Study Comparing AEZS-108/ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) to Doxorubicin as a Second Line Therapy of Endometrial Cancer

Status: Recruiting
Phase: Phase 3
Diagnosis: GYN: Endometrial/Uterine Cancer
NCT ID: NCT01767155 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-520

 

Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin. The study will include about 500 patients with endometrial cancer resistant to platinum/taxane-based chemotherapy.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Don Dizon, MD, Massachusetts General Hospital

Site-responsible Investigators:
Susana Campos, MD, Dana-Farber Cancer Institute
Mary Buss, MD, Beth Israel Deaconess Medical Center

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Christin Whalen, cwhalen@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: 1. Women ≥ 18 years of age 2. Histologically confirmed endometrial cancer 3. Advanced (FIGO stage III or IV), recurrent or metastatic disease. 4. Measurable or non-measurable disease that has progressed since last treatment. 5. Patients who have progressed after prior first line treatment with platinum/taxane based chemotherapy for advanced, recurrent or metastatic endometrial cancer. 6. Availability of fresh or archival FFPE tumor specimens for analysis of LHRH receptor expression. Exclusion Criteria: 1. ECOG performance status > 2. 2. Inadequate hematologic, hepatic or renal function 3. Red blood cell transfusion within 2 weeks prior to anticipated start of study treatment. 4. History of myocardial infarction, unstable angina, or uncontrolled arrhythmia within the past 6 months. 5. Impaired cardiac function defined as left ventricular ejection fraction (LVEF) < 50 % as measured by MUGA or ECHO. 6. Planned concomitant use of potentially cardiotoxic medication 7. Chemo-, immune-, hormone-, or radiotherapy (including pre- or post-operative brachytherapy) within 4 weeks prior to randomization. 8. Previous anthracycline-based chemotherapy. 9. Anticipated ongoing concomitant anticancer therapy during the study. 10. History of serious co-morbidity or uncontrolled illness that would preclude study therapy, such as active tuberculosis or any other active infection. 11. Brain metastasis, leptomeningeal disease. 12. Pregnant or lactating female or female of child-bearing potential not employing adequate contraception. 13. Receipt of 2 or more prior chemotherapy regimens for advanced, recurrent, or metastatic endometrial cancer. 14. Prior treatment with AEZS-108. 15. Use of LHRH agonist or antagonist treatment within 6 months prior to randomization. 16. Malignancy within last 5 years except non-melanoma skin cancer. 17. Any concomitant disease or condition which would interfere with the subjects' proper completion of the protocol assignment. 18. Concomitant or recent treatment with other investigational drug (within 8 weeks or 5 elimination half life times prior to anticipated start of study treatment). 19. Lack of ability or willingness to give informed consent. 20. Anticipated non-availability for study visits/procedures.
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