Docetaxel With or Without Phenoxodiol in Treating Patients With Recurrent Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring 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
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
Sites / Locations
- Yale Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I
Arm II
Patients receive docetaxel IV over 1 hour on days 1, 8, and 15 and oral placebo three times daily on days 1-21.
Patients receive oral phenoxodiol three times daily on days 1-21 and docetaxel IV over 1 hour on days 1, 8, and 15.