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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569257
• Other study ID #: AEZS-108-040
• Secondary ID: AGO-GYN 5EudraCT
• Status: Completed
• Phase: Phase 2
• First received: December 6, 2007
• Last updated: December 12, 2011
• Start date: December 2007
• Est. completion date: July 2011

Study information

• Verified date: December 2011
• Source: AEterna Zentaris
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesBulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• AEZS-108
intravenous infusion at a dose of 267 mg/sqm every 3 weeks, up to 6 treatment cycles

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AEterna Zentaris	AGO Study Group

Countries where clinical trial is conducted

Bulgaria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor response as per RECIST or (for Ovarian CA patients without evaluable target lesion following RECIST) GCIG criteria		up to six 3-weekly treatment cycles	No
Secondary	Time-to-progression (TTP); Overall survival		up to observation of event	No
Secondary	Safety of AEZS-108 (possibly drug-related adverse events)		4 weeks beyond last drug admnistration	Yes

External Links

•   AGO Studiengruppe Ovarialkarzinom