Phase 2 N=21 Prevention

Pioglitazone Hydrochloride in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia

Head and Neck Cancer · Oral Leukoplakia

Bottom Line

View on ClinicalTrials.gov: NCT00099021 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2009

Primary outcome: Primary: Patients' Overall Response — 0; 15; 2; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: pioglitazone hydrochloride (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Patients' Overall Response	0; 15; 2; 4; 15	—
SECONDARY Patients' Clinical Response	3; 14; 4; 0; 17	—
SECONDARY Patients' Histological (Tissue) Response	1; 2; 14; 4; 3	—

Summary

This phase II trial studies how well pioglitazone hydrochloride works in preventing head and neck cancer in patients who have oral leukoplakia. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of pioglitazone hydrochloride may be effective in preventing head and neck cancer.

Eligibility Criteria

Criteria:

ECOG 0-2
Diagnosis of oral cavity or oropharyngeal leukoplakia meeting 1 of the following criteria:
Biopsy-proven hyperplasia in high-risk anatomic areas (e.g., floor of the mouth, mobile tongue, oropharynx, or in any erythroplakia lesion)
Mild, moderate, or severe dysplasia at any site of the oral cavity or oropharynx within the lesion
Measurable lesion that is clinically characterized by leukoplakia, erythroplakia, or erythroleukoplakia
Able to be assessed by bi-directional measurements
Life expectancy: More than 3 months
Hemoglobin >= lower limit of normal for males and post-menopausal females OR
Hemoglobin >= 11 g/dL for premenopausal females
WBC > 3,000/mm^3
Hepatic: Bilirubin 125,000/mm^3
Index lesion must be located in an anatomic site accessible by punch biopsy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00099021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.