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

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer

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Trial Information

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

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

- 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

- 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

- History of stroke within 6 months of treatment or other significant neurological

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients with disease control

Outcome Description:

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.

Outcome Time Frame:

8 weeks from the start of therapy

Safety Issue:


Principal Investigator

Dana Cardin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Food and Drug Administration

Study ID:

VICC GI 1016



Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
The Jones ClinicGermantown, Tennessee  38138