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

Brief Title

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

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

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.

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 Phase

Phase 1

Study Type

Interventional

Primary Outcome

Survival (progression-free/recurrence-free interval and overall survival)

Condition

Fallopian Tube Cancer

Intervention

docetaxel

Study Arms / Comparison Groups

 Arm I

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

May 2006

Completion Date

October 2009

Primary Completion Date

August 2009

Eligibility Criteria

        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

Gender

Female

Ages

18 Years - 120 Years

Accepts Healthy Volunteers

No

Contacts

Thomas J. Rutherford, MD, PhD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00303888

Organization ID

0504027640

Secondary IDs

YALE-HIC-27640

Responsible Party

Sponsor

Study Sponsor

Yale University

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Thomas J. Rutherford, MD, PhD, Principal Investigator, Yale University

Verification Date

January 2018