ACTOplus Met XR in Treating Patients With Stage I-IV Oral Cavity or Oropharynx Cancer Undergoing Definitive Treatment
NCT02917629 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2023-03-08
Summary
This randomized phase IIb trial studies how well ACTOplus met extended release (XR) works in treating in patients with stage I-IV oral cavity or oropharynx cancer that are undergoing definitive treatment. Chemoprevention is the use of drugs to keep oral cavity or oropharynx cancer from forming or coming back. The use of ACTOplus met XR may slow disease progression in patients with oral cavity or oropharynx cancer.
Conditions
- Oral Cavity Neoplasm
- Oropharyngeal Neoplasm
- Stage 0 Oral Cavity Squamous Cell Carcinoma American Joint Committee on Cancer (AJCC) v6 and v7
- Stage 0 Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7
- Stage I Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage I Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7
- Stage II Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage II Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7
- Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
Interventions
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Metformide Hydrochloride/Pioglitazone Hydrochloride Extended-Release Tablet
Given PO
- OTHER
-
Pharmacological Study
Correlative studies
- OTHER
-
Placebo
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Frank G Ondrey · University of Wisconsin, Madison
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-31
- Primary Completion
- 2019-08-28
- Completion
- 2019-08-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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