Pioglitazone in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer; Precancerous/Nonmalignant Condition
Intervention: pioglitazone hydrochloride (Drug); chemoprevention (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: University of Minnesota Official(s) and/or principal investigator(s):
Frank G. Ondrey, MD, PhD, Principal Investigator, Affiliation: University of Minnesota
Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of pioglitazone may be effective in preventing
head and neck cancer.
PURPOSE: This phase II trial is studying the effectiveness of pioglitazone in preventing head
and neck cancer in patients who have oral leukoplakia.
Clinical Details
Official title: A Phase IIA Cancer Prevention Trial of PPAR Gamma Agonist Pioglitazone in Oral Leukoplakia
Study design: Prevention, Open Label
Primary outcome: Effects on reversal of leukoplakia
Secondary outcome: Safety and tolerability
Detailed description:
OBJECTIVES:
Primary
- Determine whether pioglitazone reverses leukoplakia in patients with hyperplastic or
dysplastic oral cavity or oropharyngeal leukoplakia.
Secondary
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive oral pioglitazone once daily for 12 weeks in the absence of disease
progression, unacceptable toxicity, or the development of carcinoma.
Patients are followed at 4, 8, 12, and 16 weeks.
PROJECTED ACCRUAL: A total of 13-33 patients will be accrued for this study within 2 years.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- 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
- Index lesion must be located in an anatomic site accessible by punch biopsy
- Able to be assessed by bi-directional measurements
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- More than 3 months
Hematopoietic
- Hemoglobin ≥ lower limit of normal for males and post-menopausal females OR
- Hemoglobin ≥ 11 g/dL for premenopausal females
- WBC > 3,000/mm^3
- Platelet count > 125,000/mm^3
Hepatic
- Bilirubin < 1. 5 times upper limit of normal (ULN)
- AST and ALT < 1. 5 times ULN
Renal
- BUN < 1. 5 times ULN
- Creatinine < 1. 5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No contraindication to thiazolidinediones
- No allergy to pioglitazone or other thiazolidinediones
- No serious oral infection
- No invasive carcinoma within the past 60 months except nonmelanoma skin cancer or
carcinoma in situ of the cervix
- No concurrent malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 3 months since prior biologic or immunologic therapy
Chemotherapy
- Not specified
Endocrine therapy
- No concurrent insulin for diabetes
Radiotherapy
- No prior radiotherapy to the oral cavity
Surgery
- Not specified
Other
- More than 3 months since prior chemopreventative agents
- More than 3 months since prior experimental therapy
- More than 3 months since prior megadose vitamins or alternative therapy
- No prior thiazolidinediones
- No prior participation in this study
- No concurrent pharmacologic treatment for diabetes
- Concurrent chronic use of non-steroidal anti-inflammatory drugs allowed
Locations and Contacts
University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database Featured trial article
Starting date: June 2003
Last updated: December 25, 2007
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