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

Sponsor

Yale University (Other)

Overall Status

Terminated

CT.gov ID

NCT00303888

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer	Drug: docetaxel Drug: idronoxil Other: placebo	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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

Actual Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: docetaxel Given IV Other: placebo Given orally
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.	Drug: docetaxel Given IV Drug: idronoxil Given orally

Arm

Intervention/Treatment

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.

Drug: docetaxel

Given IV

Other: placebo

Given orally

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.

Drug: docetaxel

Given IV

Drug: idronoxil

Given orally

Outcome Measures

Primary Outcome Measures

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 []
Safety []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed diagnosis of 1 of the following:
Ovarian epithelial cancer
Fallopian tube cancer
Primary peritoneal cavity cancer
Recurrent advanced disease
Eligible for second-line to fifth-line chemotherapy
Received platinum and taxane combination chemotherapy as first-line treatment with disease recurrence > 6 months after conclusion of therapy
No demonstrated refractoriness or resistance to weekly docetaxel
Meets 1 of the following criteria:
Doubling of blood levels of CA125 in the past 6 months and CA125 levels ≥ 2 times upper limit of normal (ULN)
Measurable disease defined as ≥ 1 lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
No active CNS metastases
Prior CNS metastases allowed provided they were treated with radiation therapy and disease has been stable for 4 weeks

PATIENT CHARACTERISTICS:

Karnofsky performance score ≥ 60%
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
Life expectancy ≥ 3 months
Creatinine ≤ 1.5 mg/dL
Transaminases ≤ 3 times upper limit of normal (ULN)
Bilirubin normal
Platelet count > 100,000/mm^3
WBC > 3,000/mm^3
Neutrophil count > 1,500/mm^3
Hemoglobin ≥ 8.0 g/dL
Peripheral neuropathy ≤ grade 1
Relative proportions of AST, ALT, and alkaline phosphatase according 1 to the following criteria:
Alkaline phosphatase (AP) normal AND AST/ALT ≤ 5 times ULN
AP ≤ 2.5 times ULN AND AST/ALT ≤ 1.5 times ULN
AP ≤ 5 times ULN AND AST/ALT normal
No active infection
No concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, hypertension, ischemic heart disease, or congestive heart failure)
No history of chronic active hepatitis or cirrhosis
No history of severe hypersensitivity to docetaxel or other drugs formulated with polysorbate 80

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No investigational agents within 4 weeks prior to study entry
Recovered from prior antineoplastic therapy
No other concurrent investigational drugs
No other concurrent chemotherapy, radiotherapy, immunotherapy, or hormonal antitumor therapy
Concurrent localized radiation therapy allowed for control of local disease complications (e.g., bone metastases) that do not represent a general progression of the disease status
No concurrent grapefruit or grapefruit juice
No concurrent amifostine