Ovarian Neoplasms
Conditions
Keywords
Ovary
Brief summary
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.
Interventions
DRUGTLK286 in Combination with Carboplatin
Experimental Arm
Active Comparator
Sponsors
Telik
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Objectives | Every 8 Weeks | To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin |
Countries
United States
Outcome results
None listed