Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Compatibility of the topotecan therapy in combination with carboplatin.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: North Eastern German Society of Gynaecological Oncology; North Eastern Germany Society of Gynaecologic Oncology
• Treatments: Carboplatin; Topotecan

Criteria

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