Clinical trial NCT00569257: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Endometrial Cancer
Keywords: LHRH receptor
receptor positive tumors
platinum resistant ovarian cancer
Lead sponsor: AEterna Zentaris
Sponsor class: INDUSTRY
Collaborators: name: AGO Study Group
First posted: 2007-12-07
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Tumor response as per RECIST or (for Ovarian CA patients without evaluable target lesion following RECIST) GCIG criteria
timeFrame: up to six 3-weekly treatment cycles
Secondary outcomes:
measure: Time-to-progression (TTP); Overall survival
timeFrame: up to observation of event
measure: Safety of AEZS-108 (possibly drug-related adverse events)
timeFrame: 4 weeks beyond last drug admnistration
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: University Hospital "Dr. Georgy Stranski"
city: Plovdiv
country: Bulgaria
facility: Regional Oncology Hospital Plovdiv
city: Varna
country: Bulgaria
facility: Regional Oncodispensary "M.Markov"
city: Berlin
country: Germany
facility: Klinik für Frauenheilkunde und Geburtshilfe, Charité Campus Virchow-Klinikum
city: Bremen
country: Germany
facility: Frauenklinik, Klinikum Bremen-Mitte GmbH
city: Dresden
country: Germany
facility: Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Carl Gustav Carus
city: Erlangen
country: Germany
facility: Klinik für Frauenheilkunde, Universität Erlangen-Nürnberg
city: Essen
country: Germany
facility: Universitätsfrauenklinik, Universitätsklinikum
city: Frankfurt / Main
country: Germany
facility: Universitätsfrauenklinik, Klinikum der JWG Universität Frankfurt
city: Greifswald
country: Germany
facility: Klinikum der Ernst-Moritz-Arndt-Universitaet, Klinik und Poliklinik fuer Gynaekologie und Geburtshilfe
city: Göttingen
country: Germany
facility: Frauenklinik, Georg-August-Universität Göttingen
city: Hannover
country: Germany
facility: Frauenklinik, Medizinische Hochschule Hannover
city: Karlsruhe
country: Germany
facility: Frauenklinik, St. Vincentius Kliniken AG
city: Kiel
country: Germany
facility: Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Lüneburg
country: Germany
facility: Frauenklinik, Klinikum Lüneburg
city: Rostock
country: Germany
facility: Klinikum Suedstadt der Hansestadt Rostock, Universitaetsfrauenklinik und Poliklinik
city: Wiesbaden
country: Germany
facility: Klinik f. Gynäkologie u. Gyn. Onkologie, Dr. Horst Schmidt Kliniken GmbH
Study officials:
affiliation: Universitäts-Frauenklinik / Department of Obstetrics and Gynecology, University of Göttingen
name: Günter Emons, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: