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

NCT01227018 | Terminated Phase 2 Results DMC

• 2 other identifiers: VICC GI 1016NCI-2010-02123
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Best Response

  On-treatment date, to date of disease progression (assessed up to 1 year)

• Overall Survival

  study entry to date of death or last date known alive (assessed over 2.5 yrs)

• Number of Patients With Each Worst Grade Toxicity

  On study date to 30 days following final dose of study drug

Other Outcomes (1)

• Biomarker Evaluation

  Pre-treatment and 1 week post-treatment

Study Arms (1)

STA-9090

EXPERIMENTAL

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; Radiation: Radiologic imaging; Procedure: blood draw

Interventions

STA-9090 DRUG

Given IV

STA-9090

Radiologic imaging RADIATION

radiologic modalities used to evaluate response to treatment

Also known as: computerized tomographic (CT) scan, magnetic resonance imaging (MRI), chest x-ray

STA-9090

blood draw PROCEDURE

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

STA-9090

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

The Jones Clinic

Memphis, Tennessee, 38138, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

STA 9090; Phantoms, Imaging; Magnetic Resonance Spectroscopy; X-Rays; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Dana Cardin
• Organization: Vanderbilt-Ingram Cancer Center

dana.cardin@vanderbilt.edu

615-936-8580

Study Officials

• Dana Cardin, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine; Medical Oncologist

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 22, 2010
• Study Start: December 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 23, 2014
• Results First Posted: July 23, 2014

Record last verified: 2014-06

Locations

US (2)