Status:
TERMINATED
Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin 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 Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent o...
Detailed Description
This is a randomized, open label, multicenter, multinational Phase 3 study of TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) as compared to the active control therapy with l...
Eligibility Criteria
Inclusion
- Are a woman 18 years of age or older
- Have histologically or cytologically confirmed epithelial cancer or primary peritoneal cancer
- Have platinum refractory or resistant cancer
- Measurable disease according to radiographic RECIST criteria progression
Exclusion
- Had treatment with first-line chemotherapy other than a platinum-containing regimen
- Have clinically significant cardiac disease
- Have any sign of intestinal obstruction interfering with nutrition
- Are pregnant or lactating
- Had prior treatment with liposomal doxorubicin
- Had prior treatment with Telcyta
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT00350948
Start Date
May 1 2006
End Date
December 1 2008
Last Update
November 27 2013
Active Locations (71)
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1
Desert Oasis Cancer Center
Casa Grande, Arizona, United States, 85222
2
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, United States, 72205
3
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
4
East Bay Medical Oncology/Hematology Medical Associates, Inc.
Antioch, California, United States, 94509