Phase 3 Randomized Study of TLK286 (Telcyta) Versus Doxil/Caelyx or Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-1 (Assessment of Survival In Solid Tumors-1)]
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) Versus Doxil/Caelyx or Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-1 (Assessment of Survival In Solid Tumors-1)]
Inclusion Criteria
Inclusion criteria include:
- Considered platinum refractory or resistant according to standard criteria
- Progressed during or following completion of one second-line treatment with
Doxil/Caelyx or Hycamtin
- Histologically or cytologically confirmed diagnosis of epithelial cancer of the
ovary, fallopian tube, or primary peritoneal cancer
- Measurable disease according to RECIST criteria with documented tumor progression
Exclusion criteria include:
- Treatment with second-line chemotherapy other than Doxil/Caelyx or Hycamtin
- History of whole pelvis radiation therapy within 12 months of enrollment
- Clinically significant cardiac disease
- Evidence of gross hematuria at the time of study entry
- Any signs of intestinal obstruction interfering with nutrition at the time of study
entry
- Pregnant or lactating women
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
TLK286.3017
NCT ID:
NCT00057720
Start Date:
June 2003
Completion Date:
December 2006
Related Keywords:
- Ovarian Neoplasms
- ovary
- Neoplasms
- Ovarian Neoplasms
Name | Location |
|---|---|
| University of Iowa | Iowa City, Iowa 52242 |
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
| St. Vincent Hospital and Health Care Center | Indianapolis, Indiana 46260 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
| Loma Linda University Medical Center | Loma Linda, California 92354 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
| University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
| Southern California Permanente Medical Group | Downey, California 90242 |
| Dakota Cancer Institute | Fargo, North Dakota 58103-4940 |
| MetroHealth Medical Center | Cleveland, Ohio 44109 |
| Barrett Cancer Center | Cincinnati, Ohio 45267-0502 |
| Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
| Arlington Cancer Center | Arlington, Texas 76012 |
| Oncology/Hematology Care, Inc. | Cincinnati, Ohio 45219 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Nevada Cancer Center | Las Vegas, Nevada 89109 |
| Danville Hematology and Oncology, Inc. | Danville, Virginia 24541 |
| North Shore Oncology Hematology Associates | Libertyville, Illinois 60048 |
| Midwest Cancer Research Group, Inc. | Skokie, Illinois 60077 |
| Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
| Moses Taylor Hospital | Scranton, Pennsylvania 18510 |
| Ellis Fischel Cancer Center | Columbia, Missouri 65203 |
| Saint Joseph's Hospital | Marshfield, Wisconsin 54449 |
| Marshfield Clinic - Lakeland Center | Minocqua, Wisconsin 54548 |
| Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
| Sharp Memorial Hospital | San Diego, California 92123 |
| Southwest Cancer Care | Poway, California 92064 |
| Hematology Oncology, P.C. | Stamford, Connecticut 06902 |
| St. Joseph Mercy Hospital | Pontiac, Michigan 48341-2985 |
| Metro Health Medical Center | Cleveland, Ohio 44109 |
| Gynecologic Oncology Associates | Newport Beach, California 92663 |
| Whittingham Cancer Center at Norwalk Hospital | Norwalk, Connecticut 06856 |
| Oregon Health & Science University | Portland, Oregon 97201 |
| South Carolina Oncology Associates, PA | Columbia, South Carolina 29210 |
| Indiana Cancer Pavilion | Indianapolis, Indiana 46202 |
| Deaconess Billings Clinic | Billings, Montana 59107-5100 |
| MacNeal Cancer Center | Berwyn, Illinois 60402 |
| Western Washington Oncology | Olympia, Washington 98502 |
| Salem Research Group, Inc. | Winston Salem, North Carolina 27103 |
| Straub Clinic and Hospital | Honolulu, Hawaii 96813 |
| Mid Dakota Clinic | Bismarck, North Dakota 58501 |
| Indiana University Medical Center | Indianapolis, Indiana 46202 |
| Texas Cancer Associates | Dallas, Texas 75231 |
| Blumenthal Cancer Center | Charlotte, North Carolina 28203 |
| Odyssey Research Services | Bismarck, North Dakota 58501 |
| California Oncology of the Central Valley | Fresno, California 93710 |
| Hematology and Oncology Specialists, LLC | New Orleans, Louisiana 70115 |
| Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
| St. Vincent Gynecologic Oncology | Indianapolis, Indiana 46260 |
