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Dasatinib in Treating Patients With Unresectable or Metastatic Squamous Cell Skin Cancer or RAI Stage 0-I Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00563290
First received: November 22, 2007
Last updated: March 18, 2013
Last verified: March 2013

November 22, 2007
March 18, 2013
November 2007
February 2011   (final data collection date for primary outcome measure)
Objective response rate (complete response and partial response) [ Time Frame: Every 2 courses during treatment, assessed up to 12 weeks after completion of treatment ] [ Designated as safety issue: No ]
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.
Objective response rate (complete response+partial response)
Complete list of historical versions of study NCT00563290 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: Time from start of treatment to time of progression, assessed up to 12 weeks ] [ Designated as safety issue: No ]
    Progression will be evaluated in this study using the new international criteria proposed by the RECIST Committee. Analysis will be preliminary to provide and estimate of variability of endpoints in the patient population for which previous data are not available
  • Presence of total EphA2 and both total and active Src and FAK by immunohistochemistry (IHC) [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Performed per standard protocols by the Pathology Department.
  • COX-2 presence by IHC [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    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.
  • Progression-free survival
  • Total EphA2 and both total and active Src and FAK by immunohistochemistry (IHC)
  • COX-2 presence by IHC
Not Provided
Not Provided
 
Dasatinib in Treating Patients With Unresectable or Metastatic Squamous Cell Skin Cancer or RAI Stage 0-I Chronic Lymphocytic Leukemia
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

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

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: 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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Skin Cancer
  • Squamous Cell Carcinoma of the Skin
  • Stage 0 Chronic Lymphocytic Leukemia
  • Stage I Chronic Lymphocytic Leukemia
  • Drug: dasatinib
    Other Names:
    • BMS-354825
    • Sprycel
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Treatment (kinase inhibitor therapy)
Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: dasatinib
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35
Not Provided
February 2011   (final data collection date for primary outcome measure)

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
  • Must be willing to undergo a pre-treatment tumor biopsy
  • Brain metastases are allowed provided the following are true:

    • Received definitive therapy consisting of external beam radiation therapy, gamma knife therapy, or surgical resection resulting in clinically stable disease
    • Lesions are under control for at least 4 weeks after completion of definitive therapy, as measured by repeat MRI or CT scans
    • No requirement for dexamethasone
  • ECOG performance status 0-1 OR Karnofsky 60-100%
  • Life expectancy > 6 months
  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelets ≥ 100,000/mm^3
  • Total bilirubin ≤ 1.5 times upper limit of normal(ULN)
  • AST/ALT ≤ 2.5 times ULN
  • Potassium 3.5 - 5.1 mmol/L
  • Calcium > lower limit of normal
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • No known HIV 1 or HIV 2 positivity
  • No known hepatitis C or hepatitis B positivity
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to dasatinib
  • No QTc prolongation, defined as a QTc interval of ≥ 480 msecs or other significant ECG abnormality
  • No condition that impairs the ability to swallow and retain dasatinib tablets (e.g., gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, prior surgical procedure affecting absorption, or active peptic ulcer disease)
  • No clinically significant cardiovascular disease including the following:

    • Myocardial infarction within 6 months
    • Uncontrolled angina within 3 months
    • Diagnosed or suspected congenital long QT syndrome
    • Any history of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsades de Pointe)
    • Any history of second or third degree heart block (may be eligible if the subject currently has a pacemaker)
    • Heart rate consistently < 50 beats/minute on pre-entry ECG
    • Uncontrolled hypertension
    • Ejection fraction < 45% by transthoracic echo
  • No uncontrolled intercurrent illness including, but not limited to, the following:

    • Ongoing or active infection requiring intravenous antibiotics
    • History of significant bleeding disorder, including congenital (von Willebrand's disease) or acquired (anti-factor VIII antibodies) disorders
    • Psychiatric illness or social situations that would limit compliance with study requirements
  • No prior malignancy except for adequately treated basal cell cancer, carcinoma in situ of the cervix, or other cancer for which the patient has been disease free for 3 years
  • No gastro-esophageal reflux disease dependent on proton pump inhibitors, H2 blockers, or antacids
  • Recovered from prior therapy
  • No more than 1 prior therapy with a monoclonal antibody
  • No more than 1 prior chemotherapy regimen
  • No prior tyrosine kinase inhibitor therapy

    • Prior erlotinib hydrochloride allowed
  • More than 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
  • At least 4 weeks since prior radiotherapy

    • Measurable disease must be outside the radiotherapy port
  • At least 2 weeks since prior topical therapy
  • At least 4 weeks since prior surgery requiring general anesthesia and intubation
  • At least 120 days (4 months) since prior amiodarone
  • At least 7 days since prior and no concurrent anti-thrombotic and/or platelet agents (e.g., warfarin, heparin, low molecular weight heparin, aspirin [full dose and 81 mg dose] and/or ibuprofen)
  • At least 7 days since prior and no concurrent agents with pro-arrhythmic potential
  • More than 7 days or 5 half lives, whichever is greater, since prior and no concurrent agents or substances that induce or inhibit CYP3A4
  • No concurrent bisphosphonate therapy for the first 8 weeks of dasatinib treatment
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00563290
NCI-2009-00226, OSU 07070, N01CM00070
No
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Thomas Olencki Ohio State University
National Cancer Institute (NCI)
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP