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Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Sponsored by MEI Pharma, Inc.

About this trial

Last updated 10 years ago

Study ID

CDR0000389129

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18 to 120 Years
Female

Trial Timing

Ended 18 years ago

What is this trial about?

RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Phenoxodiol may help cisplatin and paclitaxel kill more tumor cells by making tumor cells more sensitive to the drugs. PURPOSE: This randomized phase I/II trial is studying the side effects of phenoxodiol when given together with either cisplatin or paclitaxel and to see how well they work in treating patients with recurrent late-stage ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that has not responded to treatment with drugs such as paclitaxel, docetaxel, cisplatin, or carboplatin.

What are the Participation Requirements?

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