PhII Study STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer
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.
Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer
Radiation: Radiologic imaging
Procedure: blood draw
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer|
- Disease Control Rate [ Time Frame: at 8 weeks from the start of therapy ] [ Designated as safety issue: No ]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.
- Best Response [ Time Frame: On-treatment date, to date of disease progression (assessed up to 1 year) ] [ Designated as safety issue: No ]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.
- Overall Survival [ Time Frame: study entry to date of death or last date known alive (assessed over 2.5 yrs) ] [ Designated as safety issue: No ]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)
- Number of Patients With Each Worst Grade Toxicity [ Time Frame: On study date to 30 days following final dose of study drug ] [ Designated as safety issue: Yes ]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
- Biomarker Evaluation [ Time Frame: Pre-treatment and 1 week post-treatment ] [ Designated as safety issue: No ]Serum will be tested for biomarkers that may be predictive of response, optional per patient consent.
|Study Start Date:||December 2010|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
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.
Given IVRadiation: Radiologic imaging
radiologic modalities used to evaluate response to treatment
Other Names:Procedure: blood draw
Venous blood will be drawn from those patients who give consent. Serum will be used to look for biomarkers predictive of response
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227018
|United States, Tennessee|
|The Jones Clinic|
|Memphis, Tennessee, United States, 38138|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Dana Cardin, MD||Vanderbilt-Ingram Cancer Center|