A Phase 2 Study of Dasatinib in Patients With Transplant and Non-Transplant Related Unresectable or Metastatic Cutaneous Squamous Cell Carcinoma and RAI Stage 0-1 Chronic Lymphocytic Leukemia
I. Determine the objective response rate (complete response and partial response) in
patients with unresectable or metastatic squamous cell carcinoma of the skin or RAI stage
0-I chronic lymphocytic leukemia receiving dasatinib.
I. Determine the progression-free survival of patients receiving this drug. II. Evaluate
tumor for presence of total EphA2 and both total and active Src and FAK by
immunohistochemistry (IHC) pre-treatment with dasatinib.
III. Evaluate tumor for presence of cyclooxygenase-2 by IHC pre-treatment with dasatinib.
OUTLINE: This is a multicenter study. Patients are stratified according to squamous cell
carcinoma of the skin origin (transplantation vs nontransplantation).
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
Pre-therapy tumor biopsy specimens are collected to detect total and phosphorylated Src and
FAK, total EphA2, and cyclooxygenase-2 by immunohistochemistry.
After completion of study treatment, patients are followed up monthly for up to 12 weeks.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate (complete response and partial response)
Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. The evaluation of response will be measured in subjects with CLL by using CT scans, just as in Standard of Care. Should patients demonstrate response to dasatinib, we will perform inferential comparisons using usual statistical methods.
Every 2 courses during treatment, assessed up to 12 weeks after completion of treatment
Ohio State University
United States: Food and Drug Administration
|Cincinnati Children's Hospital Medical Center||Cincinnati, Ohio 45229-3039|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|Ohio State University Medical Center||Columbus, Ohio 43210|
|M D Anderson Cancer Center||Houston, Texas 77030|