Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Phenoxodiol may help cisplatin and paclitaxel kill more tumor cells by making tumor cells more sensitive to the drugs.
PURPOSE: This randomized phase I/II trial is studying the side effects of phenoxodiol when given together with either cisplatin or paclitaxel and to see how well they work in treating patients with recurrent late-stage ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that has not responded to treatment with drugs such as paclitaxel, docetaxel, cisplatin, or carboplatin.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Safety and tolerability [ Time Frame: Average 6 mo ] [ Designated as safety issue: Yes ]
- Efficacy [ Time Frame: Average 6 months ] [ Designated as safety issue: No ]
- Surrogate marker of tumor response in terms of plasma protein tNOX [ Time Frame: Average 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2004|
|Study Completion Date:||March 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Phenoxodiol IV 3 mg/kg combined with cisplatin 40 mg/m2 on Day 2 6 week cycles
IV 40 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.
Experimental: Arm B
Phenoxodiol IV 3 mg/kg combined with paclitaxel 80 mg/m2 on Day 2 6 week cycles
IV 80 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.
- 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 drugs.
- 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 2.
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 participation.
Patients are followed at 6 and 12 months.
PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study.
|United States, Connecticut|
|Yale Comprehensive Cancer Center at Yale University School of Medicine|
|New Haven, Connecticut, United States, 06520-8028|
|Royal Women's Hospital|
|Carlton, Victoria, Australia, 3053|
|Study Chair:||Warren Lancaster||Novogen|