Phase III Randomized Study of TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasms
Female
Ovarian Neoplasms
Trial Information
Phase III Randomized Study of TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]
Inclusion Criteria:
- Are a woman 18 years of age or older
- Have histologically or cytologically confirmed epithelial cancer of the
ovary or fallopian tube, or primary peritoneal cancer
- Have platinum refractory or resistant cancer
- Measurable disease according to radiographic RECIST criteria with documented tumor
progression
Exclusion Criteria:
- Had treatment with first-line chemotherapy other than platinum-based regimens
(carboplatin or cisplatin)
- Have clinically significant cardiac disease
- Have any sign of intestinal obstruction interfering with nutrition at the time of
study entry
- Are pregnant or lactating
- Had prior treatment with liposomal doxorubicin for ovarian cancer
- Had prior treatment with TLK286
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:
Study Objectives
Outcome Description:
To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin
Outcome Time Frame:
Every 8 Weeks
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
TLK286.3024
NCT ID:
NCT00102973
Start Date:
December 2004
Completion Date:
July 2008
Related Keywords:
- Ovarian Neoplasms
- Ovary
- Neoplasms
- Ovarian Neoplasms
Name | Location |
|---|---|
| Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Hoag Memorial Hospital Presbyterian | Newport Beach, California 92658 |
| Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
| Marshfield Clinic | Marshfield, Wisconsin 54449 |
| Loma Linda University Medical Center | Loma Linda, California 92354 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
| Maine Medical Center | Portland, Maine 04102 |
| North Shore University Hospital | Manhasset, New York 11030 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Boston Medical Center | Boston, Massachusetts 02118 |
| Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Southern California Permanente Medical Group | Downey, California 90242 |
| Dakota Cancer Institute | Fargo, North Dakota 58103-4940 |
| Greenville Hospital System | Greenville, South Carolina 29605 |
| Barrett Cancer Center | Cincinnati, Ohio 45267-0502 |
| Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
| Arlington Cancer Center | Arlington, Texas 76012 |
| Duluth Clinic | Duluth, Minnesota 55805 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Hope A Women's Cancer Center | Asheville, North Carolina 28801 |
| Danville Hematology and Oncology, Inc. | Danville, Virginia 24541 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| Moses Taylor Hospital | Scranton, Pennsylvania 18510 |
| Miami Valley Hospital | Dayton, Ohio 45409 |
| Ellis Fischel Cancer Center | Columbia, Missouri 65203 |
| Marshfield Clinic - Lakeland Center | Minocqua, Wisconsin 54548 |
| Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
| Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
| St. John's Mercy Medical Center | Saint Louis, Missouri 63141 |
| Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
| Southeastern Gynecologic Oncology | Decatur, Georgia 30033 |
| Southwest Cancer Care | Poway, California 92064 |
| Spartanburg Regional Healthcare System | Spartanburg, South Carolina 29303 |
| Gynecologic Oncology Associates | Newport Beach, California 92663 |
| LaPorte Hospital | LaPorte, Indiana 46350-0250 |
| Saint Joseph's Regional Medical Center | South Bend, Indiana 46634-1935 |
| Saint Louis University | St. Louis, Missouri 63104 |
| Oregon Health & Science University | Portland, Oregon 97201 |
| Cancer Care Associates | Tulsa, Oklahoma 74136 |
| Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
| Caritas St. Elizabeth's Medical Center | Brighton, Massachusetts 02135-2997 |
| Deaconess Billings Clinic | Billings, Montana 59107-5100 |
| Parkridge Medical Center | Chattanooga, Tennessee 37404 |
| Kaiser Permanente Medical Center | Vallejo, California 94589 |
| Texas Cancer Associates | Dallas, Texas 75231 |
| Blumenthal Cancer Center | Charlotte, North Carolina 28203 |
| University Of Cincinnati Medical Center | Cincinnati,, Ohio 45267-0589 |
