Single-center Investigator Initiated Pilot Study Investigating the Tumor Response of Squamous Cell Carcinoma Lesions in Patients Under Lapatinib Treatment

Squamous Cell Carcinoma Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01666431
• Other study ID #: SZ10ON03
• Status: Terminated
• Phase: Phase 2
• First received: August 8, 2012
• Last updated: December 2, 2014
• Start date: June 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2014
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

Drug:
• Lapatinib

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Dermatology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	84 days	No
Secondary	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	84 days	Yes
Secondary	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	84 days	No