Docetaxel With or Without Phenoxodiol in Treating Patients With Recurrent Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
Recruitment status was Recruiting
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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 Peritoneal Cavity Cancer |
Drug: docetaxel Drug: idronoxil Other: placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind 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 |
- Survival (progression-free/recurrence-free interval and overall survival) [ Designated as safety issue: No ]
- Tumor response as assessed by RECIST criteria and clinical examination [ Designated as safety issue: No ]
- Changes in tumor marker CA125 as assessed by Rustin criteria [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2006 |
| Estimated Primary Completion Date: | June 2008 (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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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| United States, Connecticut | |
| Yale Cancer Center | Recruiting |
| New Haven, Connecticut, United States, 06520-8028 | |
| Contact: Clinical Trials Office - Yale Cancer Center 203-785-5702 | |
| Principal Investigator: | Thomas J. Rutherford, MD, PhD | Yale University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00303888 History of Changes |
| Other Study ID Numbers: | CDR0000462103, YALE-HIC-27640, YALE-012705 |
| Study First Received: | March 15, 2006 |
| Last Updated: | October 28, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms |
Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms by Histologic Type Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013