Phase II Trial of Pemetrexed for Advanced Chondrosarcomas
OBJECTIVES:
Primary
- Determine the response rate (confirmed and unconfirmed complete response and partial
response) in patients with recurrent and unresectable or metastatic chondrosarcoma
treated with pemetrexed disodium.
Secondary
- Determine the toxicity of this drug in these patients.
- Correlate, preliminarily, response rates with deletions of methylthioadenosine
phosphorylase (MTAP), as analyzed by fluorescence in-situ hybridization (FISH), in
patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to prior
chemotherapy (yes vs no).
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21
days* in the absence of disease progression or unacceptable toxicity. Beginning 7 days
before the first dose of pemetrexed disodium and continuing until 21 days after the
completion of pemetrexed disodium, patients receive cyanocobalamin (vitamin B_12)
intramuscularly once every 63 days and oral folic acid once daily.
NOTE: *The duration of course 1 is 28 days; the duration of all subsequent courses is 21
days.
Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients
achieving a confirmed partial response (PR) that is resectable, proceed to surgical
resection and then receive 2 additional courses of therapy after recovering from surgery.
Patients achieving a confirmed PR that is not resectable continue treatment in the absence
of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months until disease
progression and then every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 40-75 patients (20-40 in the previously treated stratum and
20-35 in the previously untreated stratum) will be accrued for this study within 20-37.5
months.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate as measured by RECIST criteria
x-rays or scans
every 9 weeks during treatment
No
Warren A. Chow, MD
Study Chair
Beckman Research Institute
United States: Federal Government
CDR0000415848
NCT00107419
September 2005
August 2009
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
St. Rita's Medical Center | Lima, Ohio 45801 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Great Falls Clinic | Great Falls, Montana 59405 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Vincent Healthcare | Billings, Montana 59101 |
Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
St. James Community Hospital | Butte, Montana 59701 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
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 |
Community Medical Center | Missoula, Montana 59801 |
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 |
North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Community Oncology Group at Cleveland Clinic Cancer Center | Independence, Ohio 44131 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
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 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Methodist Cancer Center at Methodist Hospital - Omaha | Omaha, Nebraska 68114 |
Oregon Health & Science University Cancer Institute | Portland, Oregon 97239-3098 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
AnMed Health Cancer Center | Anderson, South Carolina 29621 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Great Falls, Montana 59405 | |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |