancer Care Services

Billings, Montana, 59101, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

St. James Healthcare Cancer Care

Butte, Montana, 59701, United States

Location

Great Falls Clinic - Main Facility

Great Falls, Montana, 59405, United States

Location

Sletten Cancer Institute at Benefis Healthcare

Great Falls, Montana, 59405, United States

Location

Unknown Facility

Great Falls, Montana, 59405, United States

Location

Northern Montana Hospital

Havre, Montana, 59501, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology at KRMC

Kalispell, Montana, 59901, United States

Location

Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

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

Missoula, Montana, 59807, United States

Location

Interlakes Oncology/Hematology PC

Rochester, New York, 14623, United States

Location

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

Rochester, New York, 14642, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Columbia Basin Hematology

Kennewick, Washington, 99336, United States

Location

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, 98273, United States

Location

Harrison Poulsbo Hematology and Onocology

Poulsbo, Washington, 98370, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Minor and James Medical, PLLC

Seattle, Washington, 98104, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

Polyclinic First Hill

Seattle, Washington, 98122, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Evergreen Hematology and Oncology, PS

Spokane, Washington, 99218, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801-2028, United States

Location

Rocky Mountain Oncology

Casper, Wyoming, 82609, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Anaplastic

Interventions

Cisplatin; Etoposide; Gemcitabine; Methylprednisolone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, T-Cell

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Study Statistician
• Organization: SWOG Statistical Center

206-667-4623

Study Officials

• Daruka Mahadevan, MD, PhD

  University of Arizona

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2005
• First Posted: May 4, 2005
• Study Start: September 1, 2005
• Primary Completion: June 1, 2012
• Study Completion: April 1, 2014
• Last Updated: October 1, 2014
• Results First Posted: August 29, 2014

Record last verified: 2014-09

Locations

US (77)