| Alegent Health Immanuel Medical Center | Omaha, Nebraska 68122 |
| California Oncology of the Central Valley | Fresno, California 93710 |
| Hematology and Oncology Specialists, LLC | New Orleans, Louisiana 70115 |
| Chattanooga GYN Oncology | Chattanooga, Tennessee 37403 |
| Carilion GYN Oncology Associates | Roanoke, Virginia 24014 |
| Bay Area Cancer Research Group, LLC | Concord, California 94520 |
| The Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| LSU Health Sciences Center | Shreveport, Louisiana 71130-3932 |
| Hematology-Oncology Associates of Rockland | Nyack, New York 10956 |
| Sharp Rees-Stealy | La Mesa, California 91942 |
| LLU Faculty Medical Offices | Loma Linda, California 92354 |
| David Geffen School of Medicine at UCLA | Los Angeles, California 90095 |
| N. County Oncology Medical | Oceanside, California 92056 |
| The Center for Hematology-Oncology | Boca Raton, Florida 33486 |
| Florida Hospital | Orlando, Florida 32803 |
| Memorial Health University Medical Center | Savannah, Georgia 31404 |
| OncRx (Pharmacy) | Metairie, Louisiana 70002 |
| Jersey Shore University Medical Center | Neptune, New Jersey 07754 |
| Robert Wood Johnson University Hospital | New Brunswick, New Jersey 08903 |
| The Mary Imogene Bassett Hospital | Cooperstown, New York 13326 |
| Presbyterian Gynecologic Oncology | Charlotte, North Carolina 28204 |
| UC Physician's Medical Arts Building | Cincinnati, Ohio 45219 |
| Hematology & Oncology Associates of NEPA | Dunmore, Pennsylvania 18512 |
| Viewmont Medical Services | Scranton, Pennsylvania 18508 |
| Community Medical Center | Scranton, Pennsylvania 18510 |
| Mercy Health Partners | Scranton, Pennsylvania 18510 |
| Associates in Hematology-Oncology, P.C. | Upland, Pennsylvania 19013 |
| Carolina Center of Gynecologic Oncology, PA | Charleston, South Carolina 29407 |
| Sioux Valley Clinic Oncology | Sioux Falls, South Dakota 57104 |
| Sioux Valley Hospital - North Center Radiology | Sioux Falls, South Dakota 57104 |
| Covington Multicare - Oncology Clinic | Covington, Washington 98042 |
| MultiCare Health System - Medical Oncology | Tacoma, Washington 98405 |
| Allenmore Hospital - Hematology Oncology Clinic | Tacoma, Washington 98405 |
| Schwartz Gynecologic Oncology | Brightwaters, New York 11718 |
| Kaiser Permanente Northwest Region | Portland, Oregon 97227 |
| The Family Cancer Center | Collierville, Tennessee 38017 |
| Western Washington Oncology, Inc., P.S. | Lacey, Washington 98503 |
| Lakeland Hospital | St. Joseph, Michigan 49085 |
| The Toledo Hospital | Toledo, Ohio 43606 |
| Clinical Trials and Research Associates, Inc. | Montebello, California 60460 |
| Diablo Valley Oncology & Hematology Medical Group, Inc. | Walnut Creek, California 94598 |
| Sparrow Health System | Lansing, Michigan 48912 |
| Horizons West Medical Group | Scottsbluff, Nebraska 69361 |
| Piedmont Hematology Oncology Associates | Winston Salem, North Carolina 27103 |
| Odyssey Research | Bismarck, North Dakota 58501 |
| Center for Oncology Research and Treatment, PA | Dallas, Texas 75230 |
| Odyssey Research | Scottsbluff, Nebraska 69361 |
| University of North Carolina at Chapel Hill | Chapel Hill, North Carolina 27599 |
| Citrus Hematology and Oncology Center | Inverness, Florida 34452 |
| Florida Wellcare Alliance, LC | Inverness, Florida 34452 |
| Center for Cancer and Blood Disorders, P. C. | Bethesda, Maryland 20817 |
| Oncology Care Medical Associates | Montebello, California 90640 |
| St. Vincent Hospital | Indianapolis, Indiana 46260 |
| Cancer and Blood Disease Center | Lecanto, Florida 34461 |
| Arkansas Oncology Associates | Little Rock, Arkansas 72205 |
| Little Rock Hematology Oncology | Little Rock, Arkansas 72205 |
| East Bay Oncology/Hematology Medical Associates, Inc. | Antioch, California 94509 |
| Marilyn Norton, M.D. | Chula Vista, California 91911 |
| Cancer Center Oncology Medical Group | La Mesa, California 91942 |
| OB/GYN Consult Suite | Los Angeles, California 90095 |
| Bowyer Oncology Center | Los Angeles, California 90095 |
| Beverly Oncology and Imaging | Montebello, California 90640 |
