- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00303888
Docetaxel With or Without Phenoxodiol in Treating Patients With Recurrent Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
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
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520-8028
- Yale Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
Given orally
Given IV
|
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.
|
Given IV
Given orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Safety
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas J. Rutherford, MD, PhD, Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV ovarian epithelial cancer
- recurrent ovarian epithelial cancer
- recurrent fallopian tube cancer
- recurrent primary peritoneal cavity cancer
- stage IIIA ovarian epithelial cancer
- stage IIIB ovarian epithelial cancer
- stage IIIC ovarian epithelial cancer
- stage IIIA primary peritoneal cavity cancer
- stage IIIB primary peritoneal cavity cancer
- stage IIIC primary peritoneal cavity cancer
- stage IIIA fallopian tube cancer
- stage IIIB fallopian tube cancer
- stage IIIC fallopian tube cancer
- stage IV fallopian tube cancer
- stage IV primary peritoneal cavity cancer
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Abdominal Neoplasms
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- 0504027640
- YALE-HIC-27640
- YALE-012705
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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