Back to resultsSingle-center Investigator Initiated Pilot Study Investigating the Tumor Response of Squamous Cell Carcinoma Lesions in Patients Under Lapatinib Treatment
Primary Purpose
Squamous Cell Carcinoma
Status
Terminated
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Lapatinib
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma
Eligibility Criteria
Inclusion criteria:
- Age ≥ 18 years
- Diagnosis of histologically confirmed cutaneous SCC stage Tis-T2N0 for which surgical treatment is considered suitable.
- In case of SCC, patients must present with a minimum of two co-existing AK lesions. In case of Keratoacanthoma, one lesion of sufficient size (=1cm) is acceptable.
- All included patients must have both FFPE and frozen material available.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ system function
Exclusion criteria:
- Subjects who have current active hepatic or biliary disease
- Other non-controlled malignancy
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study treatment.
- Presence of uncontrolled infection
- History of any one or more of the following cardiovascular conditions within the past 6 months:Cardiac angioplasty or stenting;Myocardial infarction;Unstable angina;Coronary artery bypass graft surgery;Symptomatic peripheral vascular disease; Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
- Poorly controlled hypertension
- History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- Prior exposure to the study drug lapatinib
- Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer
Sites / Locations
- University Hospital Zurich, Division of Dermatology
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lapatinib
Arm Description
Outcomes
Primary Outcome Measures
Macroscopic evaluation of tumour response
The primary efficacy objective is to evaluate the tumour response macroscopically in patients with primary cutaneous SCC lesions and in concomitant SCC in situ (AK) by documenting changes in quantity and two-dimensional measurements (mm).
Secondary Outcome Measures
Evaluation of tolerability
Evaluation of tolerability of a single dose regimen of systemic lapatinib therapy in patients with SCC as measured by time to first AE or SAE within the study period
Molecular evaluation of tumour response
Investigation of molecular tumour response of squamous cell carcinoma lesions in patients under lapatinib treatment using a set of variables
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01666431
Brief Title
Single-center Investigator Initiated Pilot Study Investigating the Tumor Response of Squamous Cell Carcinoma Lesions in Patients Under Lapatinib Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
5. Study Description
Brief Summary
Primary cutaneous squamous cell carcinomas (SCCs) are epithelial carcinomas with a high frequency of EGF-R expression. EGFR is an important regulator of tumour progression and proliferation in several types of cancer. Mechanism of action of Lapatinib in the EGFR and/or HER2 expressing oesophageal squamous cell carcinoma (ESCC) cells is attributed to inhibition of cell proliferation and induction of apoptosis. Based on the data from oesophageal SCCs the investigators hypothesise that EGFR signalling pathway and its interactions play an important role in the SCC pathogenesis and represent a good therapeutic target from these tumours.
Primary Objectives:
To evaluate the tumour response macroscopically in patients with primary cutaneous SCC lesions and in concomitant SCC in situ (AK).
Secondary Objectives:
To evaluate tolerability of a single dose regimen of systemic lapatinib therapy in patients with SCC as measured by time to first AE or SAE within the study period.
To investigate the molecular tumour response of squamous cell carcinoma lesions in patients under lapatinib treatment using a set of variables.
Trial with medicinal product
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lapatinib
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Lapatinib
Primary Outcome Measure Information:
Title
Macroscopic evaluation of tumour response
Description
The primary efficacy objective is to evaluate the tumour response macroscopically in patients with primary cutaneous SCC lesions and in concomitant SCC in situ (AK) by documenting changes in quantity and two-dimensional measurements (mm).
Time Frame
84 days
Secondary Outcome Measure Information:
Title
Evaluation of tolerability
Description
Evaluation of tolerability of a single dose regimen of systemic lapatinib therapy in patients with SCC as measured by time to first AE or SAE within the study period
Time Frame
84 days
Title
Molecular evaluation of tumour response
Description
Investigation of molecular tumour response of squamous cell carcinoma lesions in patients under lapatinib treatment using a set of variables
Time Frame
84 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Age ≥ 18 years
Diagnosis of histologically confirmed cutaneous SCC stage Tis-T2N0 for which surgical treatment is considered suitable.
In case of SCC, patients must present with a minimum of two co-existing AK lesions. In case of Keratoacanthoma, one lesion of sufficient size (=1cm) is acceptable.
All included patients must have both FFPE and frozen material available.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ system function
Exclusion criteria:
Subjects who have current active hepatic or biliary disease
Other non-controlled malignancy
Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study treatment.
Presence of uncontrolled infection
History of any one or more of the following cardiovascular conditions within the past 6 months:Cardiac angioplasty or stenting;Myocardial infarction;Unstable angina;Coronary artery bypass graft surgery;Symptomatic peripheral vascular disease; Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
Poorly controlled hypertension
History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
Prior exposure to the study drug lapatinib
Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinhard Dummer, Professor MD
Organizational Affiliation
University Hospital Zurich, Division of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Dermatology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Single-center Investigator Initiated Pilot Study Investigating the Tumor Response of Squamous Cell Carcinoma Lesions in Patients Under Lapatinib Treatment
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