Multi-Center, Phase Ib/IIa Safety and Preliminary Efficacy Study of Phenoxodiol (Intravenous) as a Chemo-Sensitizing Agent for Cisplatin and Paclitaxel in Epithelial Ovarian Cancer or Primary Peritoneal Cancer, Platinum- and/or Taxane-Refractory or Resistant
- Compare the safety and tolerability of phenoxodiol combined with cisplatin or
paclitaxel in patients with recurrent late-stage ovarian epithelial, fallopian tube, or
primary peritoneal cancer that is refractory or resistant to platinum and/or taxane
- Compare, preliminarily, tumor response in patients treated with these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1
of 2 treatment arms according to medical history.
- Arm I: Patients receive phenoxodiol IV over 10 minutes on days 1 and 2 and cisplatin IV
over 1 hour on day 2.
- Arm II: Patients receive phenoxodiol as in arm I and paclitaxel IV over 1 hour on day
In both arms, treatment repeats every 6 weeks for up to 8 courses in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed at 12, 24, 36, and 48 weeks or at the end of study
Patients are followed at 6 and 12 months.
PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability
Average 6 mo
United States: Food and Drug Administration
|Yale Comprehensive Cancer Center at Yale University School of Medicine||New Haven, Connecticut 06520-8064|