Induction Docetaxel/Cisplatin/5-fluorouracil (TPF) as Selector for Chemo Radiation Therapy (RT) Versus Partial Laryngectomy in Advanced Laryngeal Cancer

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Treatment of patients with one cycle of induction chemotherapy to select for organ preservation of the larynx has been proven as a standard approach. When compared to historical controls. The investigators propose to study patients with a similar treatment strategy (i.e. one cycle of induction chemotherapy followed by two more chemotherapy cycles, in advanced nodal disease, followed by chemoradiation for those responding to the initial chemotherapy. Those who fail to respond or fail in radiation will directly undergo surgery. The novelty of the proposed study is that non responders and failures will be given the opportunity of larynx preserving supracricoid laryngectomy. The investigators will attempt to reduce toxicity from induction chemotherapy and improve potency with the use of docetaxel/cisplatin/5-fluorouracil (TPF) in place of the standard regimen of cisplatin and 5-fluorouracil (PF). Emerging data demonstrates that induction regimens containing triplets with platinum, 5-fluorouracil, and taxanes produce higher response rates and less overall toxicity when compared to induction strategies utilizing PF

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

Details

• Lead Sponsor: Rabin Medical Center
• Collaborator: Davidoff Cancer Center
• Treatments: Cisplatin; Docetaxel; Fluorouracil

Criteria

Inclusion Criteria:

• Patients must have pathologically confirmed previously untreated, resectable, squamous cell carcinoma of the larynx.

• 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 of chest and neck.(pet scan optional)

• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.

• Pre-treatment laboratory criteria:

• WBC > 3500/ul, granulocyte > 1500/ul.

• Platelet count > 100,000/ul.

• Calculated or measured creatinine clearance > 60 cc/min.

• AST and ALT < 2.5 X ULN

• Patients must give documented informed consent to participate in this study.

Exclusion Criteria:

• Prior head and neck malignancy or active non-head and neck malignancy. Except for cured non-melanoma skin cancer,

• Prior head and neck radiation.

• Documented evidence of distant metastases.

• Active infection.

• Pregnancy or lactation. Patients must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.

• Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment.

• Age < 18 years.

• Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible.

• Patients with Grade > 2 peripheral neuropathy.

• Any history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.

Criteria for supracricoid resection for chemo selection non responders

Inclusion Criteria :

• At least one functional arytenoids (physical and radiological examinations)

• Involvement of thyroid cartilage including extrathyroid cartilage extension.

Exclusion criteria:

• Subglottic extension anteriorly.

• Pre epiglottic extension.

• Subglottic extension laterally.

• Interarytenoid involvement.

• Two Arytenoids involved.

Criteria for supracricoid resection for Chemoradiation failure:

Inclusion Criteria:

• At least one functional arytenoid (physical and radiological examinations)

• Involvement of thyroid cartilage (with no radiological evidence for extra thyroid Extension).

Exclusion Criteria:

• Extrathyroid cartilage extension.

• Involvement preepiglottic space.

• Subglottic extension.

• Interarytenoid involvement.