Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

N

North Eastern German Society of Gynaecological Oncology

Status and phase

Completed
Phase 2
Phase 1

Conditions

Ovarian Cancer

Treatments

Drug: Hycamtin

Study type

Interventional

Funder types

Other

Identifiers

NCT00170625
310300

Details and patient eligibility

About

Compatibility of the topotecan therapy in combination with carboplatin.

Enrollment

28 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

28 participants in 1 patient group

Hycamtin
Experimental group
Treatment:
Drug: Hycamtin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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