Clinical trial NCT00102973: TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer
Official title: 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]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Neoplasms
Keywords: Ovary
Lead sponsor: Telik
Sponsor class: INDUSTRY
First posted: 2005-02-07
Enrollment: 244
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine if TLK286 given in combination with carboplatin is more effective than liposomal doxorubicin in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer, that is refractory or resistant to platinum chemotherapy.


Eligibility criteria: 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

Primary outcomes:
measure: Study Objectives
timeFrame: Every 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Little Rock Hematology Oncology
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Oncology Associates
state: Arkansas
city: Little Rock
country: United States
facility: Little Rock Hematology Oncology
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Oncology Associates
state: Arkansas
city: Anaheim
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Antioch
country: United States
facility: East Bay Oncology/Hematology Medical Associates, Inc.
state: California
city: Baldwin Park
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Bellflower
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Chula Vista
country: United States
facility: Marilyn Norton, M.D.
state: California
city: Concord
country: United States
facility: Bay Area Cancer Research Group, LLC
state: California
city: Concord
country: United States
facility: East Bay Oncology/Hematology Medical Associates, Inc.
state: California
city: Escondido
country: United States
facility: Southwest Cancer Care
state: California
city: Fontana
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Fresno
country: United States
facility: California Oncology of the Central Valley
state: California
city: Harbor City
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Hayward
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: La Jolla
country: United States
facility: Gynecologic Oncology Associates
state: California
city: La Mesa
country: United States
facility: Cancer Center Oncology Medical Group
state: California
city: Loma Linda
country: United States
facility: LLU Faculty Medical Offices
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Los Angeles
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Los Angeles
country: United States
facility: Bowyer Oncology Center
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: Los Angeles
country: United States
facility: OB/GYN Consult Suite
state: California
city: Montebello
country: United States
facility: Beverly Oncology and Imaging
state: California
city: Montebello
country: United States
facility: Clinical Trials and Research Associates, Inc.
state: California
city: Montebello
country: United States
facility: Oncology Care Medical Associates
state: California
city: Murrieta
country: United States
facility: Southwest Cancer Care
state: California
city: Newport Beach
country: United States
facility: Newport Imaging Center
state: California
city: Newport Beach
country: United States
facility: Gynecologic Oncology Associates
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Oceanside
country: United States
facility: N. County Oncology Medical
state: California
city: Panorama City
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Poway
country: United States
facility: Southwest Cancer Care
state: California
city: Riverside
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: San Diego
country: United States
facility: Medical Oncology Associates
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital - Investigational Pharmacy
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: San Gabriel
country: United States
facility: Oncology Care Medical Associates
state: California
city: San Jose
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Walnut Creek
country: United States
facility: Diablo Valley Oncology & Hematology Medical Group, Inc.
state: California
city: Whittier
country: United States
facility: Oncology Care Medical Associates
state: California
city: Woodland Hills
country: United States
facility: Southern Permanente Medical Group
state: California
city: Farmington
country: United States
facility: University of Connecticut Health Center/John Dempsey Hospital
state: Connecticut
city: Boca Raton
country: United States
facility: The Center for Hematology-Oncology
state: Florida
city: Crystal River
country: United States
facility: Citrus Diagnostic Center
state: Florida
city: Crystal River
country: United States
facility: Citrus Hematology and Oncology Center
state: Florida
city: Crystal River
country: United States
facility: Citrus Hematology and Oncology Center
state: Florida
city: Delray Beach
country: United States
facility: The Center for Hematology-Oncology
state: Florida
city: Hollywood
country: United States
facility: GYN Oncology Associates, Inc.
state: Florida
city: Inverness
country: United States
facility: Citrus Hematology and Oncology Center
state: Florida
city: Inverness
country: United States
facility: Citrus Memorial Hospital Radiology Dept.
state: Florida
city: Inverness
country: United States
facility: Florida Wellcare Alliance, LC
state: Florida
city: Jacksonville
country: United States
facility: Shands Jacksonville Medical Center
state: Florida
city: Jupiter
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Lecanto
country: United States
facility: Cancer and Blood Disease Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Orlando
country: United States
facility: Gynecology Oncology
state: Florida
city: Ormond Beach
country: United States
facility: Florida Hospital Memorial Division - Cancer Care Center
state: Florida
city: Ormond Beach
country: United States
facility: Florida Hospital Memorial System
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Pembroke Pines
country: United States
facility: GYN Oncology Associates, Inc.
state: Florida
city: Wellington
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Atlanta
country: United States
facility: Southeastern Gynecologic Oncology
state: Georgia
city: Lawrenceville
country: United States
facility: Southeastern Gynecologic Oncology
state: Georgia
city: Marietta
country: United States
facility: Southeastern Gynecologic Oncology
state: Georgia
city: Riverdale
country: United States
facility: Southeastern Gynecologic Oncology
state: Georgia
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Tucker
country: United States
facility: Southeastern Gynecologic Oncology
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente Hawaii
state: Hawaii
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Flossmoor
country: United States
facility: Joliet Oncology-Hematology Associates, Inc.
