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

NCT00303888 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: 0504027640YALE-HIC-27640YALE-012705
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Arm I

EXPERIMENTAL

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; Other: placebo

Arm II

EXPERIMENTAL

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; Drug: idronoxil

Interventions

docetaxel DRUG

Given IV

Arm I; Arm II

idronoxil DRUG

Given orally

Arm II

placebo OTHER

Given orally

Arm I

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Docetaxel; phenoxodiol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Thomas J. Rutherford, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 17, 2006
• Study Start: May 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)