A Phase I/II Trial of AEZS-108 in Urothelial Cancer Patients Who Failed Platinum-chemotherapy

• Status: Terminated
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the appropriate dose of AEZS-108 to treat patients with a tumor of the urinary system.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AEterna Zentaris
• Collaborators: Miami VA Healthcare System; University of Miami; University of Miami Sylvester Comprehensive Cancer Center
• Treatments: Doxorubicin; Prolactin Release-Inhibiting Factors

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma

• Expression of LHRH receptors confirmed by immunohistochemistry on archival cancer tissue

• Measurable disease on radiological studies

• Patients with Locally advanced unresectable or metastatic urothelial carcinoma

• Documented progression on at least one prior chemotherapy regimen which must have incorporated platinum based therapy

• Left ventricular ejection fraction (EF) > 50%

• Eastern cooperative oncology group (ECOG) status of 0, 1 or 2

• Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

• Prior treatment with or allergy to any components of AEZS-108

• Active second malignancies other than non-melanoma skin cancers

• Ongoing use of an LHRH agonist (or antagonist)

• Presence of an active infection or fever > 38.5 C, parenchymal brain metastases or uncontrolled intercurrent illness

• Prior exposure to anthracyclines or anthracenediones including doxorubicin, daunorubicin, and mitoxantrone

• Patients who received radiotherapy within 4 weeks of entry

• Major surgery within the last 4 weeks and minor surgery in last 7 days