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Inc.
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Inc.
state: Illinois
city: Kankakee
country: United States
facility: Joliet Oncology-Hematology Associates, Inc.
state: Illinois
city: Morris
country: United States
facility: Joliet Oncology-Hematology Associates, Inc.
state: Illinois
city: Elkhart
country: United States
facility: Elkhart General Hospital
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: LaPorte
country: United States
facility: LaPorte Hospital
state: Indiana
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: South Bend
country: United States
facility: Saint Joseph's Regional Medical Center
state: Indiana
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: University Medical Center, Inc. DBA: U of L Hospital
state: Kentucky
city: Covington
country: United States
facility: Hematology and Oncology Specialists, LLC
state: Louisiana
city: Metairie
country: United States
facility: OncRx (Pharmacy)
state: Louisiana
city: New Orleans
country: United States
facility: Hematology and Oncology Specialist
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center - Brighton Campus
state: Maine
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Scarborough
country: United States
facility: Maine Medical Center - Scarborough Campus
state: Maine
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders, P. C.
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber/Partners Cancer Care, Inc.
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center - Center for Cancer and Blood Disorders
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Waltham
country: United States
facility: Perceptive Informatics, Inc.
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Health System
state: Michigan
city: Niles
country: United States
facility: Lakeland Hospital
state: Michigan
city: Southfield
country: United States
facility: Providence Cancer Institute and Hospital
state: Michigan
city: St. Joseph
country: United States
facility: Lakeland Hospital
state: Michigan
city: Duluth
country: United States
facility: Duluth Clinic
state: Minnesota
city: Olive Branch
country: United States
facility: The Family Cancer Center
state: Mississippi
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center
state: Missouri
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
city: St. Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: St. Louis
country: United States
facility: St. John's Mercy-David C. Pratt Cancer Center
state: Missouri
city: Billings
country: United States
facility: Deaconess Billings Clinic
state: Montana
city: Omaha
country: United States
facility: Alegent Health Immanuel Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Hematology & Oncology Consultants, PC
state: Nebraska
city: Scottsbluff
country: United States
facility: Horizons West Medical Group
state: Nebraska
city: Scottsbluff
country: United States
facility: Odyssey Research
state: Nebraska
city: Scottsbluff
country: United States
facility: Regional West Medical Center
state: Nebraska
city: Scottsbluff
country: United States
facility: The Women's Center of Western Nebraska
state: Nebraska
city: Lebanon
country: United States
facility: Mary Hitchcock Memorial Hospital/Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Edison
country: United States
facility: A. Richard Miskoff, DO, PA
state: New Jersey
city: Edison
country: United States
facility: JFK Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: The Cancer Institute of New Jersey
state: New Jersey
city: West Long Branch
country: United States
facility: Jsumc Ob/Gyn
state: New Jersey
city: Babylon
country: United States
facility: Gynecologic Oncology & Minimally Invasive Surgery
state: New York
city: Cooperstown
country: United States
facility: The Mary Imogene Bassett Hospital
state: New York
city: East Islip
country: United States
facility: Schwartz Gynecologic Oncology
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New City
country: United States
facility: Hematology-Oncology Associates of Rockland
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Nyack
country: United States
facility: The Union State Bank Cancer Center
state: New York
city: Asheville
country: United States
facility: Asheville Radiology
state: North Carolina
city: Asheville
country: United States
facility: Hope A Women's Cancer Center
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Inpatient Pharmacy
state: North Carolina
city: Charlotte
country: United States
facility: Blumenthal Cancer Center
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Gynecologic Oncology
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Winston Salem
country: United States
facility: Piedmont Hematology Oncology Associates
state: North Carolina
city: Bismarck
country: United States
facility: Cancer Care Center - Medcenter One, Inc.
state: North Dakota
city: Bismarck
country: United States
facility: Cancer Treatment & Research Center - Mid Dakota Clinic, P. C.
