Status:
COMPLETED
TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer
Lead Sponsor:
Telik
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT00102973
Start Date
December 1 2004
End Date
July 1 2008
Last Update
May 31 2012
Active Locations (222)
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1
Little Rock Hematology Oncology
Little Rock, Arkansas, United States, 72117
2
Arkansas Oncology Associates
Little Rock, Arkansas, United States, 72205
3
Little Rock Hematology Oncology
Little Rock, Arkansas, United States, 72205
4
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205