Dasatinib in Treating Patients With Metastatic Pancreatic Cancer

Stage IV Pancreatic Cancer Clinical Trial

Official title:

Phase II Study of Dasatinib (BMS-354825) in Patients With Metastatic Adenocarcinoma of the Pancreas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474812
• Other study ID #: NCI-2009-00228
• Secondary ID: NCI-2009-00228CD
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2007
• Last updated: April 14, 2015
• Start date: May 2007
• Est. completion date: February 2014

Study information

• Verified date: November 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with metastatic pancreatic cancer.

Description:

PRIMARY OBJECTIVE:

I. Determine the overall survival, including median survival, of patients with metastatic adenocarcinoma of the pancreas treated with dasatinib.

SECONDARY OBJECTIVES:

I. Determine the effects of this drug on quantities of circulating tumor cells in these patients.

II. Determine the time to progression in patients treated with this drug. III. Determine pre- and post-drug fat-free mass and gait speed in patients treated with this drug.

IV. Evaluate the toxicity of this drug in these patients. V. Evaluate objective response rate in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection at baseline and during days 25-31. Samples are analyzed for quantification of circulating tumor cells. Patients also undergo analysis of fat-free mass and gait speed at baseline and at 1, 2, and 6 months.

After completion of study treatment, patients are followed periodically.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

• Metastatic disease

• Measurable or evaluable/nonmeasurable disease

• No known brain metastases

• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

• Life expectancy > 12 weeks

• Absolute granulocyte count >= 1,500/mm^3

• Platelet count >= 100,000/mm^3

• Hemoglobin > 8.5 g/dL

• Bilirubin =< 1.5 times upper limit of normal (ULN)

• AST and ALT =< 2.5 times ULN

• Creatinine =< 2.0 mg/dL

• Not pregnant or nursing

• No history of allergic reactions attributed to compounds of similar chemical or biological composition to dasatinib

• No QTc prolongation (i.e., QTc interval >= 480 msecs [Fridericia correction]) or other significant ECG abnormalities

• LVEF normal by MUGA scan

• No condition that impairs ability to swallow and retain dasatinib tablets, including any of the following:

• Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation

• Prior surgical procedures affecting absorption

• Active peptic ulcer disease

• No clinically significant cardiovascular disease, including any of the following:

• Myocardial infarction or ventricular tachyarrhythmia within the past 6 months

• Major conduction abnormality (unless a cardiac pacemaker is present)

• Recovered from all prior therapy

• More than 4 weeks since prior adjuvant chemotherapy (6 weeks for nitrosoureas or mitomycin C) and/or radiotherapy

• No prior chemotherapy for metastatic disease

• More than 4 weeks since prior EGFR inhibitors (e.g., imatinib mesylate, gefitinib, erlotinib hydrochloride, or lapatinib ditosylate)

• No prior EGFR inhibitors that target Src kinases

• At least 7 days since prior and no concurrent agents with proarrhythmic potential

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent grapefruit or grapefruit juice

• No other concurrent anticancer agents or therapies

• No concurrent systemic antacids (i.e., H2-receptor antagonists and proton pump inhibitors) [Locally acting antacids (e.g., Maalox, Mylanta) allowed within either 2 hours before or 2 hours after dasatinib therapy]

• No concurrent uncontrolled illness, including, but not limited to, any of the following:

• Ongoing or active infection

• History of significant bleeding disorder, including congenital (von Willebrand's disease) or acquired (anti-factor VIII antibodies) disorders

• Large pleural effusions

• Psychiatric illness or social situation that would preclude study compliance

• More than 7 days since prior and no concurrent CYP3A4 inducers or inhibitors

• No other concurrent investigational agents

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:
• dasatinib

Procedure:
• laboratory biomarker analysis
Correlative study
• physiologic testing
Correlative study

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Overall Survival	From the date of onset of treatment to the date of death and to the date of last follow-up for those still alive, assessed up to 24 months	assessed up to 24 months	No
Secondary	Objective Response Rate (Complete Response, Partial Response, or Stable Disease), Evaluated Using the New International Criteria Proposed by the RECIST Committee	Response is defined as CR (Complete Response), PR (Partial Response) or SD (Stable Disease) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. SD: neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease (PD). Progressive disease (PD) is defined as: at least a 20% increase in the sum of the LD of target lesions.	Up to 5 years	No
Secondary	Median Progression Free Survival (PFS)	Number of months patients were free of disease progression, defined as < 20% increase in the sum of the LD of target lesions nor the appearance of one or more new lesions.	Up to 5 years	No
Secondary	Gait Speed	Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.	baseline	No
Secondary	Gait Speed	Gait speed, determined by a 4 meter walk along a properly measured stretch of hallway while being timed with a stopwatch.	at 8 weeks	No