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

Sponsor
University of Zurich
Study ID
NCT01666431
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib — DRUG

Study Details

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

Key Dates

Start date
Jun 30, 2012
Status verified
Dec 2014
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Lapatinib

Primary Outcome Measure

Macroscopic evaluation of tumour response [ Time Frame: 84 days ]

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