TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer

Completed · Phase 3

Conditions studied: Ovarian Neoplasms

In brief

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.

Key facts

Study ID

NCT00102973

Run by

Telik

People needed

244

Starts

2004-12-01

Expected to finish

2008-07-01

Last updated by the study team

2012-05-31

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 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

You may not qualify if…

• 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

Where it is running

• Arkansas Oncology Associates — Little Rock, Arkansas, United States
• Little Rock Hematology Oncology — Little Rock, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Arkansas Oncology Associates — Little Rock, Arkansas, United States
• Southern California Permanente Medical Group — Anaheim, California, United States
• East Bay Oncology/Hematology Medical Associates, Inc. — Antioch, California, United States
• Southern California Permanente Medical Group — Baldwin Park, California, United States
• Southern California Permanente Medical Group — Bellflower, California, United States
• Marilyn Norton, M.D. — Chula Vista, California, United States
• Bay Area Cancer Research Group, LLC — Concord, California, United States
• East Bay Oncology/Hematology Medical Associates, Inc. — Concord, California, United States
• Southwest Cancer Care — Escondido, California, United States
• Southern California Permanente Medical Group — Fontana, California, United States
• California Oncology of the Central Valley — Fresno, California, United States
• Southern California Permanente Medical Group — Harbor City, California, United States
• Kaiser Permanente Medical Center — Hayward, California, United States
• Gynecologic Oncology Associates — La Jolla, California, United States
• Cancer Center Oncology Medical Group — La Mesa, California, United States
• LLU Faculty Medical Offices — Loma Linda, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Southern California Permanente Medical Group — Los Angeles, California, United States
• Southern California Permanente Medical Group — Los Angeles, California, United States
• Bowyer Oncology Center — Los Angeles, California, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Little Rock Hematology Oncology — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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