A Pilot Study of Induction Chemotherapy Followed by Surgery for Locally Advanced Resectable Head and Neck Cancer

Stopped early · Early Phase 1

Conditions studied: Head and Neck Cancer

In brief

This is a non-randomized open-label investigator initiated pilot study comparing follow-up therapy of advanced head and neck cancer subjects initially treated with triple induction chemotherapy. Subjects will receive surgical treatment or combined chemoradiation therapy based on the subject's apparent clinical response. Spared use of radiation therapy for selective patients who have a complete response to induction chemotherapy could improve well being of this patient population without compromising survival.

Key facts

Study ID

NCT01111942

Run by

Southern Illinois University

People needed

4

Starts

2010-02-01

Expected to finish

2014-01-01

Last updated by the study team

2015-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to understand and the willingness to sign a written informed consent document.
• Histologically confirmed Stage III-IV (T1, T2, T3) (N0-N2) squamous cell carcinoma of the oropharynx staged according to AJCC guidelines.
• The subject must be considered surgically resectable via a transoral approach at the time of presentation.
• Age >18 years
• Life expectancy >/= 5 years
• ECOG performance status <2
• Subject must have measurable disease, at least one lesion accurately measured in at least one dimension as >10 mm with CT scan.
• Hematologic Absolute neutrophil count > 1,000/mm3, Hemoglobin > 8.0 g/dl Platelet count > 100,000/mm3 Leukocytes >3,000/mcL
• Hepatic Total Bilirubin ≤ ULN; AST and ALT and Alkaline Phosphatase within the eligible range
• Renal - creatinine within normal institutional limits or >60 mL/min/1.73 m2 creatinine > institutional normal
• Women of childbearing potential with negative pregnancy test.
• Men and women of childbearing age willing to use effective contraception

You may not qualify if…

• N3 nodal disease according to AJCC guidelines
• Retropharyngeal nodal involvement
• Trismus
• Second primary head and neck tumor unless it is/was a basal or squamous cell skin cancer
• Prior surgery, chemotherapy, biologic or radiotherapy for a head or neck malignancy
• Concurrent investigational agent or intervention (within 90 days of screening visit)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxol, cisplatin, 5- fluorouracil, or carboplatin.
• History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
• Breastfeeding women
• Pre-existing peripheral neuropathy grade > 3
• Evidence of distant metastatic disease
• Unknown primary site
• Prior or concurrent malignancies (excluding adequately treated basal or squamous cell skin cancer, in situ cervical cancer, stage I or II cancer from which the subject has been in complete remission for at least 12 months (excluding head and neck), any cancer from which the subject has been cancer free for 5 years)
• History of allergies to any of the pre-medications.
• Investigator consideration based upon screening interview and/or procedures
• Evidence of bone invasion/destruction
• Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women
• History of HIV, hepatitis B, hepatitis C, or delta antigen
• Known allergy to India Ink or methylene blue

Where it is running

• Southern Illinois University School of Medicine — Springfield, Illinois, United States

Full record on ClinicalTrials.gov

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