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Recurrent Skin CancerPhase 2NCT00563290

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

A Phase 2 study testing dasatinib and laboratory biomarker analysis in people with Recurrent Skin Cancer and Squamous Cell Carcinoma of the Skin, run by National Cancer Institute (NCI) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
dasatinib and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
3 sitesUnited States
Study dates
Nov 2007to Oct 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 65Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
dasatinib, laboratory biomarker analysis
Medical subject headings
Skin Neoplasms, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dasatinibDrug

    Also called BMS-354825, Sprycel

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00563290
Study groupRoleWhat they receive
Arm I (dasatinib 100 mg PO BID)ExperimentalPatients receive 100 mg dasatinib PO BID on days 1-28
Receives: Drug: dasatinib; Other: laboratory biomarker analysis
Arm II (dasatinib 70 mg PO BID)ExperimentalPatients receive 70 mg dasatinib PO BID on days 1-28
Receives: Drug: dasatinib; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (Complete Response and Partial Response)

    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.

    Measured: Every 2 courses during treatment, assessed up to 12 weeks after completion of treatment

Secondary outcomes (3)

  1. Progression-free Survival

    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

    Measured: Time from start of treatment to time of progression, assessed up to 12 weeks

  2. Presence of Total EphA2 and Both Total and Active Src and FAK by Immunohistochemistry (IHC)

    Performed per standard protocols by the Pathology Department.

    Measured: At baseline

  3. COX-2 Presence by IHC

    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.

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionApr 2012
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00563290
Sponsor's protocol ID
NCI-2009-00226
Other IDs
NCI-2009-00226, CDR0000576527, OSU-07070, OSU 07070, 7813, P30CA016058, N01CM00070
Status last verified
Mar 2015
First submitted
22 Nov 2007
Last updated
18 Jun 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dasatinib and laboratory biomarker analysis in people with Recurrent Skin Cancer and Squamous Cell Carcinoma of the Skin, run by National Cancer Institute (NCI) at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 65 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00563290.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2015.

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