A Phase II Study of Oxaliplatin Combined With Continuous Infusion Topotecan as Chemotherapy for Patients With Previously Treated Ovarian Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or
fallopian tube cancer

- Meets 1 of the following criteria for response to prior platinum-based therapy:

- Platinum-resistant disease, defined as a disease-free interval of < 6 months
after prior platinum-based therapy OR progressive disease on a
platinum-containing regimen

- Platinum-sensitive disease, defined as a disease-free interval of > 6 months
after prior platinum-based therapy

- No symptomatic, untreated brain metastases

- Karnofsky performance status 70-100%

- WBC > 3,000/mm3

- Absolute neutrophil count > 1,500/mm3

- Platelet count > 100,000/mm3

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment

- No presence of any other active cancer

- No uncontrolled intercurrent illness, including the following:

- Infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- No history of severe allergy to platinum compounds

- (Mild reaction (skin only) allowed provided a negative skin test is obtained)

- No history of allergic reaction to appropriate antiemetics (e.g., 5HT3 antagonists)

- Recovered from prior chemotherapy

- At least 2 weeks since prior radiotherapy and recovered

- At least 4 weeks since prior investigational drugs

- No prior radiotherapy to the whole pelvic field

- No unresolved sequelae resulting from any surgical procedures

- No concurrent colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim
[GM-CSF]) during topotecan infusion

- No concurrent participation in another investigational trial

- No other concurrent investigational agents

- No other concurrent anticancer therapy

- Measurable or evaluable disease

- Measurable disease is characterized as lesions reproducibly measurable in 1 dimension

- Evaluable disease is defined as known disease with CA125 levels > 50 U/mL on 2
occasions >= 1 week apart

- Previously treated with a taxane and platinum-based regimen:

- Only 1 prior platinum-based regimen, including IV or intraperitoneal
consolidation

- One additional non-platinum and non-topotecan chemotherapy regimen allowed

- Any number of prior biologic therapies allowed

- Life expectancy >= 4 months

- Total bilirubin =< 1.5 times upper limit of normal (ULN)

- AST =< 2.5 times ULN (5 times ULN if liver metastases are present)

- Creatinine =< 1.5 times ULN AND creatinine clearance > 40 mg/dL

- HIV negative