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

Stage IV Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01227018
• Other study ID #: VICC GI 1016
• Secondary ID: NCI-2010-02123
• Status: Terminated
• Phase: Phase 2
• First received: October 20, 2010
• Last updated: June 23, 2014
• Start date: December 2010
• Est. completion date: May 2013

Study information

• Verified date: June 2014
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	The Jones Clinic	Memphis	Tennessee
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarker Evaluation	Serum will be tested for biomarkers that may be predictive of response, optional per patient consent.	Pre-treatment and 1 week post-treatment	No
Primary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	Yes

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial