A Randomized Phase II Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (PLD/Doxil/Caelyx) in Combination, Versus PLD Alone, in Subjects With Platinum-Resistant Ovarian Cancer
This is a Phase II clinical trial to evaluate the efficacy and safety of the combination of
EC145 and pegylated liposomal doxorubicin (PLD; available in the United States as Doxil® and
outside the United States as Caelyx®) compared to PLD alone.
EC145 is a drug that is specifically designed to enter cancer cells via the folate vitamin
receptor (FR). Experimental evidence shows that this target receptor is expressed on
virtually all ovarian cancers. Early clinical evidence in a small number of Phase I subjects
and in a subset of subjects in an on-going single-arm Phase II study suggests that EC145 may
have antitumor effect in women with advanced ovarian cancer and that it is generally
well-tolerated. This evidence suggests that EC145 may be useful as chemotherapy against
advanced ovarian cancer.
Patients at centers with EC20 imaging capability will also undergo imaging with the
FR-targeting investigational diagnostic agent EC20 during the screening period to assess
uptake of this agent into tumors. This non-invasive procedure will provide additional
information on the utility of EC20 imaging to identify subjects with the FR molecular
"target" before treatment with EC145 therapy.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival based on investigator assessment using RECIST and clinical findings
Assessed within 12 months following completion of accrual
No
Richard A Messmann, MD, MHS, MSc
Study Director
Endocyte
United States: Food and Drug Administration
EC-FV-04
NCT00722592
September 2008
December 2012
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Carilion Gynecologic Oncology Associates | Roanoke, Virginia 24014 |
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Arizona Clinical Research Center | Tucson, Arizona 85712 |
Medical College of Georgia | Augusta, Georgia 30912 |
Cancer Care Northwest | Spokane, Washington 99202 |
Broward Oncology Associates | Ft. Lauderdale, Florida 33308 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Metro Minnesota CCOP | St. Louis Park, Minnesota 55416 |
Texas Oncology | Dallas, Texas |
Gabrail Cancer Center | Canton, Ohio 44718 |
Pasco Pinellas Cancer Center | New Port Richey, Florida 34652 |
St. Vincent Gynecologic Oncology | Indianapolis, Indiana 46260 |
Minnesota Oncology Hematology, P.A. | Minneapolis, Minnesota 55407 |
South Austin Cancer Center | Austin, Texas 78745 |
Yale University School Of Medicine | New Haven, Connecticut 06520 |
Schwartz Gynecologic Oncology | Brightwaters, New York 11718 |
Chattanooga's Program in Women's Oncology | Chattanooga, Tennessee 37403 |
Northwest Cancer Specialists, P.C. | Vancouver, Washington |
Kapiolani Medical Center for Women & Children | Honolulu, Hawaii 96826 |
Northern Arizona Hematology and Oncology Associates | Flagstaff, Arizona 86001 |
Northern Arizona Hematology & Oncology Associates | Sedona, Arizona 86336 |
Puget Sound Cancer Centers | Edmonds, Washington 98026 |
Brody School of Medicine | Greenville, North Carolina 27858 |
Horizon Oncology Center | Lafayette, Indiana 47905 |
Karmanos Cancer Center | Detroit, Michigan 48201 |
Texas Oncology Cancer Care and Research Center | Waco, Texas 76712 |
New York Downtown Hospital | New York, New York 10038 |
Greater Cincinnati OB/GYN, Inc. | Cincinnati, Ohio 45267 |
Swedish Medical Center Cancer Institute | Seattle, Washington 98104 |
Women's Cancer Research Foundation | Newport Beach, California 92663 |
Center for Blood and Cancer Disorders | Bethesda, Maryland 20817 |
Texas Oncology-Central Austin Cancer Center | Austin, Texas 78731 |
Cancer Treatment Centers of America (CTCA-Midwestern) | Zion, Illinois 60099 |
Fountain Valley Regional Hospital and Medical Center | Fountain Valley, California 92708 |
Kaiser-Permanente Los Angeles Medical Center | Los Angeles, California 90027 |
North American Research Institute | West Covina, California 91790 |
Gainsville Hematology Oncology | Gainsville, Florida 32605 |
Univeristy of Louisville James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
Bluementhal Cancer Center | Charlotte, North Carolina 28232 |
Cancer Treatment Centers of America- Southwestern Regional Medical Center | Tulsa, Oklahoma 74133 |
Williamette Valley Cancer Center | Eugene, Oregon 97401 |
Northwest Cancer Specialists, PC- St. Vincent Cancer Center | Portland, Oregon 97225 |
Northwest Cancer Specialists, PC- Rose Qtr. Cancer Center | Portland, Oregon 97227 |
Northwest Cancer Specialists, PC - Hoyt Cancer Center | Portland, Oregon 97213 |
Northwest Cancer Specialists, PC- Tualatin Cancer Center | Tualatin, Oregon 97062 |
Texas Oncology- Central Austin | Austin, Texas 78705 |
Texas Oncology- Longview Cancer Center | Longview, Texas 75601 |
North Texas Regional Cacner Center | Plano, Texas 75075 |
Cancer Center of Northwest, P. A. -North | Spokane, Washington 99218 |
Cancer Care Northwest, PA- Valley | Spokane, Washington 99216 |
Northwest Cancer Specialists, PC- Vancouver Cancer Center | Vancouver, Washington 98684 |