Chemotherapy AND Bcl-xL Inhibitor (AT-101) For Organ Preservation In Adults With Advanced Laryngeal Cancer
Condition: Laryngeal Cancer
MeSH terms: Laryngeal Neoplasms
Intervention: AT-101; Docetaxel; Cisplatin; Carboplatin
Intervention description: Patients will receive AT-101 40 mg orally two times a day.; Docetaxel (Taxotere) 75 mg/m2; Cisplatin 100 mg/m2; Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
Intervention MeSH terms: Carboplatin; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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