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A Phase II Study of Dasatinib (NSC #732517, IND #73969) In Patients With Chemosensitive Relapsed Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase II Study of Dasatinib (NSC #732517, IND #73969) In Patients With Chemosensitive Relapsed Small Cell Lung Cancer



- Determine the efficacy of dasatinib in patients with relapsed small cell lung cancer.


- Determine the objective response rate (complete and partial response) in patients
treated with this drug.

- Determine the overall survival of patients treated with this drug.

- Determine the toxicity of this drug in these patients.

- Evaluate surrogate biologic markers (FAK, paxillin, and SRC phosphorylation) in
peripheral mononuclear cells (PBMC) and VEGF and PDGF beta in serum.

OUTLINE: Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every
21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at least every 3 months for 1
year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 56 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed small cell lung cancer (SCLC)

- Limited or extensive stage disease

- Progressive or recurrent disease after an initial response to first-line treatment
with a platinum-based chemotherapy with or without concurrent definitive radiotherapy
to the chest

- Chemotherapy must have been completed at least 90 days prior to documentation of

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan

- Lesions that are not considered measurable include the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural or pericardial effusion

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Tumor lesions situated in a previously irradiated area, unless progression
after radiotherapy is documented in these lesions

- No known brain metastases

- Previously treated brain metastases allowed provided they are neurologically
stable for ≥ 4 weeks


- ECOG performance status 0-1

- Platelet count ≥ 100,000/mm^3

- WBC ≥ 1,500/mm^3

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min

- AST ≤ 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 6 weeks after
completion of study therapy

- No significant cardiac disease, including any of the following:

- New York Heart Association class III-IV heart disease

- Myocardial infarction or ventricular tachyarrhythmia within the past 6 months

- Prolonged QTc > 480 msec (Fridericia correction)

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


- No more than 1 prior chemotherapy regimen

- No prior dasatinib or compounds of similar chemical composition or similar biologic
therapeutic activity including, but not limited to, any inhibitors of SRC, BCR-ABL,
c-KIT, EPHA2, or PDGFRβ kinases

- At least 2 weeks since prior definitive or palliative radiotherapy

- Prior radiotherapy allowed in the context of combined modality treatment with
curative intent for limited stage disease; prophylactic cranial radiotherapy; or
palliative radiotherapy initially or at relapse

- At least 2 weeks since prior surgery and recovered

- At least 1 week since prior and no concurrent agents with proarrhythmic potential

- At least 1 week since prior and no concurrent CYP3A4 inhibitors or inducers

- At least 1 week since prior and no concurrent grapefruit concentrate

- No concurrent palliative radiotherapy

- No concurrent hormones or other chemotherapeutic agents, except steroids for adrenal
failure, hormones for noncancer-related conditions (e.g., insulin for diabetes), or
intermittent dexamethasone as an antiemetic

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent chemotherapeutic or investigational agents

Type of Study:


Study Design:

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

Outcome Measure:

6 Week Progression Free Survival

Outcome Description:

Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method. Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions.

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Antonius Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center Hematology/Oncology Wake Forest University


United States: Food and Drug Administration

Study ID:




Start Date:

April 2007

Completion Date:

June 2010

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • limited stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



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