| Newport Imaging Center | Newport Beach, California 92660 |
| Sharp Memorial Hospital - Investigational Pharmacy | San Diego, California 92123 |
| Medical Oncology Associates | San Diego, California 92123 |
| Southern Permanente Medical Group | Woodland Hills, California 91367 |
| University of Connecticut Health Center/John Dempsey Hospital | Farmington, Connecticut 06030 |
| Citrus Diagnostic Center | Crystal River, Florida 34428 |
| GYN Oncology Associates, Inc. | Hollywood, Florida 33021 |
| Citrus Memorial Hospital Radiology Dept. | Inverness, Florida 34452 |
| Shands Jacksonville Medical Center | Jacksonville, Florida 32209 |
| Gynecology Oncology | Orlando, Florida 32804 |
| Florida Hospital Memorial System | Ormond Beach, Florida 32174 |
| Florida Hospital Memorial Division - Cancer Care Center | Ormond Beach, Florida 32174 |
| Kaiser Permanente Hawaii | Honolulu, Hawaii 96819 |
| Joliet Oncology-Hematology Associates, Inc. | Flossmoor, Illinois 60422 |
| University Medical Center, Inc. DBA: U of L Hospital | Louisville, Kentucky 40202 |
| Hematology and Oncology Specialist | New Orleans, Louisiana 70006 |
| Maine Medical Center - Brighton Campus | Portland, Maine 04102 |
| Maine Medical Center - Scarborough Campus | Scarborough, Maine 04074 |
| Dana Farber/Partners Cancer Care, Inc. | Boston, Massachusetts 02115 |
| Boston Medical Center - Center for Cancer and Blood Disorders | Boston, Massachusetts 02118 |
| Perceptive Informatics, Inc. | Waltham, Massachusetts 02451 |
| Providence Cancer Institute and Hospital | Southfield, Michigan 48075 |
| The Family Cancer Center | Olive Branch, Mississippi 38654 |
| St. John's Mercy-David C. Pratt Cancer Center | St. Louis, Missouri 63141 |
| Hematology & Oncology Consultants, PC | Omaha, Nebraska 68122 |
| The Women's Center of Western Nebraska | Scottsbluff, Nebraska 69361 |
| Regional West Medical Center | Scottsbluff, Nebraska 69361 |
| Mary Hitchcock Memorial Hospital/Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
| A. Richard Miskoff, DO, PA | Edison, New Jersey 08818 |
| JFK Medical Center | Edison, New Jersey 08818 |
| Jsumc Ob/Gyn | West Long Branch, New Jersey 07764 |
| Gynecologic Oncology & Minimally Invasive Surgery | Babylon, New York 11702 |
| The Union State Bank Cancer Center | Nyack, New York 10960 |
| Asheville Radiology | Asheville, North Carolina 28801 |
| Inpatient Pharmacy | Charlotte, North Carolina 28203 |
| Cancer Care Center - Medcenter One, Inc. | Bismarck, North Dakota 58501 |
| Cancer Treatment & Research Center - Mid Dakota Clinic, P. C. | Bismarck, North Dakota 58501 |
| Fairview Hospital Moll Pavilion | Cleveland, Ohio 44111 |
| Mid Ohio Onc/Hem (East) | Columbus, Ohio 43213 |
| Mid Ohio Onc/Hem (West) | Columbus, Ohio 43222 |
| GOPSA | Columbus, Ohio 43222 |
| Hillcrest Hospital/Cleveland Clinic Health System | Mayfield Heights, Ohio 44124 |
| ProMedica Health System | Toledo, Ohio 43606 |
| Garth Phibbs, M.D., FACOG | Toledo, Ohio 43606 |
| Mid Onio Onc/Hem (North) | Westerville, Ohio 43081 |
| Advance Imaging | Dunmore, Pennsylvania 18512 |
| Magee-Womens Hospital of UPMC | Pittsburgh, Pennsylvania 15213 |
| Roper Hospital-Department of Radiology | Charleston, South Carolina 29401 |
| South Carolina Oncology | Columbia, South Carolina 29210 |
| Sioux Valley Clinic OBGYN, Ltd. | Sioux Falls, South Dakota 57105 |
| Sioux Valley Clinic - Clinical Research Center | Sioux Falls, South Dakota 57104 |
| Baroness Erlander Hospital | Chattanooga, Tennessee 37403 |
| VCU Health System-Dalton Oncology Clinic, North Hospital | Richmond, Virginia 23298 |
| VCU Health System at Stony Point | Richmond, Virginia 23235 |
| Western Washington Oncology, Inc., P. S. | Centralia, Washington 98531 |
| Gig Harbor Medical Oncology | Gig Harbor, Washington 98335 |
| Marshfield Clinic - Chippewa Falls Center | Chippewa Falls, Wisconsin 54729 |
| Marshfield Clinic Cancer Care - Regional Cancer Center - Sacred Heart Hospital | Eau Claire, Wisconsin 54701 |
| St. Michael's Hospital | Stevens Point, Wisconsin 54481 |
| Marchfield Clinic - Wausau Center | Wausau, Wisconsin 54401 |
| Marshfield Clinic Weston Center | Weston, Wisconsin 54476 |
