Imatinib Mesylate (Gleevec) and Docetaxel in Patients With Head and Neck Squamous Cell Cancer

This study has been completed.

Study NCT00485485 Information provided by M.D. Anderson Cancer Center

First Received on June 12, 2007. Last Updated on July 28, 2011 History of Changes

Results First Received: July 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Head and Neck Cancer Squamous Cell Cancer
Interventions:	Drug: Imatinib Mesylate Drug: Docetaxel

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Overall Study Recruitment: 1/18/2007 - 3/18/2008. All recruitment done at UT MD Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patient has received any other investigational agents within 30 days of first day of study drug dosing; Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry, unless the disease is rapidly progressing.

Reporting Groups

	Description
Imatinib Mesylate + Docetaxel	Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks

Participant Flow: Overall Study

	Imatinib Mesylate + Docetaxel
STARTED	7
COMPLETED	7
NOT COMPLETED	0

Baseline Characteristics

Reporting Groups

	Description
Imatinib Mesylate + Docetaxel	Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks

Baseline Measures

	Imatinib Mesylate + Docetaxel
Number of Participants [units: participants]	7
Age [units: participants]
<=18 years	0
Between 18 and 65 years	6
>=65 years	1
Age [units: years] Mean ± Standard Deviation	62 ± 1
Gender [units: participants]
Female	2
Male	5
Region of Enrollment [units: participants]
United States	7

Outcome Measures

1. Primary:

Participant Response Rate [ Time Frame: At 6 weeks reconfirmed 6 weeks later ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

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

Limitations and Caveats

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
Study was closed to enrollment early due to low enrollment. Study enrolled 7 participants over approximately 2 years with a planned enrollment of up to 58.

Results Point of Contact:

Name/Title: Anne Tsao, M.D. / Associate Professor
Organization: UT MD Anderson Cancer Center
phone: 713-792-6363
e-mail: mejprice@mdanderson.org

No publications provided

Responsible Party:	Anne S. Tsao, MD/Assistant Professor, U.T.M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00485485 History of Changes
Other Study ID Numbers:	2006-0362
Study First Received:	June 12, 2007
Results First Received:	July 28, 2011
Last Updated:	July 28, 2011
Health Authority:	United States: Institutional Review Board