Symptoms and General Pathology

All Conditions

Neoplasms

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Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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Gastrointestinal Diseases

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Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

Patients receive docetaxel IV over 1 hour on days 1, 8, and 15 and oral placebo three times daily on days 1-21.

Patients receive oral phenoxodiol three times daily on days 1-21 and docetaxel IV over 1 hour on days 1, 8, and 15.

docetaxel

idronoxil

placebo

Thomas J. Rutherford, MD, PhD

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.

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.

Docetaxel With or Without Phenoxodiol in Treating Patients With Recurrent Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

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

National Cancer Institute (NCI)

Yale University

Spots Global Cancer Trial Database for idronoxil

Every month we try and update this database with for idronoxil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for idronoxil

Every month we try and update this database with for idronoxil cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for idronoxil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.