Phase II Trial of Cisplatin Plus Etoposide Plus Gemcitabine Plus Solumedrol (PEGS) in Peripheral T-Cell Non-Hodgkin's Lymphoma
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
Measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact
0-2 years
No
Daruka Mahadevan, MD, PhD
Study Chair
University of Arizona
United States: Federal Government
CDR0000425643
NCT00109928
September 2005
March 2014
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Kaiser Permanente Medical Center - Vallejo | Vallejo, California 94589 |
Kaiser Permanente Medical Center - San Francisco Geary Campus | San Francisco, California 94115 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Kaiser Permanente Medical Center - Oakland | Sacramento, California 95825 |
Interlakes Oncology/Hematology PC | Rochester, New York 14623 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Peter's Hospital | Helena, Montana 59601 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Santa Clara, California 95051-5386 |
M.D. Anderson Cancer Center at Orlando | Orlando, Florida 32806 |
Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Kaiser Permanente - Fremont | Fremont, California 94538 |
Kaiser Permanente Medical Center - Hayward | Hayward, California 94545 |
South Sacramento Kaiser-Permanente Medical Center | Sacramento, California 95823 |
Kaiser Permanente Medical Center - Santa Teresa | San Jose, California 95119 |
Kaiser Foundation Hospital - San Rafael | San Rafael, California 94903 |
Kaiser Permanente Medical Center - Santa Rosa | Santa Rosa, California 95403 |
Kaiser Permanente Medical Center - South San Francisco | South San Francisco, California 94080 |
Kaiser Permanente Medical Facility - Stockton | Stockton, California 95210 |
Kaiser Permanente Medical Center - Walnut Creek | Walnut Creek, California 94596 |
Louisiana State University Health Sciences Center - Monroe | Monroe, Louisiana 71210 |
Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Polyclinic First Hill | Seattle, Washington 98122 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Cotton-O'Neil Cancer Center | Topeka, Kansas 66606 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Northern Montana Hospital | Havre, Montana 59501 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Columbia Basin Hematology | Kennewick, Washington 99336 |
Harrison Poulsbo Hematology and Onocology | Poulsbo, Washington 98370 |
Evergreen Hematology and Oncology, PS | Spokane, Washington 99218 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Great Falls, Montana 59405 | |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Highland Clinic | Shreveport, Louisiana 71105 |