Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer

Ovarian Neoplasms Clinical Trial

— ASSIST-5  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00350948
• Other study ID #: TLK286.3025
• Status: Terminated
• Phase: Phase 3
• First received: July 6, 2006
• Last updated: November 26, 2013
• Start date: May 2006
• Est. completion date: December 2008

Study information

• Verified date: November 2013
• Source: Telik
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Ministry of Social Affairs, Public Health and the EnvironmentUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a randomized, open label, multicenter, multinational Phase 3 study of TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) as compared to the active control therapy with liposomal doxorubicin (Doxil/Caelyx) as second line therapy in patients with platinum refractory or resistant recurrent ovarian cancer. Patients will be randomly assigned to receive either TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) or active control liposomal doxorubicin (Doxil/Caelyx).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 244
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Neoplasms

Intervention

Drug:
• Telcyta
Day 1 of 28 day Cycle.
• Liposomal Doxorubicin
Day 1 of 28 Day Cycle. 50 mg/m2

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Middelheim	Antwerpen
Belgium	A.Z. Groeninge Oncologish Centrum	Kortrijk
Belgium	Universitaire Ziekenhuizen Leuven Dienst Oncologie	Leuven
Brazil	Hospital Vera Cruz-Instituto de Oncologia	Belo Horizonte	MG
Brazil	Centr de Oncologia do Instituto de Radiologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Cerqueria Cesar	Sao Paulo
Brazil	Fundacao Hospital Amaral Carvalho	Rua Dona Siilveria	Sao Paulo
United Kingdom	Ninewells Hospital and Medical School	Dundee	Scotland
United Kingdom	Guy's & St. Thomas Cancer Centre	London	England
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	East Bay Medical Oncology/Hematology Medical Associates, Inc.	Antioch	California
United States	Arlington Cancer Center	Arlington	Texas
United States	Hope A Women's Cancer Center	Asheville	North Carolina
United States	Schwaartz Gynecologic Oncology, PLLC	Babylon	New York
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Desert Oasis Cancer Center	Casa Grande	Arizona
United States	Carolina Center of Gynecologic Oncology	Charleston	South Carolina
United States	Blumenthal Cancer Center	Charlotte	North Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	Palmetto Health Alliance-Richland	Columbia	South Carolina
United States	South Carolina Oncology Associates	Columbia	South Carolina
United States	Gynecologic Oncology & Pelvic Surgery Associates	Columbus	Ohio
United States	Bay Area Cancer Research Group, LLC	Concord	California
United States	East Bay Medical Oncology/Hematology Medical Associates	Concord	California
United States	The Mary Imogene Bassett Hospital	Cooperstown	New York
United States	Danville Hematology & Oncology, Inc.	Danville	Virginia
United States	Hematology & Oncology Associates of NEPA	Dunmore	Pennsylvania
United States	Dakota Cancer Institute/Dakota Clinic Ltd.	Fargo	North Dakota
United States	Flossmoor Cancer Care (JOHA DBA)	Flossmoor	Illinois
United States	California Oncology of the Central Valley	Fresno	California
United States	Gynecologic Oncology Associates, Inc	Hollywood	Florida
United States	Kaiser Permanente Moanalua Medical Center	Honolulu	Hawaii
United States	St. Vincent Gynecologic Oncology	Indianapolis	Indiana
United States	Shands Jacksonville Medical Center	Jacksonville	Florida
United States	University of Florida College of Medicine-Jacksonville	Jacksonville	Florida
United States	Joliet Oncology-Hematology Associates	Joliet	Illinois
United States	Joliet Oncology-Hematology Associates, LTD.	Joliet	Illinois
United States	Kankakee Cancer Center (JOHA DBA)	Kankakee	Illinois
United States	Monter Cancer Center	Lake Success	New York
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Piedmont Hematology Oncology Associates-Lexington Satellite	Lexington	North Carolina
United States	Hematology Oncology Services of Arkansas	Little Rock	Arkansas
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	North Shore University Hospital	Manhasset	New York
United States	Hematology and Oncology Specialists, LLC	Metairie	Louisiana
United States	Joliet Oncology-Hematology Associates	Morris	Illinois
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Women's Cancer Research Foundation	Newport Beach	California
United States	Hematology & Oncology Consultants P.C.	Omaha	Nebraska
United States	Florida Hospital	Orlando	Florida
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	Gynecologic Oncology Associates, Inc	Pembroke Pines	Florida
United States	Magee Women's Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Kaiser Permanente NW, Oncology/Hematology	Portland	Oregon
United States	Oregon Health & Science University	Portland	Oregon
United States	Southwest Cancer Care	Poway	California
United States	Desert Hematology Oncology Medical Group	Rancho Mirage	California
United States	Carilion GYN Oncology Associates	Roanoke	Virginia
United States	Southern California Permanente Medical Group	San Diego	California
United States	East Bay Medical Oncoogy/Hematology Medical Associates, Inc.	San Leandro	California
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Horizon's West Medical Group	Scottsbluff	Nebraska
United States	The Women's Center of Western Nebraska	Scottsbluff	Nebraska
United States	LSU Health Sciences Center	Shreveport	Louisiana
United States	Arch Medical Services	St. Louis	Missouri
United States	Garth Phibbs, M.D., FACOG	Toledo	Ohio
United States	The Toledo Hospital	Toledo	Ohio
United States	Arlington Cancer Center	Trophy Club	Texas
United States	Associates in Hematolog-Oncology, P.C.	Upland	Pennsylvania
United States	Diablo Valley Oncology & Hematology Medical Group, Inc.	Walnut Creek	California
United States	Piedmont Hematology Oncology Associates	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Telik

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin		Once 244 planned pts. received at least 2 cycles of study treatment(s)	Yes
Secondary	To evaluate and compare the safety profile of each treatment arm		Any patient who received 1 dose of study treatment(s) will be evaluable for safety.	Yes