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

Ovarian Cancer Clinical Trial

— HECTOR  

Official title:

Topotecan Plus Carboplatin im Vergleich Zur Standardtherapie (Paclitaxel Plus Carboplatin Oder Gemcitabin Plus Carboplatin) in Der Therapie Von Patientinnen Mit Platin-sensitivem Rezidivierten Epithelialen Ovarialkarzinom, Peritonealkarzinom Oder Tubenkarzinom

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437307
• Other study ID #: 3104000
• Status: Completed
• Phase: Phase 3
• First received: February 19, 2007
• Last updated: September 21, 2016
• Start date: March 2007
• Est. completion date: June 2015

Study information

• Verified date: September 2016
• Source: North Eastern Germany Society of Gynaecologic Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Determination of progression free survival after 12 months of FU

Determination of total survival, response and quality of life

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: June 2015
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Topotecan
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

Locations

Country	Name	City	State
Germany	Charité Campus Virchow Klinikum	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
North Eastern Germany Society of Gynaecologic Oncology

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		after 1 year-follow-up	No
Secondary	overall survival, efficacy and tolerability of the regimes and quality of life		during study and follow-up	Yes