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

Inclusion Criteria

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