Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

Multicenter, Prospective Phase-I/II-study: Topotecan and Carboplatin in the Therapy of Patients With Relapsed Ovarian Cancer

Compatibility of the topotecan therapy in combination with carboplatin.

The aim of the study was to confirm the tolerability of 3-day topotecan therapy in combination with carboplatin in accordance with published data and to investigate the tolerability of continued therapy until disease progression or up to a maximum of 12 months.

Inclusion Criteria:

• Age >= 18 years
• patient with ovarian cancer after primary therapy
• bone marrow function leukocytes >= 4,0 x 109/ l, platelets >= 100 109/l, hemoglobin >= 9 g/dl
• renal function creatinin <= 1,5 mg% or creatinin clearance >= 60 ml/min
• liver function bilirubin <= 2,0 mg/dl, SGOT, SGPT and AP within 3 fold of the reference laboratory's normal range
• ECOG <= 2
• Intention of regular follow-up visits for the duration of the study
• written informed consent

Exclusion Criteria:

• any known hypersensitivity against topotecan isomerase-I-inhibitor other medication included in the study protocol
• ECOG > 2
• patients with radiotherapy within the last 4 weeks