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
Overview
- Phase
- Phase 2
- Intervention
- dasatinib
- Conditions
- Recurrent Skin Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 7
- Locations
- 3
- Primary Endpoint
- Objective Response Rate (Complete Response and Partial Response)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This phase II trial is studying how well dasatinib works in treating patients with unresectable or metastatic squamous cell skin cancer or RAI Stage 0-I chronic lymphocytic leukemia. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of 1 of the following
- •Histologically or cytologically confirmed squamous cell carcinoma of the skin
- •Unresectable or metastatic disease
- •Squamous cell histology represents ≥ 50% of the biopsy specimen
- •May or may not be related to autologous or allogeneic organ transplantation
- •Chronic lymphocytic leukemia (CLL)
- •RAI stage 0-I
- •Stable disease
- •Patients with basalosquamous cell disease (basal cell with squamous differentiation) are eligible
- •Measurable disease, defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I (dasatinib 100 mg PO BID)
Patients receive 100 mg dasatinib PO BID on days 1-28
Intervention: dasatinib
Arm I (dasatinib 100 mg PO BID)
Patients receive 100 mg dasatinib PO BID on days 1-28
Intervention: laboratory biomarker analysis
Arm II (dasatinib 70 mg PO BID)
Patients receive 70 mg dasatinib PO BID on days 1-28
Intervention: dasatinib
Arm II (dasatinib 70 mg PO BID)
Patients receive 70 mg dasatinib PO BID on days 1-28
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- COX-2 Presence by IHC(At baseline)
- Progression-free Survival(Time from start of treatment to time of progression, assessed up to 12 weeks)
- Presence of Total EphA2 and Both Total and Active Src and FAK by Immunohistochemistry (IHC)(At baseline)