Celecoxib as Adjuvant Biologic Therapy in Patients With Head and Neck and Lung Cancer

This study has been terminated.

( Termination due to poor accrual. )

Study NCT00527982 Information provided by M.D. Anderson Cancer Center

First Received on September 10, 2007. Last Updated on June 10, 2011 History of Changes

Results First Received: January 6, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Head and Neck Cancer Lung Cancer
Intervention:	Drug: Celecoxib

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: September 29, 2005 to December 18, 2007. Patients were recruited 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
One patient registered determined to be inevaluable. Trial termination due to poor accrual and study program redesign.

Reporting Groups

	Description
Celecoxib Treatment	600 mg orally daily
No Treatment	No text entered.

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Celecoxib Treatment	600 mg orally daily
No Treatment	No text entered.

Baseline Measures

	Celecoxib Treatment	No Treatment	Total
Number of Participants [units: participants]	1	0	1
Age [units: years]
<=18 years	0	0	0
Between 18 and 65 years	1	0	1
>=65 years	0	0	0
Gender [units: participants]
Female	1	0	1
Male	0	0	0
Region of Enrollment [units: participants]
United States	1	0	1

Outcome Measures

1. Primary:

Histological Responses [ Time Frame: Baseline to 12 months ]

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
No text entered.

Results Point of Contact:

Name/Title: Waun K. Hong, MD/Professor
Organization: UT MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org

No publications provided

Responsible Party:	Waun K. Hong, MD/Professor, U.T.M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00527982 History of Changes
Other Study ID Numbers:	2004-0104
Study First Received:	September 10, 2007
Results First Received:	January 6, 2011
Last Updated:	June 10, 2011
Health Authority:	United States: Institutional Review Board