Overview

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