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Pancrelipase

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Xylometazoline

Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

STA-9090

radiologic modalities used to evaluate response to treatment

Radiologic imaging

Venous blood will be drawn from those patients who give consent. Serum will be used to look for biomarkers predictive of response

blood draw

Dana Cardin, MD

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.

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.

PhII Study STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer

Phase II Study of STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer

Serum will be tested for biomarkers that may be predictive of response, optional per patient consent.

Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions, and progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions. Disease control is defined as CR + PR + SD after 8 weeks of therapy.

Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), \>=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD.

Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details)

Count of patients according to the worst-grade toxicity experienced by each, where worst-grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; grade 5, death

National Cancer Institute (NCI)

Vanderbilt-Ingram Cancer Center

Assistant Professor of Medicine; Medical Oncologist

175 mg/m2 STA-9090 IV over 1 hour once a week for 3 weeks, followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression.

175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Dana Cardin

Patients who received treatment and who were available for determination of response.

Disease Control Rate

Complete response

Partial response

Stable disease

Progressive disease

Not Assessed

Not Evaluable

All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non-evaluable for best overall response.

Best Response

All patients are included in the analysis on intention-totreat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.

Overall Survival

Patients with worst grade toxicity 1

Patients with worst grade toxicity 2

Patients with worst grade toxicity 3

Patients with worst grade toxicity 4

Patients with worst grade toxicity 5

Total number of patients reported with any toxicity related to study treatment. One patient withdrew before treatment. One patient did not have a toxicity related to study drug or therapy.

Number of Patients With Each Worst Grade Toxicity

The study's interim analysis found the study drug to be ineffective. The study was terminated. No biomarkers were performed or analyzed.

Spots Global Cancer Trial Database for radiologic imaging