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

NOGGO ov7

Details and patient eligibility

About

Compatibility of the topotecan therapy in combination with carboplatin.

Full 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 therapy until disease progression or up to a maximum of 12 months.

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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Relapse 6-12 months

Experimental group

Description:

dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application) If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)) A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.

Treatment:

Drug: Hycamtin

Relapse >12 months

Experimental group

Description:

dose level 0: Topotecan 1mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application) If dose limiting toxicity (DLT) is present then Topotecan dose will be reduced to dose level -1 (dose level -1: Topotecan 0.75 mg/m2/d on day 1-3, q 21d (+ Carboplatin AUC 5 on day 3 after Topotecan application)) A DLT is present if a patient has a postponement due to hematologic toxicity of more than 7 days within the first four courses at dose level 0.

Treatment:

Drug: Hycamtin