| Gynecologic Oncology Research and Development | Greenville, South Carolina 29601 |
| Texas Oncology, PA | Dallas, Texas 75246-2006 |
| Decatur Memorial Hospital | Decatur, Illinois 62526 |
| Hematology Oncology Centers of the Northern Rockies | Billings, Montana 59101 |
| The Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| Wake Forest University School of Medicine | Winston-Salem, North Carolina 27157-1023 |
| LSU Health Sciences Center | Shreveport, Louisiana 71130-3932 |
| Hematology-Oncology Associates of Rockland | Nyack, New York 10956 |
| Little Rock Hematology Oncology Associates | Little Rock, Arkansas 72205 |
| Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
| Marilyn Norton, M. D. | Chula Vista, California 91911 |
| Rosalba Rodriguez, M. D. | Chula Vista, California 91911 |
| Bay Area Research Cancer Group | Concord, California 94520 |
| Kaiser Permanente Oncology Clinical Trials Program | Hayward, California 94545 |
| Sharp Rees-Stealy | La Mesa, California 91942 |
| Grossmont Hospital | La Mesa, California 91942 |
| LLU Faculty Medical Offices | Loma Linda, California 92354 |
| LLU Faculty Meidical Offices | Loma Linda, California 92354 |
| David Geffen School of Medicine at UCLA | Los Angeles, California 90095 |
| Women's Cancer Center - Community Hospital Los Gatos | Los Gatos, California 95032 |
| Gyncologic Oncology Associates | Newport Beach, California 92663 |
| N. County Oncology Medical | Oceanside, California 92056 |
| Sharp Healthcare Clinical Oncology Research | San Diego, California 92123 |
| Medical Oncology Associates-SD | San Diego, California 92123 |
| Kaiser Permanente Oncology Clinical Trails Program | Santa Teresa, California 95119 |
| Kaiser Permanente Oncology Clinial Trials Program | Walnut Creek, California 94596 |
| The Center for Hematology-Oncology | Boca Raton, Florida 33486 |
| Sheridan Clinical Research, Inc. | Hollywood, Florida 33021 |
| Memorial Regional Hospital | Hollywood, Florida 33021 |
| University of Florida Health Science Center/Jacksonville | Jacksonville, Florida 32209 |
| Florida Hospital | Orlando, Florida 32803 |
| Gynecologic Oncology | Orlando, Florida 32804 |
| Florida Hospital Memorial Division, Cancer Care Center | Ormond Beach, Florida 32174 |
| Florida Hospital Memorial Division | Ormond Beach, Florida 32174 |
| Gynecologic Oncology Associates | Pembroke Pines, Florida 33028 |
| Hematology/Oncology Associates of Treasure Coast | Port St. Lucie, Florida 34952 |
| Women's Cancer Research Foundation, Inc. | S. Miami, Florida 33143 |
| Suburban Hematology Oncology | Duluth, Georgia 30096 |
| Suburban Hematology-Oncology Associates | Lawrenceville, Georgia 30045 |
| Memorial Health University Medical Center | Savannah, Georgia 31404 |
| Univ. of Hawaii, Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
| Kaiser Permanente - Moanalua Medical Center | Honolulu, Hawaii 96819 |
| Hematology Oncology Associates of Illinois (HOAI) | Chicago, Illinois 60657 |
| Swedish Covenant Cancer Center | Chicago, Illinois 60625 |
| Cancer Care Specialists of Central IL | Decatur, Illinois 62526 |
| Cancer Care Specialists of Central IL-Crossroads Cancer Care Center | Effingham, Illinois 62401 |
| Joliet Oncology-Hematology Associates, Ltd. | Flossmoor, Illinois 60422 |
| North Shore Oncology Hematology Associates - Deerpath Medical Associates | Lake Forest, Illinois 60045 |
| Michiana Hematology Oncology | Elkhart, Indiana 46514 |
| St. Vincent Hospital and Helath Care Center | Indianapolis, Indiana 46260 |
| St. Joseph's Regional | South Bend, Indiana 46617 |
| Saint Joseph's Regional | South Bend, Indiana 46634 |
| Associates in Women's Health | Wichita, Kansas 67214 |
| Research Support Personnel, LLC | Wichita, Kansas 67208 |
| Oncology/Hematology Care, Inc. | Crestview, Kentucky 41017 |
| Univ. of Louisville, Div. of Gynecologic Oncology | Louisville, Kentucky 40202 |
| OncRx (Pharmacy) | Metairie, Louisiana 70002 |
| Sinai Cancer Institute | Baltimore, Maryland 21205 |
| Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
| St. Elizabeth's Med. Ctr. | Boston, Massachusetts 02135 |
| St. Mary's Duluth Clinic | Duluth, Minnesota 55805 |
| Gynecology & Oncology Consultants, PC | St. Louis, Missouri 63141 |
| St. Louis University, Dept. of Ob-Gyn and Women's Health | St. Louis, Missouri 63117 |
| Saint John's Mercy Hospital | St. Louis, Missouri 63141 |
| Hematology & Oncology Centers Northern Rockies | Billings, Montana 59101 |
