Weekly Administration of Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer
Inclusion Criteria:
- Histologically or cytologically confirmed ovarian adenocarcinoma
- Patients had to have received a front-line, platinum- based chemotherapy regimen
- Patients who progressed or whose best response to their most recent platinum-based
therapy was less than a partial response will be classified as having
platinum-refractory/resistant ovarian cancer. This category also will include
patients with disease progression within six months of completing the most recent
platinum-based chemotherapy
- Patients had to have at least one bidimensionally measurable and/or evaluable
(unidimensionally measurable) target lesion in a non-irradiated area, or increased Ca
125
- A >= 4 weeks interval between their last chemotherapy regimen and the start of study
treatment
- Age > 18 years old
- Performance status (WHO) 0-2
- Life expectancy of at least three months
- Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count
> 100000/mm^3, hemoglobin > 9 gr/mm^3)
- Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times
upper limit of normal) and renal function (creatinine < 2 mg/dl)
- Informed consent
Exclusion Criteria:
- Pregnant or nursing
- Psychiatric illness or social situation that would preclude study compliance
- Other concurrent uncontrolled illness
- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer