Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Carcinoma

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