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Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological Tumors

Primary Purpose

Ovarian Cancer, Endometrial Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

AEZS-108

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring LHRH receptor, receptor positive tumors, platinum resistant ovarian cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

LHRH receptor positive tumor status: positive receptor status determined by immunohistochemistry from primary tumor
Histologically confirmed epithelial ovarian cancer (Stratum A)
Advanced (FIGO III or IV) or recurrent disease
Progression during treatment with a platinum-based regimen or within 6 months after receiving a platinum-based regimen
Previous treatment with a taxane-containing regimen
At least one measurable target lesion (RECIST criteria) OR CA125 level higher than twice the upper limit of normal range (GCIG criteria)
Histologically confirmed endometrial cancer (Stratum B)
Advanced (FIGO III or IV) or recurrent disease not amenable to potentially curative treatment with local surgery and/or radiation therapy
No previous anthracycline-based chemotherapy
At least one measurable target lesion according to RECIST criteria

Sites / Locations

University Hospital "Dr. Georgy Stranski"
Regional Oncology Hospital Plovdiv
Regional Oncodispensary "M.Markov"
Klinik für Frauenheilkunde und Geburtshilfe, Charité Campus Virchow-Klinikum
Frauenklinik, Klinikum Bremen-Mitte GmbH
Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Carl Gustav Carus
Klinik für Frauenheilkunde, Universität Erlangen-Nürnberg
Universitätsfrauenklinik, Universitätsklinikum
Universitätsfrauenklinik, Klinikum der JWG Universität Frankfurt
Klinikum der Ernst-Moritz-Arndt-Universitaet, Klinik und Poliklinik fuer Gynaekologie und Geburtshilfe
Frauenklinik, Georg-August-Universität Göttingen
Frauenklinik, Medizinische Hochschule Hannover
Frauenklinik, St. Vincentius Kliniken AG
Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Campus Kiel
Frauenklinik, Klinikum Lüneburg
Klinikum Suedstadt der Hansestadt Rostock, Universitaetsfrauenklinik und Poliklinik
Klinik f. Gynäkologie u. Gyn. Onkologie, Dr. Horst Schmidt Kliniken GmbH

Outcomes

Primary Outcome Measures

Tumor response as per RECIST or (for Ovarian CA patients without evaluable target lesion following RECIST) GCIG criteria

Secondary Outcome Measures

Time-to-progression (TTP); Overall survival

Safety of AEZS-108 (possibly drug-related adverse events)

Full Information

NCT ID

NCT00569257

First Posted

December 6, 2007

Last Updated

December 12, 2011

Sponsor

AEterna Zentaris

Collaborators

AGO Study Group

1. Study Identification

Unique Protocol Identification Number

NCT00569257

Brief Title

Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological Tumors

Official Title

Antitumoral Activity and Safety of AEZS-108 (AN-152), a LHRH Agonist Linked Doxorubicin, in Women With LHRH Receptor Positive Gynecological Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AEterna Zentaris

Collaborators

AGO Study Group

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether AEZS-108 shows anti-tumor activity and is tolerated in patients with gynecological tumors (ovarian / endometrial cancer) that have been shown to express receptors for the luteinizing hormone releasing hormone (LHRH)

Detailed Description

The ovary and the endometrium are hormone dependent organs. Receptors for different sex hormones are found commonly in epithelial ovarian and endometrial cancers. LHRH and its receptors are expressed in about 80% of human ovarian and endometrial cancers. As binding sites are present on tumors in higher concentrations than on most normal tissues, these receptors represent a specific target for AEZS-108 in which doxorubicin is coupled to an LHRH analog. Patients whose tumor specimen have shown to be positive for LHRH receptor expression will be investigated for tumor response and tolerability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer, Endometrial Cancer

Keywords

LHRH receptor, receptor positive tumors, platinum resistant ovarian cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

85 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

AEZS-108

Other Intervention Name(s)

AN-152

Intervention Description

intravenous infusion at a dose of 267 mg/sqm every 3 weeks, up to 6 treatment cycles

Primary Outcome Measure Information:

Title

Tumor response as per RECIST or (for Ovarian CA patients without evaluable target lesion following RECIST) GCIG criteria

