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

• Status: Terminated
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel

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