Trial Outcomes & Findings for Celecoxib as Adjuvant Biologic Therapy in Patients With Head and Neck and Lung Cancer (NCT NCT00527982)

NCT ID: NCT00527982

Last Updated: 2012-12-06

Results Overview

Number of patients with histological response based on changes in bronchoscopies from baseline to 12 months.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: Baseline to 12 months
• Results posted on: 2012-12-06

Participant Flow

Recruitment Period: September 29, 2005 to December 18, 2007. Patients were recruited at UT MD Anderson Cancer Center.

One patient registered determined to be inevaluable. Trial termination due to poor accrual and study program redesign.

Participant milestones

Measure	Celecoxib Treatment Celecoxib 600 mg orally daily	No Treatment
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Celecoxib Treatment Celecoxib 600 mg orally daily	No Treatment
Overall Study Physician Decision	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Celecoxib Treatment n=1 Participants Celecoxib 600 mg orally daily	No Treatment	Total n=1 Participants Total of all reporting groups
Age Categorical <=18 years	0 years n=5 Participants	—	0 years n=5 Participants
Age Categorical Between 18 and 65 years	1 years n=5 Participants	—	1 years n=5 Participants
Age Categorical >=65 years	0 years n=5 Participants	—	0 years n=5 Participants
Gender Female	1 participants n=5 Participants	—	1 participants n=5 Participants
Gender Male	0 participants n=5 Participants	—	0 participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 months

Population: No analysis. One registered patient inevaluable for response, study terminated early.

Number of patients with histological response based on changes in bronchoscopies from baseline to 12 months.

Outcome measures

Outcome data not reported

Adverse Events

Celecoxib Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Waun K. Hong, MD/Professor

UT MD Anderson Cancer Center

Email: CR_Study_Registration@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place