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

North Eastern German Society of Gynaecological Oncology550 enrolled

Overview

Determination of progression free survival after 12 months of FU Determination of total survival, response and quality of life

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

550

Conditions

Ovarian Cancer

Interventions

TopotecanDRUG

Topotecan: 0,75 mg/m²/d, day 1-3, and Carboplatin: AUC 5 (after Cockroft and Gault Formula) on day 3 after Topotecan, q 21d

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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 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

Locations (1)

Charité Campus Virchow Klinikum

Berlin, Germany

Outcomes

Primary Outcomes

progression-free survival

Time frame: after 1 year-follow-up

Secondary Outcomes

overall survival, efficacy and tolerability of the regimes and quality of life

Time frame: during study and follow-up

Data from ClinicalTrials.gov

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