Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasms
Female
Ovarian Neoplasms
Trial Information
Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)
Inclusion Criteria:
- Are a woman 18 years of age or older
- Have histologically or cytologically confirmed epithelial cancer or primary
peritoneal cancer
- Have platinum refractory or resistant cancer
- Measurable disease according to radiographic RECIST criteria progression
Exclusion Criteria:
- Had treatment with first-line chemotherapy other than a platinum-containing regimen
- Have clinically significant cardiac disease
- Have any sign of intestinal obstruction interfering with nutrition
- Are pregnant or lactating
- Had prior treatment with liposomal doxorubicin
- Had prior treatment with Telcyta
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxirubicin as compared with the active control arm liposomal doxorubicin
Outcome Time Frame:
Once 244 planned pts. received at least 2 cycles of study treatment(s)
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
TLK286.3025
NCT ID:
NCT00350948
Start Date:
May 2006
Completion Date:
December 2008
Related Keywords:
- Ovarian Neoplasms
- Ovary
- Neoplasms
- Ovarian Neoplasms
Name | Location |
|---|---|
| Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| North Shore University Hospital | Manhasset, New York 11030 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Florida Hospital Cancer Institute | Orlando, Florida 32804 |
| Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Southern California Permanente Medical Group | Downey, California 90242 |
| Central Baptist Hospital | Lexington, Kentucky 40503 |
| Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
| Arlington Cancer Center | Arlington, Texas 76012 |
| Hope A Women's Cancer Center | Asheville, North Carolina 28801 |
| Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
| Southwest Cancer Care | Poway, California 92064 |
| Oregon Health & Science University | Portland, Oregon 97201 |
| South Carolina Oncology Associates | Columbia, South Carolina 29201 |
| Hematology Oncology Services of Arkansas | Little Rock, Arkansas 72205 |
| Blumenthal Cancer Center | Charlotte, North Carolina 28203 |
| California Oncology of the Central Valley | Fresno, California 93710 |
| Hematology and Oncology Specialists, LLC | New Orleans, Louisiana 70115 |
| St. Vincent Gynecologic Oncology | Indianapolis, Indiana 46260 |
| Carilion GYN Oncology Associates | Roanoke, Virginia 24014 |
| Bay Area Cancer Research Group, LLC | Concord, California 94520 |
| Danville Hematology & Oncology, Inc. | Danville, Virginia 24541 |
| LSU Health Sciences Center | Shreveport, Louisiana 71130-3932 |
| Florida Hospital | Orlando, Florida 32803 |
| Memorial Health University Medical Center | Savannah, Georgia 31404 |
| Joliet Oncology-Hematology Associates, Ltd. | Flossmoor, Illinois 60422 |
| Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
| Horizon's West Medical Group | Scottsbluff, Nebraska 69361 |
| The Mary Imogene Bassett Hospital | Cooperstown, New York 13326 |
| Hematology & Oncology Associates of NEPA | Dunmore, Pennsylvania 18512 |
| The Toledo Hospital | Toledo, Ohio 43606 |
| East Bay Medical Oncology/Hematology Medical Associates, Inc. | Antioch, California 94509 |
| Diablo Valley Oncology & Hematology Medical Group, Inc. | Walnut Creek, California 94598 |
| Piedmont Hematology Oncology Associates | Winston Salem, North Carolina 27103 |
| Desert Oasis Cancer Center | Casa Grande, Arizona 85222 |
| Shands Jacksonville Medical Center | Jacksonville, Florida 32209 |
| The Women's Center of Western Nebraska | Scottsbluff, Nebraska 69361 |
| Garth Phibbs, M.D., FACOG | Toledo, Ohio 43606 |
| Desert Hematology Oncology Medical Group | Rancho Mirage, California 92270 |
| Hematology & Oncology Consultants P.C. | Omaha, Nebraska 68122 |
| Arch Medical Services | St. Louis, Missouri 63141 |
| Monter Cancer Center | Lake Success, New York 11042 |
| Joliet Oncology-Hematology Associates | Joliet, Illinois 60435 |
| Kaiser Permanente Moanalua Medical Center | Honolulu, Hawaii 96819 |
| East Bay Medical Oncology/Hematology Medical Associates | Concord, California 94520 |
| Women's Cancer Research Foundation | Newport Beach, California 92663 |
| East Bay Medical Oncoogy/Hematology Medical Associates, Inc. | San Leandro, California 94578 |
| Gynecologic Oncology Associates, Inc | Hollywood, Florida 33020 |
| University of Florida College of Medicine-Jacksonville | Jacksonville, Florida 32209 |
| Flossmoor Cancer Care (JOHA DBA) | Flossmoor, Illinois 60422 |
| Kankakee Cancer Center (JOHA DBA) | Kankakee, Illinois 60901 |
| Schwaartz Gynecologic Oncology, PLLC | Babylon, New York 11702 |
| Piedmont Hematology Oncology Associates-Lexington Satellite | Lexington, North Carolina 27292 |
| Dakota Cancer Institute/Dakota Clinic Ltd. | Fargo, North Dakota 58103 |
| Gynecologic Oncology & Pelvic Surgery Associates | Columbus, Ohio 43222 |
| Kaiser Permanente NW, Oncology/Hematology | Portland, Oregon 97227 |
| Magee Women's Hospital of UPMC | Pittsburgh, Pennsylvania 15213 |
| Associates in Hematolog-Oncology, P.C. | Upland, Pennsylvania 19013 |
| Carolina Center of Gynecologic Oncology | Charleston, South Carolina 29407 |
| Palmetto Health Alliance-Richland | Columbia, South Carolina 29210 |
