Oxaliplatin and Topotecan in Advance Ovarian Cancer
Recurrent Ovarian Epithelial Cancer
About this trial
This is an interventional treatment trial for Recurrent Ovarian Epithelial Cancer
Eligibility Criteria
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
Sites / Locations
- Montefiore Medical Center
- NYU Cancer Institute
Arms of the Study
Arm 1
Experimental
Treatment (oxaliplatin plus topotecan)
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.