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

Sponsors and Collaborators:	AEterna Zentaris AGO Ovarian Cancer Study Group
Information provided by:	AEterna Zentaris
ClinicalTrials.gov Identifier:	NCT00569257

Purpose

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)

Condition	Intervention	Phase
Ovarian Cancer Endometrial Cancer	Drug: AEZS-108	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Gonadorelin Gonadorelin hydrochloride LH-RH

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Antitumoral Activity and Safety of AEZS-108 (AN-152), a LHRH Agonist Linked Doxorubicin, in Women With LHRH Receptor Positive Gynecological Tumors

Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time-to-progression (TTP); Overall survival [ Time Frame: up to observation of event ] [ Designated as safety issue: No ]
Safety of AEZS-108 (possibly drug-related adverse events) [ Time Frame: 4 weeks beyond last drug admnistration ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	82
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569257

Contacts

Contact: Andriy Markivskyy, Dr. med.	+49 69 42602 3270	amarkivskyy@aezsinc.com
Contact: Gabriele Elser	+49 611 88 04 67 20	gelser@ago-ovar.de

Locations

Bulgaria
University Hospital "Dr. Georgy Stranski"	Recruiting
Pleven, Bulgaria, BG-5800
Principal Investigator: Grigor Gorchev, Prof. Dr.
Germany
Klinik für Frauenheilkunde und Geburtshilfe, Charité Campus Virchow-Klinikum	Recruiting
Berlin, Germany, D-13353
Principal Investigator: Jalid Sehouli, Prof.Dr.med.
Frauenklinik, Klinikum Bremen-Mitte GmbH	Recruiting
Bremen, Germany, D-28177
Contact: Willibald Schröder, MD, Prof.
Principal Investigator: Willibald Schröder, Prof.Dr.med.
Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Carl Gustav Carus	Recruiting
Dresden, Germany, D-01307
Principal Investigator: Ulrich Canzler, Dr. med.
Klinik für Frauenheilkunde, Universität Erlangen-Nürnberg	Recruiting
Erlangen, Germany, D-91094
Principal Investigator: Matthias Beckmann, Prof.Dr.med.
Universitätsfrauenklinik, Universitätsklinikum	Recruiting
Essen, Germany, D-45122
Principal Investigator: Pauline Wimberger, Dr. med.
Universitätsfrauenklinik, Klinikum der JWG Universität Frankfurt	Recruiting
Frankfurt / Main, Germany, D-60591
Principal Investigator: Lars Hanker, Dr. med.
Klinikum der Ernst-Moritz-Arndt-Universitaet, Klinik und Poliklinik fuer Gynaekologie und Geburtshilfe	Not yet recruiting
Greifswald, Germany, D-17487
Principal Investigator: Antje-Kristina Belau, Dr. med.
Frauenklinik, Medizinische Hochschule Hannover	Recruiting
Hannover, Germany, D-30625
Principal Investigator: Peter Hillemanns, Prof.Dr.med.
Frauenklinik, St. Vincentius Kliniken AG	Recruiting
Karlsruhe, Germany, D-76135
Principal Investigator: Anne Stähle, Dr. med.
Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Campus Kiel	Recruiting
Kiel, Germany, D-24105
Principal Investigator: Felix Hilpert, Dr. med.
Frauenklinik, Klinikum Lüneburg	Recruiting
Lüneburg, Germany, D-21339
Principal Investigator: Peter Dall, Prof.Dr.med.
Klinik f. Gynäkologie u. Gyn. Onkologie, Dr. Horst Schmidt Kliniken GmbH	Recruiting
Wiesbaden, Germany, D-65199
Principal Investigator: Philipp Harter, Dr. med.
Klinikum Suedstadt der Hansestadt Rostock, Universitaetsfrauenklinik und Poliklinik	Recruiting
Rostock, Germany, D-18059
Principal Investigator: Bernd Gerber, Prof.Dr.med.
Frauenklinik, Georg-August-Universität Göttingen	Recruiting
Göttingen, Germany, D-37075
Principal Investigator: Günter Emons, Prof.Dr.med.

Sponsors and Collaborators

AEterna Zentaris

AGO Ovarian Cancer Study Group

Investigators

Principal Investigator:

Günter Emons, Prof.Dr.med.

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

More Information

AGO Studiengruppe Ovarialkarzinom This link exits the ClinicalTrials.gov site

Responsible Party:	Æterna Zentaris ( Andriy Markivskyy, MD )
Study ID Numbers:	AEZS-108-040, AGO-GYN 5, EudraCT No. 2007-002663-26
Study First Received:	December 6, 2007
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00569257
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AEterna Zentaris:

LHRH receptor
receptor positive tumors
platinum resistant ovarian cancer

Study placed in the following topic categories:

Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Uterine Diseases
Urogenital Neoplasms
Ovarian Diseases

Doxorubicin
Genital Diseases, Female
Endometrial Neoplasms
Uterine Neoplasms
Endocrinopathy
Endometrial cancer
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 15, 2009