TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer
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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.
Condition or disease
Drug: TLK286 in Combination with CarboplatinDrug: Doxorubicin HCl Liposome Injection
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 Start Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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