A Randomized Placebo-Controlled Phase Ib/IIa Safety, Tolerability and Efficacy Study of Oral Phenoxodiol in Combination With Docetaxel Versus Docetaxel Alone in Patients With Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer
- 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.
- Determine the effect of phenoxodiol on the toxicity of docetaxel using a weekly
- 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
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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Survival (progression-free/recurrence-free interval and overall survival)
Thomas J. Rutherford, MD, PhD
|Yale Cancer Center||New Haven, Connecticut 06520-8028|