A Phase II Evaluation Of Pemetrexed (ALIMTA LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma
OBJECTIVES:
- Determine the antitumor activity of pemetrexed disodium in patients with recurrent or
persistent platinum-resistant ovarian epithelial or primary peritoneal cancer that
failed higher priority treatment protocols.
- Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
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 and continuing until 3 weeks after the last dose of pemetrexed
disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12)
intramuscularly every 9 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22
months.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Antitumor activity
No
David S. Miller, MD
Study Chair
Simmons Cancer Center
United States: Federal Government
CDR0000372919
NCT00087087
July 2004
Name | Location |
---|---|
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Dayton | Kettering, Ohio 45429 |
Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Women's Cancer Center - Las Vegas | Las Vegas, Nevada 89102 |
UMDNJ University Hospital | Newark, New Jersey 07103 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
Cancer Care Associates - Midtown Tulsa | Tulsa, Oklahoma 74104 |
M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia 23298-0037 |
Hope A Women's Cancer Center | Asheville, North Carolina 28801 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee | Knoxville, Tennessee 37901 |
Williamette Gynecologic Oncology PC | Portland, Oregon 97213 |