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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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
docetaxel
idronoxil
placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Yale Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

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.

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
March 15, 2006
Last Updated
January 12, 2018
Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00303888
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Study Start Date
May 2006 (Actual)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive docetaxel IV over 1 hour on days 1, 8, and 15 and oral placebo three times daily on days 1-21.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive oral phenoxodiol three times daily on days 1-21 and docetaxel IV over 1 hour on days 1, 8, and 15.
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
idronoxil
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Survival (progression-free/recurrence-free interval and overall survival)
Title
Tumor response as assessed by RECIST criteria and clinical examination
Title
Changes in tumor marker CA125 as assessed by Rustin criteria
Title
Safety

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J. Rutherford, MD, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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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

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