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

Stopped early · Phase 3

Conditions studied: Ovarian Neoplasms

In brief

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.

Key facts

Study ID

NCT00350948

Run by

Telik

People needed

244

Starts

2006-05-01

Expected to finish

2008-12-01

Last updated by the study team

2013-11-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hematology Oncology Services of Arkansas — Little Rock, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• East Bay Medical Oncology/Hematology Medical Associates, Inc. — Antioch, California, United States
• Bay Area Cancer Research Group, LLC — Concord, California, United States
• East Bay Medical Oncology/Hematology Medical Associates — Concord, California, United States
• California Oncology of the Central Valley — Fresno, California, United States
• Women's Cancer Research Foundation — Newport Beach, California, United States
• Southwest Cancer Care — Poway, California, United States
• Desert Hematology Oncology Medical Group — Rancho Mirage, California, 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
• Diablo Valley Oncology & Hematology Medical Group, Inc. — Walnut Creek, California, United States
• Gynecologic Oncology Associates, Inc — Hollywood, Florida, United States
• Shands Jacksonville Medical Center — Jacksonville, Florida, United States
• University of Florida College of Medicine-Jacksonville — Jacksonville, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Gynecologic Oncology Associates, Inc — Pembroke Pines, Florida, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• Kaiser Permanente Moanalua Medical Center — Honolulu, Hawaii, United States
• Flossmoor Cancer Care (JOHA DBA) — Flossmoor, Illinois, 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
• Desert Oasis Cancer Center — Casa Grande, Arizona, United States

Full record on ClinicalTrials.gov

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