PhII Study STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer
Condition: Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage IV Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: STA-9090; Radiologic imaging; blood draw
Intervention description: Given IV; radiologic modalities used to evaluate response to treatment; Venous blood will be drawn from those patients who give consent. Serum will be used to look for biomarkers predictive of response
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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