Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

Phase 1

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Hycamtin

• Registration Number: NCT00170625
• Lead Sponsor: North Eastern German Society of Gynaecological Oncology

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

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2005-08
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Results First Submitted: 2016-10-04
• Results First Submitted QC: 2016-12-13
• Results First Posted: 2017-02-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Relapse 6-12 months	Hycamtin	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.
Relapse >12 months	Hycamtin	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.

Primary Outcome Measures

Name	Time	Method
Occurrence of a DLT (Dose Limiting Toxicity)	after each cycle for up to one year	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.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	after every third cycle, for up to one year	Progression-free survival according to kaplan-meier-estimator