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
31
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