Oxaliplatin and Topotecan in Advance Ovarian Cancer

Phase 2

Terminated

Brief Summary: This phase II trial is studying how well giving oxaliplatin together with topotecan works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as oxaliplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

Detailed Description: 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.

Recruitment & Eligibility

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Treatment (oxaliplatin plus topotecan)	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.
Treatment (oxaliplatin plus topotecan)	oxaliplatin	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.

Primary Outcome Measures

Name	Time	Method
Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)	Every two cycles for up to 24 weeks.	Tumor response was assessed every two cycles by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>= 30% decrease in the sum of the longest diameter (LD) of target lesions; Overall Response (OR) = CR + PR.

Secondary Outcome Measures

Name	Time	Method
Time to Disease Progression by RECIST and/or CA 125	Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeks	Time to disease progression by RECIST and/or CA 125