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Trial record 1 of 3 for:    HSP90 | "Pancreatic Neoplasms"
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PhII Study STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01227018
Recruitment Status : Terminated (interim analysis found the study drug to be ineffective)
First Posted : October 22, 2010
Results First Posted : July 23, 2014
Last Update Posted : July 23, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dana Cardin, MD, Vanderbilt-Ingram Cancer Center

Tracking Information
First Submitted Date  ICMJE October 20, 2010
First Posted Date  ICMJE October 22, 2010
Results First Submitted Date  ICMJE June 23, 2014
Results First Posted Date  ICMJE July 23, 2014
Last Update Posted Date July 23, 2014
Study Start Date  ICMJE December 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
Disease Control Rate [ Time Frame: at 8 weeks from the start of therapy ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2010)
Disease control rate (CR + PR + SD) [ Time Frame: 8 weeks from the start of therapy ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
  • Best Response [ Time Frame: On-treatment date, to date of disease progression (assessed up to 1 year) ]
    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) ]
    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 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2010)
  • Rate of response as measured by RECIST criteria [ Time Frame: Periodically during study treatment ]
  • Overall survival [ Time Frame: After completion of study treatment ]
  • Safety and toxicity assessments for this patient population [ Time Frame: After completion of study treatment ]
Current Other Pre-specified Outcome Measures
 (submitted: June 23, 2014)
Biomarker Evaluation [ Time Frame: Pre-treatment and 1 week post-treatment ]
Serum will be tested for biomarkers that may be predictive of response, optional per patient consent.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PhII Study STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer
Official Title  ICMJE Phase II Study of STA-9090 as Second or Third-Line Therapy for Metastatic Pancreas Cancer
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage IV Pancreatic Cancer
Intervention  ICMJE
  • Drug: STA-9090
    Given IV
  • Radiation: Radiologic imaging
    radiologic modalities used to evaluate response to treatment
    Other Names:
    • computerized tomographic (CT) scan
    • magnetic resonance imaging (MRI)
    • chest x-ray
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: STA-9090
  • Radiation: Radiologic imaging
  • Procedure: blood draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 19, 2013)
15
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2010)
43
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01227018
Other Study ID Numbers  ICMJE VICC GI 1016
NCI-2010-02123
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dana Cardin, MD, Vanderbilt-Ingram Cancer Center
Study Sponsor  ICMJE Vanderbilt-Ingram Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Dana Cardin, MD Vanderbilt-Ingram Cancer Center
PRS Account Vanderbilt-Ingram Cancer Center
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP