Phase II Trial of Erlotinib, Prior to Surgery or Radiation in Patients With Squamous Cell Cancers (SCC) of the Skin

This study has been terminated.

(Lack of primary outcome efficacy.)

Sponsor:

Collaborator:

OSI Pharmaceuticals

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT01059305

First received: January 28, 2010

Last updated: February 16, 2017

Last verified: February 2017

History of Changes

Results First Received: February 16, 2017

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: No masking; Primary Purpose: Treatment
Condition:	Skin Cancer
Intervention:	Drug: Erlotinib

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Process: February 15, 2011 to September 11, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Erlotinib	150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).

Participant Flow: Overall Study

	Erlotinib
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Erlotinib	150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).

Baseline Measures

	Erlotinib
Overall Participants Analyzed [Units: Participants]	10

Age [Units: Years] Median (Full Range)	70 (58 to 81)

Sex: Female, Male [Units: Participants] Count of Participants
Female	1 10.0%
Male	9 90.0%

Region of Enrollment [Units: Participants]
United States	10

Outcome Measures

1. Primary:

Overall Response [ Time Frame: 4 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Bonnie Glisson, MD/Professor, Thoracic/Head & Neck Med Oncology
Organization: The University of Texas (UT) MD Anderson Cancer Center
phone: 713-792-7734
e-mail: CR_Study_Registration@mdanderson.org

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01059305 History of Changes
Other Study ID Numbers:	2009-0723 NCI-2011-00252 ( Registry Identifier: NCI CTRP )
Study First Received:	January 28, 2010
Results First Received:	February 16, 2017
Last Updated:	February 16, 2017

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