Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

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)

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28 participants in 1 patient group

Hycamtin

Experimental group

Treatment:

Drug: Hycamtin