Dasatinib in Treating Patients With Unresectable or Metastatic Squamous Cell Skin Cancer or RAI Stage 0-I Chronic Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00563290|
Recruitment Status : Completed
First Posted : November 26, 2007
Results First Posted : March 20, 2015
Last Update Posted : June 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Skin Cancer Squamous Cell Carcinoma of the Skin Stage 0 Chronic Lymphocytic Leukemia Stage I Chronic Lymphocytic Leukemia||Drug: dasatinib Other: laboratory biomarker analysis||Phase 2|
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: Patients are assigned to 1 of 2 treatment arms.
ARM I: Patients receive 100 mg dasatinib orally (PO) twice daily (BID) on days 1-28.
ARM II (PATIENTS ENROLLED AFTER 11/18/08): Patients receive 70 mg dasatinib PO BID on days 1-28.
In both arms, 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||October 2014|
Experimental: Arm I (dasatinib 100 mg PO BID)
Patients receive 100 mg dasatinib PO BID on days 1-28
Other: laboratory biomarker analysis
Experimental: Arm II (dasatinib 70 mg PO BID)
Patients receive 70 mg dasatinib PO BID on days 1-28
Other: laboratory biomarker analysis
- Objective Response Rate (Complete Response and Partial Response) [ Time Frame: Every 2 courses during treatment, assessed up to 12 weeks after completion of treatment ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Progression-free Survival [ Time Frame: Time from start of treatment to time of progression, assessed up to 12 weeks ]Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Presence of Total EphA2 and Both Total and Active Src and FAK by Immunohistochemistry (IHC) [ Time Frame: At baseline ]Performed per standard protocols by the Pathology Department.
- COX-2 Presence by IHC [ Time Frame: At baseline ]Performed per standard protocols by the Pathology Department. Samples will be obtained pre-therapy. Determination of the COX-2 tumor status on this trial will develop the beginnings of a data base upon which future therapy may be designed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563290
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Thomas Olencki||Ohio State University|