A Phase I/II Study of BMS-247550 and Pegylated Liposomal Doxorubicin (Doxil®) in Patients With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer Who Have Been Previously Treated With a Platinum and a Taxane

Inclusion Criteria

Criteria:

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered.

- At least 1 week since prior chemotherapy if given on a daily or weekly schedule and
recovered.

- No prior doxorubicin HCl liposome.

- At least 3 weeks since prior radiotherapy and recovered.

- Recovered for more than 4 weeks from all adverse events related to prior agents.

- No other concurrent investigational agents.

- No concurrent combination antiretroviral therapy for HIV-positive patients.

- No other concurrent anticancer therapy.

- Has received a previous chemotherapy regimen for this cancer that included drugs such
as docetaxel or paclitaxel.

- Histologically or cytologically confirmed diagnosis of 1 of the following: advanced
ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer (phase I and
II) or metastatic breast cancer (phase I only).

- Measurable or evaluable disease, meeting 1 of the following criteria:

unidimensionally measurable lesion, known disease and CA 125 > 50 U/mL on 2 occasions >= 1
week apart or known disease and CA 27-29, CA 15-3, or CA 125 > 50 U/mL on 2 occasions >= 1
week apart (for breast cancer patients)

- ECOG 0-2 or Karnofsky 60-100%

- Life expectancy of more than 3 months

- Bilirubin normal

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No history of allergic reaction attributed to compounds of similar chemical or
biological composition to Cremophor® or study drugs

- No neuropathy >= grade 2

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance.

- No other uncontrolled illness.

- WBC >= 3,000/mm3

- Absolute neutrophil count >= 1,500/mm3

- Platelet count >= 100,000/mm3

- AST and ALT =< 2.5 times upper limit of normal (ULN)

- Creatinine =< 1.5 times ULN or Creatinine clearance ≥ 60 mL/min

- Platinum- and taxane-resistant disease, defined as a disease-free interval of < 6
months after completion of platinum- and taxane-based chemotherapy. Disease
progression during the regimen (phase II) or previously treated with >= 2 prior
regimens for metastatic breast cancer, including 1 taxane-based regimen in the
adjuvant or metastatic setting (phase I).

- Meets 1 of the following criteria: Previously treated with a standard course of
taxane- and platinum-based chemotherapy for ovarian epithelial, primary peritoneal
cavity, or fallopian tube cancer, that is platinum-refractory or -sensitive disease
(phase I );

- No active brain metastases, including any of the following: evidence of cerebral
edema by CT scan or MRI, evidence of disease progression on prior imaging studies,
requirement for steroids or clinical symptoms of brain metastasis.