Time Frame

up to six 3-weekly treatment cycles

Secondary Outcome Measure Information:

Title

Time-to-progression (TTP); Overall survival

Time Frame

up to observation of event

Title

Safety of AEZS-108 (possibly drug-related adverse events)

Time Frame

4 weeks beyond last drug admnistration

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: LHRH receptor positive tumor status: positive receptor status determined by immunohistochemistry from primary tumor Histologically confirmed epithelial ovarian cancer (Stratum A) Advanced (FIGO III or IV) or recurrent disease Progression during treatment with a platinum-based regimen or within 6 months after receiving a platinum-based regimen Previous treatment with a taxane-containing regimen At least one measurable target lesion (RECIST criteria) OR CA125 level higher than twice the upper limit of normal range (GCIG criteria) Histologically confirmed endometrial cancer (Stratum B) Advanced (FIGO III or IV) or recurrent disease not amenable to potentially curative treatment with local surgery and/or radiation therapy No previous anthracycline-based chemotherapy At least one measurable target lesion according to RECIST criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Günter Emons, Prof.Dr.med.

Organizational Affiliation

Universitäts-Frauenklinik / Department of Obstetrics and Gynecology, University of Göttingen

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital "Dr. Georgy Stranski"

City

Pleven

ZIP/Postal Code

BG-5800

Country

Bulgaria

Facility Name

Regional Oncology Hospital Plovdiv

City

Plovdiv

ZIP/Postal Code

BG-4002

Country

Bulgaria

Facility Name

Regional Oncodispensary "M.Markov"

City

Varna

ZIP/Postal Code

BG-9010

Country

Bulgaria

Facility Name

Klinik für Frauenheilkunde und Geburtshilfe, Charité Campus Virchow-Klinikum

City

Berlin

ZIP/Postal Code

D-13353

Country

Germany

Facility Name

Frauenklinik, Klinikum Bremen-Mitte GmbH

City

Bremen

ZIP/Postal Code

D-28177

Country

Germany

Facility Name

Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Carl Gustav Carus

City

Dresden

ZIP/Postal Code

D-01307

Country

Germany

Facility Name

Klinik für Frauenheilkunde, Universität Erlangen-Nürnberg

City

Erlangen

ZIP/Postal Code

D-91094

Country

Germany

Facility Name

Universitätsfrauenklinik, Universitätsklinikum

City

Essen

ZIP/Postal Code

D-45122

Country

Germany

Facility Name

Universitätsfrauenklinik, Klinikum der JWG Universität Frankfurt

City

Frankfurt / Main

ZIP/Postal Code

D-60591

Country

Germany

Facility Name

Klinikum der Ernst-Moritz-Arndt-Universitaet, Klinik und Poliklinik fuer Gynaekologie und Geburtshilfe

City

Greifswald

ZIP/Postal Code

D-17487

Country

Germany

Facility Name

Frauenklinik, Georg-August-Universität Göttingen

City

Göttingen

ZIP/Postal Code

D-37075

Country

Germany

Facility Name

Frauenklinik, Medizinische Hochschule Hannover

City

Hannover

ZIP/Postal Code

D-30625

Country

Germany

Facility Name

Frauenklinik, St. Vincentius Kliniken AG

City

Karlsruhe

ZIP/Postal Code

D-76135

Country

Germany

Facility Name

Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Campus Kiel

City

Kiel

ZIP/Postal Code

D-24105

Country

Germany

Facility Name

Frauenklinik, Klinikum Lüneburg

City

Lüneburg

ZIP/Postal Code

D-21339

Country

Germany

Facility Name

Klinikum Suedstadt der Hansestadt Rostock, Universitaetsfrauenklinik und Poliklinik

City

Rostock

ZIP/Postal Code

D-18059

Country

Germany

Facility Name

Klinik f. Gynäkologie u. Gyn. Onkologie, Dr. Horst Schmidt Kliniken GmbH

City

Wiesbaden

ZIP/Postal Code

D-65199

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.ago-ovar.de

Description

AGO Studiengruppe Ovarialkarzinom

Learn more about this trial

Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological Tumors

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