Dasatinib in Advanced Squamous Cell Lung Cancer



Status:Recruiting
Conditions:Lung Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:September 2011
Contact:Bruce Johnson, MD
Email:bruce_johnson@dfci.harvard.edu
Phone:617-632-3468

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Phase II Trial of Dasatinib in Advanced (Stage IIIB/IV) Squamous Cell Lung Cancer


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.

In this research study, the investigators are looking at how well dasatinib works in
treating squamous cell lung cancer.


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.

Inclusion Criteria:

- Stage III/B or IV squamous NSCLC

- Measurable disease

- Previously offered all standard chemotherapy regimens for advanced squamous cell lung
cancer

- 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 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

- Evidence of symptomatic pleural effusions unless undergoing a therapeutic
thoracentesis as part of non-study care

- 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
We found this trial at
3
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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