Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Yale University
With
OBJECTIVES: Primary * Determine the safety and tolerability of combination therapy comprising phenoxodiol and docetaxel in patients with recurrent or persistent advanced ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. Secondary * Determine the effect of phenoxodiol on the toxicity of docetaxel using a weekly treatment regimen. * Determine if combination therapy comprising phenoxodiol and docetaxel is more efficacious than docetaxel therapy alone. * Determine if combination therapy comprising phenoxodiol and docetaxel affects blood levels of either drug. * Determine phenotypic differences in the tumor cells of "responders" and "non-responders." OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15 and oral placebo three times daily on days 1-21. * Arm II: Patients receive oral phenoxodiol three times daily on days 1-21 and docetaxel as in arm I. Treatment in both arms repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed monthly for 6 months, every 3 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study. 3/31/2017 NOTE This study was terminated 10/2009 due to lack of enrollment. The study never progressed to Phase 2.
Age
18–120
Sex
FEMALE
Healthy volunteers
Not accepted
