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

Phase 2

Terminated

• Conditions: Squamous Cell Carcinoma
• Interventions: Drug: Lapatinib

• Registration Number: NCT01666431
• Lead Sponsor: University of Zurich

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-16
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lapatinib	Lapatinib	-

Primary Outcome Measures

Name	Time	Method
Macroscopic evaluation of tumour response	84 days	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

Name	Time	Method
Evaluation of tolerability	84 days	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	84 days	Investigation of molecular tumour response of squamous cell carcinoma lesions in patients under lapatinib treatment using a set of variables

Trial Locations

Locations (1)

University Hospital Zurich, Division of Dermatology; 🇨🇭 Zurich, ZH, Switzerland