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

AEterna Zentaris85 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Cancer Endometrial Cancer

Interventions

AEZS-108DRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

University Hospital "Dr. Georgy Stranski"

Pleven, Bulgaria

Regional Oncology Hospital Plovdiv

Outcomes

Primary Outcomes

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

Secondary Outcomes

Time-to-progression (TTP); Overall survival

Time frame: up to observation of event

Safety of AEZS-108 (possibly drug-related adverse events)

Time frame: 4 weeks beyond last drug admnistration

Data from ClinicalTrials.gov

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