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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ovarian Cancer, Endometrial Cancer

Intervention / Treatment
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* Drug: AEZS-108


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-progression (TTP); Overall survival |  | up to observation of event | 
| Safety of AEZS-108 (possibly drug-related adverse events) |  | 4 weeks beyond last drug admnistration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LHRH receptor, receptor positive tumors, platinum resistant ovarian cancer