Docetaxel With or Without Phenoxodiol in Treating Patients With Recurrent Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenoxodiol may help docetaxel work better by making tumor cells more sensitive to the drug.
PURPOSE: This randomized phase I/II trial is studying the side effects of docetaxel when given together with either phenoxodiol or placebo and to see how well it works in treating patients with recurrent advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
|Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer||Drug: docetaxel Drug: idronoxil Other: placebo||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
|Official Title:||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|
- Survival (progression-free/recurrence-free interval and overall survival)
- Tumor response as assessed by RECIST criteria and clinical examination
- Changes in tumor marker CA125 as assessed by Rustin criteria
|Actual Study Start Date:||May 2006|
|Study Completion Date:||October 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Experimental: 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.
Given IVOther: placebo
Experimental: Arm II
Patients receive oral phenoxodiol three times daily on days 1-21 and docetaxel IV over 1 hour on days 1, 8, and 15.
Given IVDrug: idronoxil
- 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 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.
This study was terminated 10/2009 due to lack of enrollment. The study never progressed to Phase 2.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303888
|United States, Connecticut|
|Yale Cancer Center|
|New Haven, Connecticut, United States, 06520-8028|
|Principal Investigator:||Thomas J. Rutherford, MD, PhD||Yale University|