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Brief Title: PhII Study STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer
Official Title: Phase II Study of STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer
Study ID: NCT01227018
Brief Summary: RATIONALE: Heat shock protein (HSP)90 inhibitor STA-9090 may stop the growth of tumor cells by blocking some of the proteins needed for cell growth. PURPOSE: This phase II trial is studying how well hsp90 inhibitor STA-9090 works as second- or third-line therapy for the treatment of patients with metastatic pancreatic cancer.
Detailed Description: PRIMARY OBJECTIVES: I. To measure the 8-week disease control (CR + PR + SD) rate of therapy with STA-9090 in patients with metastatic pancreas cancer who have failed (either progressed or did not tolerate) one or two lines of prior therapy. SECONDARY OBJECTIVES: I. To determine response rate (by RECIST criteria v1.1). II. To determine overall survival. III. To evaluate the safety and toxicity profile in this patient population. TERTIARY OBJECTIVES: I. We will obtain from all patients blood samples pre and post therapy (after 1 week of therapy) and isolate serum for interrogation for a variety of biomarkers (eg AKT, Stat3, Caspase 3). OUTLINE: Patients receive Hsp90 inhibitor STA-9090 intravenous (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 4 weeks.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Jones Clinic, Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Name: Dana Cardin, MD
Affiliation: Vanderbilt-Ingram Cancer Center
Role: PRINCIPAL_INVESTIGATOR