| Horizon's West Medical Group | Scottsbluff, Nebraska 69361 |
| Jersey Shore University Medical Center | Neptune, New Jersey 07754 |
| Robert Wood Johnson University Hospital | New Brunswick, New Jersey 08903 |
| UNM Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
| Benjamin Schwartz, M.D. | Babylon, New York 11702 |
| The Mary Imogene Bassett Hospital | Cooperstown, New York 13326 |
| Med-Onc/Hem | Malone, New York 12953 |
| North Shore-Long Island Jewish Health System/Medical Center | New Hyde Park, New York 11040 |
| NYU School of Medicine | New York, New York 10016 |
| Comprehensive Cancer Center Medical Practice Offices | New York, New York 10016 |
| New York University Medical Center - Tisch Hospital | New York, New York 10016 |
| Bellevue Hospital Center | New York, New York 10016 |
| The Union State Bank Cancer Center at Nyack Hospital | Nyack, New York 10960 |
| Gynecologic-Oncology | Rochester, New York 14620 |
| South Bay OB/GYN | West Islip, New York 11795 |
| Good Samaritan Hospital Medical Center | West Islip, New York 11795 |
| Presbyterian Gynecologic Oncology | Charlotte, North Carolina 28204 |
| Presbyterian Hospital Center for Cancer Research | Charlotte, North Carolina 28204 |
| Piedmont Hematology Oncology Assoc., PA-Salem Research Group | Winston-Salem, North Carolina 27103 |
| University Hospital | Cincinnati, Ohio 45219 |
| UC Physician's Medical Arts Bldg. | Cincinnati, Ohio 45219 |
| UC Physician's Medical Arts Building | Cincinnati, Ohio 45219 |
| Mid-Ohio Oncology Hematology St. Anne's | Columbus, Ohio 43081 |
| Mid Ohio Oncology Hematology | Columbus, Ohio 43213 |
| Mount Carmel Health | Columbus, Ohio 43222 |
| Mid-Ohio Oncology Hematology | Columbus, Ohio 43213 |
| Gynecologic Oncology | Columbus, Ohio 43222 |
| Wright State Univ. School of Medicine | Dayton, Ohio 45409 |
| Hillcrest Hospital Cancer Center | Mayfield Heights, Ohio 44124 |
| OU Medical Center - Everett Tower | Oklahoma City, Oklahoma 73104 |
| Presbyterian | Oklahoma City, Oklahoma 73104 |
| OU Physicians' Bldg. | Oklahoma City, Oklahoma 73104 |
| Oregon Health Science University | Portland, Oregon 97239 |
| Kaiser Permanente Nw, Oncology Research | Portland, Oregon 97227 |
| Abington Mem. Hospita/Rosenfield Cancer Center | Abington, Pennsylvania 19001 |
| Hematology & Oncology Associates of NEPA | Dunmore, Pennsylvania 18512 |
| Advanced Imaging | 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 Calley Clinic OBGYN Ltd. | Sioux Falls, South Dakota 57105 |
| Sioux Valley Clinic Clinical Research Center | Sioux Falls, South Dakota 57104 |
| Sioux Valley Clinic Oncology | Sioux Falls, South Dakota 57104 |
| Sioux Valley Hospital - North Center Radiology | Sioux Falls, South Dakota 57104 |
| Chattanooga Oncology & Hematology Associates, P.C. | Chattanooga, Tennessee 37404 |
| Memorial Hospital | Chattanooga, Tennessee 37404 |
| The Consultant Group | Franklin, Tennessee 37067 |
| The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC | Gallatin, Tennessee 37066 |
| Saint Mary's Health System, Inc. | Knoxville, Tennessee 37917 |
| Fort Sanders Parkwest Medical Center | Knoxville, Tennessee 37923 |
| Hall and Martin, M.D.'s, P.C. | Knoxville, Tennessee 37920 |
| Amarillo Cancer Center | Amarillo, Texas 79106 |
| Dallas Oncology Consultants | Dallas, Texas 75201 |
| Southwest Fort Worth Cancer Center | Fort Worth, Texas 76132 |
| Univ. of TX, MD Anderson Cancer Center | Houston, Texas 77030 |
| Covington Multicare - Oncology Clinic | Covington, Washington 98042 |
| MultiCare Health System - Medical Oncology | Tacoma, Washington 98405 |
| Allenmore Hospital - Hematology Oncology Clinic | Tacoma, Washington 98405 |
| Chippewa Falls Cancer Center | Chippewa Falls, Wisconsin 54729 |
| Regional Cancer Center | Eau Claire, Wisconsin 54701 |
| Wisconsin Rapid Cancer Center | Marshfield, Wisconsin 54494 |
| Merrill Cancer Center | Merrill, Wisconsin 54452 |
| Medical Consultants, Ltd. | Milwaukee, Wisconsin 53215 |
| Marshfield Clinc - Lakeland Center | Minocqua, Wisconsin 54548 |
| Diagnostic Radiology Associates | Rice Lake, Wisconsin 54868 |
| Lakeview Medical Center | Rice Lake, Wisconsin 54868 |
| Saint Michael Hospital | Stevens Point, Wisconsin 54481 |
| Wausau Cancer Center | Wausau, Wisconsin 54401 |
| Hematology Oncology Centers of the Northern Rockies | Cody, Wyoming 82414 |
| Hematology Oncology of the Northern Rockies | Sheridan, Wyoming 82801 |
