Oxaliplatin and Topotecan in Advance Ovarian Cancer

PRIMARY OBJECTIVES:

I. Estimate the overall clinical response rate (complete and partial responses) in patients
with previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer
treated with oxaliplatin and topotecan.

II. Determine the toxic effects in patients treated with this regimen.

SECONDARY OBJECTIVES:

I. Estimate the time to progression and overall clinical response duration in patients
treated with this regimen.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
response to prior platinum therapy (resistant vs sensitive).

Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously
on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 30 days.

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

- 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

- 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

Exclusion criteria:

- 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