Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate a new treatment approach for adults with advanced laryngeal cancer: induction chemotherapy with platinum and docetaxel plus AT-101. AT-101 is an investigational drug for the treatment of advanced cancer. It is hoped that the combination of this chemotherapy regimen will allow cancer patients to keep their voice box and to improve/maintain voice-related quality of life. The ultimate goal of this study is to prevent the surgery to remove subjects voice box.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Treatments: Carboplatin; Cisplatin; Docetaxel; Gossypol; Gossypol acetic acid

Criteria

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 surgery and 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 for carboplatin candidates

• Adequate bilirubin, AST (aspartate aminotransferase), and ALT (alanine transaminase) function

Exclusion Criteria:

• Prior head and neck malignancy or history of other prior non-head and neck malignancy within 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 investigator would compromise the patient's ability to tolerate this treatment

• Patients residing in prison

• Patients with psychiatric/ social situations that would limit compliance with study requirements

• 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, or resection of the stomach or small bowel, ulcerative colitis, inflammatory bowel disease, 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