Lung Cancer Clinical Trial
Dasatinib in Advanced Squamous Cell Lung Cancer
Summary
Dasatinib is a drug that has been shown to stop some cancer cells from growing. This drug has been used in treatment for other types of cancer and information from other research studies suggests that dasatinib may help to stop squamous cell lung cancer from growing, especially in individuals whose tumor has a mutation in the DDR2 gene.
Advanced squamous cell lung cancer (SqCC) carries a poor prognosis and new therapeutic targets are needed. Several studies have examined dasatinib in NSCLC; these report significant toxicities, but also responses in patients found to harbor mutations in DDR2 or BRAF.
An open-label phase II trial with dasatinib was carried out to determine the response rates in patients with SqCC who had previously failed standard chemotherapy and to correlate responses with patient genotype.
Full Description
Dasatinib will be taken orally, daily in cycles of 28 days.
On the first day of study treatment and at 2 weeks, 4 weeks and then every 4 weeks subjects will have the following:
Medical history and clinical exam
Safety blood tests
Measurement of Performance Status
Review of pill log
CT scans will be done every 8 weeks.
In this research study, the investigators are looking at how well dasatinib works in treating squamous cell lung cancer.
Dasatinib administered at 140mg per day for the treatment of advanced SqCC of the lung is associated with excess adverse events, similar to other studies, so is not recommended in unselected patients. Further work to identify patients likely to benefit from dasatinib and in managing dasatinib-related toxicities is needed.
Eligibility Criteria
Inclusion Criteria:
Stage III/B or IV squamous NSCLC
Measurable disease
Previously offered all standard chemotherapy regimens for advanced squamous cell lung cancer
ECOG performance status of 0 or 1
Estimated life expectancy greater than 12 weeks
Normal organ and marrow function
Confirmed availability of archival pathology samples
Agrees to discontinue St. Johns Wort
Able to take medications by mouth
Willing and able to use acceptable method of birth control for the entire study period and for at least 4 weeks after the last dose of study drug
Exclusion Criteria:
Pregnant or breast-feeding
Chemotherapy or radiotherapy within 4 weeks prior to entering study
Receiving any other investigational agents
Known untreated or progressive brain metastases
History of prior treatment with or allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib, nilotinib or imatinib
Taking medications known to be potent CYP3A4 inhibitors
Currently taking H2 inhibitors or proton pump inhibitors
Currently taking drugs or have taken drugs in the past 7 days that are generally accepted to have a risk of causing Torsades de Pointes
HIV positive
Clinically uncontrolled hypertension (blood pressure > 160/110)
Previous or concurrent malignancy except adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 5 years
Active and uncontrolled clinically significant infection
Chronic gastrointestinal disease
Acquired or congenital bleeding disorder or clinically significant gastrointestinal bleeding within 3 months
Supplemental oxygen required for current malignancy
Evidence of symptomatic pleural effusions unless undergoing a therapeutic thoracentesis as part of non-study care
Individuals who are prisoners or who are compulsory detained for medical or psychiatric reasons
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration
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There are 2 Locations for this study
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
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