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Randomized Controlled Study Comparing AEZS-108 With Doxorubicin as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer.
Description
Phase
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.
Inclusion and Exclusion Criteria
- Women ≥ 18 years of age
- Histologically confirmed endometrial cancer
- Advanced (FIGO stage III or IV), recurrent or metastatic disease.
- Measurable or non-measurable disease that has progressed since last treatment.
- Patients with advanced, recurrent or metastatic endometrial cancer who have received one chemotherapeutic regimen with platinum and taxane (either as adjuvant or as first line treatment) and who have progressed.
- Availability of fresh or archival FFPE tumor specimens for analysis of LHRH receptor expression.
- ECOG performance status > 2.
- Inadequate hematologic, hepatic or renal function
- Red blood cell transfusion within 2 weeks prior to anticipated start of study treatment.
- History of myocardial infarction, acute inflammatory heart disease, unstable angina, or uncontrolled arrhythmia within the past 6 months.
- Impaired cardiac function defined as left ventricular ejection fraction (LVEF) < 50 % (or below the study site's lower limit of normal) as measured by MUGA or ECHO.
- Concomitant use of prohibited therapy (specified in protocol)
- Chemo-, immune-, or hormone-therapy within 5 elimination half life times or 4 weeks prior to randomization, whichever is the shorter. Radiotherapy (including pre- or post-operative brachytherapy) within 4 weeks prior to randomization.
- Previous anthracycline-based chemotherapy (daunorubicin, doxorubicin, epirubicin, idarubicin, mitoxantrone and valrubicin), in any formulation.
- Anticipated ongoing concomitant anticancer therapy during the study.
- History of serious co-morbidity or uncontrolled illness that would preclude study therapy, such as active tuberculosis or any other active infection.
- Brain metastasis, leptomeningeal disease.
- Pregnant or lactating female or female of child-bearing potential not employing adequate contraception.
- Subjects with known hypersensitivity to peptide drugs, including LHRH agonists.
- Receipt of 2 or more prior cytotoxic chemotherapy regimens for advanced, recurrent, or metastatic endometrial cancer.
- Prior treatment with AEZS-108.
- Use of LHRH agonist or antagonist treatment within 6 months prior to randomization.
- Malignancy within last 5 years except non-melanoma skin cancer.
- Any concomitant disease or condition which would interfere with the subjects' proper completion of the protocol assignment.
- Concomitant or recent treatment with other investigational drug (within 4 weeks or 5 elimination half life times prior to anticipated start of study treatment).
- Lack of ability or willingness to give informed consent.
- Anticipated non-availability for study visits/procedures.
Sites
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California
- USC Norris Hospital and LAC+USC Medical Center, Los Angeles, California, 90033
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Arizona
- St. Joseph's Hospital and Medical Center, Phoenix, Arizona, 85013
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Colorado
- University of Colorado, Aurora, Colorado, 80045
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Oklahoma
- Peggy and Charles Oklahoma Cancer Center, Oklahoma City, Oklahoma, 73104
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South Dakota
- Sanford Research/USD, Sioux Falls, South Dakota, 57104
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North Dakota
- Roger Maris Cancer Center, Fargo, North Dakota, 58122
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Iowa
- University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242
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Missouri
- Washington University School of Medecine, St Louis, Missouri, 63110
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Louisiana
- Women's Cancer Center, Covington, Louisiana, 70433
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Wisconsin
- Froedtert & The Medical College of Wisconsin, Inc., Milwaukee, Wisconsin, 53226
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Illinois
- Northwestern University, Chicago, Illinois, 60611
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Georgia
- Northside Hospital, Atlanta, Georgia, 30342
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Italy
- Istituto Nazionale Tumori IRCCS, Napoli, 80131
- Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari, Bari, 70124
- Istituto Oncologico Veneto, IRCCS, Padova, 35128
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Israel
- Barzilai Medical Center, Ashkelon, 78278
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Czech Republic
- Fakultní nemocnice Olomouc, Olomouc, 77520
- Masarykův onkologický ústav, Brno, 65653
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Ukraine
- Public health enterprise "Kharkov regional Clinical Oncological Center", Kharkov, 61070
- Municipal institution "Dnipropetrovsk City Multidisciplinary Clinical Hospital No. 4", Dnepropetrovsk, 49102
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