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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00303888
First Posted: March 17, 2006
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Yale University
  Purpose

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 Intervention Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer Drug: docetaxel Drug: idronoxil Other: placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Yale University:

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

Enrollment: 31
Actual Study Start Date: May 2006
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303888


Locations
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
Sponsors and Collaborators
Yale University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Thomas J. Rutherford, MD, PhD Yale University
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00303888     History of Changes
Other Study ID Numbers: CDR0000462103
YALE-HIC-27640
YALE-012705
First Submitted: March 15, 2006
First Posted: March 17, 2006
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:
recurrent ovarian epithelial cancer
stage IV ovarian epithelial cancer
stage IIIA ovarian epithelial cancer
stage IIIB ovarian epithelial cancer
stage IIIC ovarian epithelial cancer
recurrent primary peritoneal cavity cancer
stage IIIA primary peritoneal cavity cancer
stage IIIB primary peritoneal cavity cancer
stage IIIC primary peritoneal cavity cancer
stage IV primary peritoneal cavity cancer
recurrent fallopian tube cancer
stage IIIA fallopian tube cancer
stage IIIB fallopian tube cancer
stage IIIC fallopian tube cancer
stage IV fallopian tube cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action