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

This study has been completed.
Sponsor:
Collaborator:
AGO Study Group
Information provided by (Responsible Party):
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT00569257
First received: December 6, 2007
Last updated: December 12, 2011
Last verified: December 2011
  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 2

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

Resource links provided by NLM:


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 ]

Enrollment: 85
Study Start Date: December 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AEZS-108
    intravenous infusion at a dose of 267 mg/sqm every 3 weeks, up to 6 treatment cycles
    Other Name: AN-152
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Bulgaria
University Hospital "Dr. Georgy Stranski"
Pleven, Bulgaria, BG-5800
Regional Oncology Hospital Plovdiv
Plovdiv, Bulgaria, BG-4002
Regional Oncodispensary "M.Markov"
Varna, Bulgaria, BG-9010
Germany
Klinik für Frauenheilkunde und Geburtshilfe, Charité Campus Virchow-Klinikum
Berlin, Germany, D-13353
Frauenklinik, Klinikum Bremen-Mitte GmbH
Bremen, Germany, D-28177
Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Carl Gustav Carus
Dresden, Germany, D-01307
Klinik für Frauenheilkunde, Universität Erlangen-Nürnberg
Erlangen, Germany, D-91094
Universitätsfrauenklinik, Universitätsklinikum
Essen, Germany, D-45122
Universitätsfrauenklinik, Klinikum der JWG Universität Frankfurt
Frankfurt / Main, Germany, D-60591
Klinikum der Ernst-Moritz-Arndt-Universitaet, Klinik und Poliklinik fuer Gynaekologie und Geburtshilfe
Greifswald, Germany, D-17487
Frauenklinik, Georg-August-Universität Göttingen
Göttingen, Germany, D-37075
Frauenklinik, Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Frauenklinik, St. Vincentius Kliniken AG
Karlsruhe, Germany, D-76135
Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, D-24105
Frauenklinik, Klinikum Lüneburg
Lüneburg, Germany, D-21339
Klinikum Suedstadt der Hansestadt Rostock, Universitaetsfrauenklinik und Poliklinik
Rostock, Germany, D-18059
Klinik f. Gynäkologie u. Gyn. Onkologie, Dr. Horst Schmidt Kliniken GmbH
Wiesbaden, Germany, D-65199
Sponsors and Collaborators
AEterna Zentaris
AGO Study Group
Investigators
Principal Investigator: Günter Emons, Prof.Dr.med. Universitäts-Frauenklinik / Department of Obstetrics and Gynecology, University of Göttingen
  More Information

Additional Information:
No publications provided

Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT00569257     History of Changes
Other Study ID Numbers: AEZS-108-040, AGO-GYN 5, EudraCT No. 2007-002663-26
Study First Received: December 6, 2007
Last Updated: December 12, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Bulgaria: Bulgarian Drug Agency

Keywords provided by AEterna Zentaris:
LHRH receptor
receptor positive tumors
platinum resistant ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014