state: North Dakota
city: Bismarck
country: United States
facility: Odyssey Research
state: North Dakota
city: Fargo
country: United States
facility: Dakota Cancer Institute
state: North Dakota
city: Fargo
country: United States
facility: Odyssey Research
state: North Dakota
city: Cincinnati
country: United States
facility: Barrett Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: UC Physician's Medical Arts Building
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Fairview Hospital Moll Pavilion
state: Ohio
city: Columbus
country: United States
facility: Mid Ohio Onc/Hem (East)
state: Ohio
city: Columbus
country: United States
facility: GOPSA
state: Ohio
city: Columbus
country: United States
facility: Mid Ohio Onc/Hem (West)
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Hospital/Cleveland Clinic Health System
state: Ohio
city: Toledo
country: United States
facility: Garth Phibbs, M.D., FACOG
state: Ohio
city: Toledo
country: United States
facility: ProMedica Health System
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Westerville
country: United States
facility: Mid Onio Onc/Hem (North)
state: Ohio
city: Tulsa
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Portland
country: United States
facility: Kaiser Permanente Northwest Region
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Dunmore
country: United States
facility: Advance Imaging
state: Pennsylvania
city: Dunmore
country: United States
facility: Hematology & Oncology Associates of NEPA
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Scranton
country: United States
facility: Hematology & Oncology Associates of NEPA
state: Pennsylvania
city: Scranton
country: United States
facility: Viewmont Medical Services
state: Pennsylvania
city: Scranton
country: United States
facility: Community Medical Center
state: Pennsylvania
city: Scranton
country: United States
facility: Mercy Health Partners
state: Pennsylvania
city: Scranton
country: United States
facility: Moses Taylor Hospital
state: Pennsylvania
city: Upland
country: United States
facility: Associates in Hematology-Oncology, P.C.
state: Pennsylvania
city: Charleston
country: United States
facility: Roper Hospital-Department of Radiology
state: South Carolina
city: Charleston
country: United States
facility: Carolina Center of Gynecologic Oncology, PA
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Oncology
state: South Carolina
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Healthcare System
state: South Carolina
city: Sioux Falls
country: United States
facility: Sioux Valley Clinic - Clinical Research Center
state: South Dakota
city: Sioux Falls
country: United States
facility: Sioux Valley Clinic Oncology
state: South Dakota
city: Sioux Falls
country: United States
facility: Sioux Valley Hospital - North Center Radiology
state: South Dakota
city: Sioux Falls
country: United States
facility: Sioux Valley Clinic OBGYN, Ltd.
state: South Dakota
city: Bartlett
country: United States
facility: The Family Cancer Center
state: Tennessee
city: Chattanooga
country: United States
facility: Baroness Erlander Hospital
state: Tennessee
city: Chattanooga
country: United States
facility: Chattanooga GYN Oncology
state: Tennessee
city: Chattanooga
country: United States
facility: Parkridge Medical Center
state: Tennessee
city: Collierville
country: United States
facility: The Family Cancer Center
state: Tennessee
city: Memphis
country: United States
facility: The Family Cancer Center
state: Tennessee
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Dallas
country: United States
facility: Center for Oncology Research and Treatment, PA
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Associates
state: Texas
city: Plano
country: United States
facility: Texas Cancer Associates
state: Texas
city: Richardson
country: United States
facility: Center for Oncology Research and Treatment, PA
state: Texas
city: Danville
country: United States
facility: Danville Hematology and Oncology, Inc.
state: Virginia
city: Richmond
country: United States
facility: VCU Health System at Stony Point
state: Virginia
city: Richmond
country: United States
facility: VCU Health System-Dalton Oncology Clinic, North Hospital
state: Virginia
city: Roanoke
country: United States
facility: Carilion GYN Oncology Associates
state: Virginia
city: Aberdeen
country: United States
facility: Western Washington Oncology, Inc., P.S.
state: Washington
city: Centralia
country: United States
facility: Western Washington Oncology, Inc., P. S.
state: Washington
city: Covington
country: United States
facility: Covington MultiCare - Oncology Clinic
state: Washington
city: Gig Harbor
country: United States
facility: Gig Harbor Medical Oncology
state: Washington
city: Lacey
country: United States
facility: Western Washington Oncology, Inc., P.S.
state: Washington
city: Shelton
country: United States
facility: Western Washington Oncology, Inc., P.S.
state: Washington
city: Tacoma
country: United States
facility: Allenmore Hospital - Hematology Oncology Clinic
state: Washington
city: Tacoma
country: United States
facility: MultiCare Health System - Medical Oncology
state: Washington
city: Chippewa Falls
country: United States
facility: Marshfield Clinic - Chippewa Falls Center
state: Wisconsin
city: Eau Claire
country: United States
facility: Marshfield Clinic Cancer Care - Regional Cancer Center - Sacred Heart Hospital
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Minocqua
country: United States
facility: Marshfield Clinic - Lakeland Center
state: Wisconsin
city: Rice Lake
country: United States
facility: Marshfield Clinic - Indianhead Center
state: Wisconsin
city: Stevens Point
country: United States
facility: St. Michael's Hospital
state: Wisconsin
city: Wausau
country: United States
facility: Marchfield Clinic - Wausau Center
state: Wisconsin
city: Weston
country: United States
facility: Marshfield Clinic Weston Center
state: Wisconsin
city: Wisconsin Rapids
country: United States
facility: Marshfield Clinic - Wisconsin Rapids Center
state: Wisconsin
Study officials:
References: