Multi-Center, Phase Ib/IIa Safety and Preliminary Efficacy Study of Phenoxodiol (Intravenous) as a Chemo-Sensitizing Agent for Cisplatin and Paclitaxel in Epithelial Ovarian Cancer or Primary Peritoneal Cancer, Platinum- and/or Taxane-Refractory or Resistant

Date de début de l'étude : 1 août 2004

DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer * Recurrent disease * Received no more than 4 prior chemotherapy regimens for this malignancy * Considered refractory or resistant to prior taxane (paclitaxel or docetaxel) and/or platinum (cisplatin or carboplatin) therapy based on 1 of the following criteria: * Treatment-free interval \< 6 months after platinum or paclitaxel * Disease progression during platinum- or paclitaxel-based therapy * Measurable or evaluable disease * Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Evaluable disease is defined as doubling of CA 125 blood levels within the past 6 months AND CA 125 level ≥ 2 times upper limit of normal (ULN) within the past week * No active CNS metastases * Patients with known CNS metastases must have received prior radiotherapy or CNS-directed chemotherapy AND have ≥ 4 weeks of stable disease PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Karnofsky 60-100% Life expectancy * At least 3 months Hematopoietic * Neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * WBC \> 3,000/mm\^3 * Hematocrit ≥ 28% (transfusion or growth factors allowed) * Hemoglobin \> 8.0 g/dL (transfusion or growth factors allowed) Hepatic * Bilirubin ≤ 1.5 times ULN * SGOT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring antibiotics * No neuropathy (sensory or motor) \> grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy * No concurrent hormonal therapy for the malignancy Radiotherapy * See Disease Characteristics * No prior whole abdominal radiotherapy * Concurrent localized radiotherapy allowed for control of local complications not indicative of general disease progression Surgery * Not specified Other * Recovered from prior antineoplastic therapy * More than 4 weeks since prior standard therapy for malignant tumor * More than 6 months since prior investigational anticancer drugs * No other concurrent investigational drugs * No concurrent drugs significantly metabolized by the cytochrome P450 enzymes CYP2C8, CYP2C9, CYP2C19, and CYP3A4/B1C * No concurrent amifostine or other protective agents * No concurrent grapefruit juice