Last updated: July 18, 2023
Sponsor: University of Michigan Rogel Cancer Center
Overall Status: Completed
Phase
2
Condition
Head And Neck Cancer
Oral Cancer
Treatment
Cisplatin
Docetaxel
AT-101
Clinical Study ID
NCT01633541
UMCC 2010.101
HUM00043975
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients must have pathologically confirmed, previously untreated, resectable,squamous cell carcinoma of the larynx or hypopharynx.
- Disease must be Stage III or IV
- Tumor must be potentially surgically resectable and curable with conventional surgeryand radiation therapy
- Patients must undergo pre-treatment endoscopic tumor staging and CT scanning
- ECOG Performance status 0-1
- Adequate WBC (white blood cell), granulocyte and platelet counts
- Creatinine clearance of ≥ 60cc/min for cisplatin candidates and ≥ 30 cc/min forcarboplatin candidates
- Adequate bilirubin, AST (aspartate aminotransferase), and ALT (alanine transaminase)function
Exclusion
Exclusion Criteria:
- Prior head and neck malignancy or history of other prior non-head and neck malignancywithin the past 3 years
- Prior head and neck radiation or prior chemotherapy.
- Documented evidence of distant metastases
- Active infection
- Pregnancy or lactation
- Any medical or psychiatric illness which in the opinion of the principal investigatorwould compromise the patient's ability to tolerate this treatment
- Patients residing in prison
- Patients with psychiatric/ social situations that would limit compliance with studyrequirements
- Patients with Grade > 2 peripheral neuropathy
- History of severe hypersensitivity reaction to docetaxel
- Class 3 or 4 cardiac disease
- Unstable angina or history of myocardial ischemia within prior 6 months
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, orresection of the stomach or small bowel, ulcerative colitis, inflammatory boweldisease, partial or complete small bowel obstruction
- Prior use of gossypol or AT-101, or known hypersensitivity to gossypol or AT-101
- Patients taking any other concurrent approved or investigational anti-cancer therapy
Study Design
Total Participants: 55
Treatment Group(s): 4
Primary Treatment: Cisplatin
Phase: 2
Study Start date:
March 01, 2012
Estimated Completion Date:
November 06, 2021
Study Description
Connect with a study center
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
United StatesSite Not Available
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