Phase 2
Completed N=21
Pioglitazone Hydrochloride in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia
Source: ClinicalTrials.gov NCT00099021 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcomePrimary: Patients' Overall Response — 0; 15; 2; 4 Participants
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.
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 | — |
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
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. Informational only — not medical advice.