Status:

COMPLETED

Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

Lead Sponsor:

North Eastern German Society of Gynaecological Oncology

Conditions:

Ovarian Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

Compatibility of the topotecan therapy in combination with carboplatin.

Detailed Description

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 thera...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT00170625

Start Date

June 1 2004

Last Update

November 12 2024

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