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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 Canc

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Trial Conditions
  • Ovarian Neoplasms
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Female

Eligibility

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

Gender: Female
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Drug
  • TLK286 in Combination with Carboplatin
  • Doxorubicin HCl Liposome Injection
Other Information

Sponsor: Telik
Phase: Phase 3
Trial ID: NCT00102973
Volunteers:  Not Accepting Healthy Volunteers

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