PhII Study STA-9090 As Second Or Third-Line Therapy For Metastatic Pancreas Cancer

Study Overview

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.

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.

Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer

DRUG: STA-9090
RADIATION: Radiologic imaging
PROCEDURE: blood draw

VICC GI 1016
NCI-2010-02123

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-10-20	Results First Submitted 2014-06-23	Last Update Submitted that met QC Criteria 2014-06-23
First Submitted that Met QC Criteria 2010-10-20	Results First Submitted that Met QC Criteria 2014-06-23	Last Update Posted (ESTIMATED) 2014-07-23
First Posted (ESTIMATED) 2010-10-22	Results First Posted 2014-07-23	Last Verified 2014-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: STA-9090 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.	DRUG: STA-9090 Given IV RADIATION: Radiologic imaging radiologic modalities used to evaluate response to treatment 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: STA-9090

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.

DRUG: STA-9090

Given IV

RADIATION: Radiologic imaging

radiologic modalities used to evaluate response to treatment

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 Outcome Measures	Measure Description	Time Frame
Disease Control Rate	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.	at 8 weeks from the start of therapy

Secondary Outcome Measures	Measure Description	Time Frame
Best Response	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.	On-treatment date, to date of disease progression (assessed up to 1 year)
Overall Survival	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)	study entry to date of death or last date known alive (assessed over 2.5 yrs)
Number of Patients With Each Worst Grade Toxicity	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	On study date to 30 days following final dose of study drug

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Microscopic confirmation of a diagnosis of metastatic adenocarcinoma (pathology may be from either the primary tumor or metastatic lesion) or poorly differentiated carcinoma of the pancreas s/p 1 or 2 prior chemotherapy regimens for metastatic disease (excluding neuroendocrine tumors, periampullary tumors and cystadenocarcinoma)
Patients who received adjuvant or neoadjuvant therapy will be eligible if they have progressed within 6 months of completing therapy and have not received a metastatic regimen or if they progressed > 6 months after completing therapy and have received 1-2 lines of therapy for metastatic disease
Measurable disease by RECIST criteria
ECOG PS 0 or 1
Life expectancy of at least 12 weeks
Absolute neutrophil count (ANC) >= 1,500/mm^3
Platelet count >= 100,000/mm^3
Creatinine =< 2.0 mg/dl
Total bilirubin =< 2.0 mg/dl
AST and ALT =< 2.5 x ULN in absence of liver metastasis; =< 5 x ULN in presence of liver metastasis
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of therapy
Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation
Ability to understand and the willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study-specific procedures

Primary brain tumors or active brain metastases; however, patients with a history of CNS metastases will be eligible if they have been treated and are stable for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for a minimum of 2 weeks prior to enrollment
History of stroke within 6 months of treatment or other significant neurological limitations
History of or current coronary artery disease, myocardial infarction, angina pectoris, angioplasty of coronary bypass surgery
History of or current uncontrolled dysrhythmias, or requirement for antiarrhythmic medications, or Grade 2 or greater left bundle branch block
New York Heart Association class II/III/IV congestive heart failure with a history of dyspnea, orthopnea or edema that required current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers or diuretics
Current or prior radiation therapy to the left hemithorax
Major surgery within 4 weeks prior to entering the study
Poor venous access for study drug administration or would require a peripheral or central indwelling catheter for study drug administration; study drug administration via indwelling catheters is prohibited at this time
Use of any investigational agents within 4 weeks prior to entering the study
History of severe allergic reactions to excipients (e.g., Polyethylene glycol 300 and Polysorbate 80), including severe hypersensitivity reactions defined as >= Grade 3 based on NCI CTCAE version 4.0
Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation or systemic steroids for treatment of autoimmune disease), however, patients may receive steroids for stable CNS metastases as described in exclusion criterion 1
Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study
Ventricular ejection fraction (Ef) =< 55%
Baseline QTc > 470 msec or previous history of QT prolongation while taking other medications
Patients who received more than two lines of prior therapy for metastatic disease, neoadjuvant or post-op adjuvant therapy is not considered one line of therapy as long as there was > 6 months of disease-free interval
Pregnant or breast-feeding females

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Dana Cardin, MD, Vanderbilt-Ingram Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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