Hycamtin Plus Carboplatin Versus Established Regimens for the Treatment of Ovarian Cancer Relapse

Phase 3

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Topotecan

• Registration Number: NCT00437307
• Lead Sponsor: North Eastern German Society of Gynaecological Oncology

Brief Summary

Determination of progression free survival after 12 months of FU

Determination of total survival, response and quality of life

Detailed Description

In Germany there are two established therapy regimes for platin sensitive ovarian cancer: the combination of carboplatin and paclitaxel as well as the combination of carboplatin with gemcitabine. Choice of therapy is individual due to missing randomized comparisons between the regimes. Topotecan has shown good efficacy in second-line therapy of ovarian cancer as well as a good, especially, non-hematoxic toxicity profile. Several phase II-studies have demonstrated a synergistic effect of topotecan in combination with carboplatin exhibiting good efficacy and tolerability.

It shall be tested in this randomized phase III-study if the combination of topotecan and carboplatin shows improvement of progression-free survival in comparison to the standard regimes.

Study Timeline

• Study First Submitted: 2007-02-19
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-21
• Study Start: 2007-03
• Primary Completion: 2013-07
• Study Completion: 2015-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-21
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 550

Inclusion Criteria

• Women ≥18 years of age with platinum-sensitive recurrent ovarian cancer occurring at least six months after completion of primary standard therapy are eligible
• Patients with measurable or assessable lesions or CA-125 ≥ 2x ULN an Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2
• All patients will provide written informed consent

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Exclusion Criteria

• Patients with more than two chemotherapies in their history
• Progress less than six months after completion of primary standard therapy
• Simultaneous or planned radiation
• Any known hypersensitivity to topotecan, carboplatin, paclitaxel or gemcitabine
• Patients with infection
• Patients who are pregnant or breast feeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Topotecan	Topotecan: 0,75 mg/m²/d, Tage 1-3 und Carboplatin: AUC 5 (after Cockroft and Gault formula) am Tag 3 nach Topotecan, q 21d.

Primary Outcome Measures

Name	Time	Method
progression-free survival	after 1 year-follow-up

Secondary Outcome Measures

Name	Time	Method
overall survival, efficacy and tolerability of the regimes and quality of life	during study and follow-up

Trial Locations

Locations (1)

Charité Campus Virchow Klinikum; 🇩🇪 Berlin, Germany