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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Endometrial Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tumor response as per RECIST or (for Ovarian CA patients without evaluable target lesion following RECIST) GCIG criteria

Outcome Time Frame:

up to six 3-weekly treatment cycles

Safety Issue:

No

Principal Investigator

Günter Emons, Prof.Dr.med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitäts-Frauenklinik / Department of Obstetrics and Gynecology, University of Göttingen

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

AEZS-108-040

NCT ID:

NCT00569257

Start Date:

December 2007

Completion Date:

July 2011

Related Keywords:

  • Ovarian Cancer
  • Endometrial Cancer
  • LHRH receptor
  • receptor positive tumors
  • platinum resistant ovarian cancer
  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Adenoma

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