Official Title: “Phase I/II Pilot Study of Induction Chemotherapy With Docetaxel in Combination With Cisplatin and 5-Fluorouracil (5-FU) in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)”

The purpose of this study is to determine the appropriate dose, that dose which is found to give maximum effect with limited toxicity, of cisplatin in combination with docetaxel and 5-fluorouracil and then to further define the safety and effectiveness of this combination of medications.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2006

- Treatment begins with a one hour infusion of docetaxel followed by a 1/2 hour infusion of cisplatin. 5-fluorouracil will be administered through continuous IV infusion through a portable pump for four days at home. A cycle is twenty-one days long ( 4 days of chemotherapy and 17 days of recovery). - During each cycle blood tests will be performed weekly. A physical exam will be performed and the impact of the chemotherapy will be assessed at the end of each cycle. - If after 2 cycles the patients cancer has not responded sufficiently they will be removed from the study. - If significant reduction in the size of the tumor is observed after cycle 2, a third and final cycle will be performed. Followed by radiation therapy twice daily for approximately 6-7 weeks.

Intervention(s) in this Clinical Trial

• Drug: Docetaxel
• Drug: Cisplatin
• Drug: 5-Fluorouracil

Primary Measures

• To determine whether cisplatin in combination with docetaxel and 5-fluorouracil can be given with acceptable side effects
• to determine the efficacy of said combination.

Secondary Measures

• To define the safety profile, the dose limiting toxicity and the recommended dose of cisplatin in combination with docetaxel and 5-fluorouracil.

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of head and neck (SSCHN).
• At least one bi- or uni-dimensionally measurable lesion.
• Stage II or IV disease without evidence of distant metastasis.
• No previous chemotherapy, radiotherapy or surgery (other than biopsy) for SSCHN.
• Age greater than 18 years.
• ECOG performance status of 0 or 1.
• Life expectancy of greater than 12 weeks.
• Adequate bone marrow, hepatic and renal function.
• Normal serum calcium

Exclusion Criteria:

• Primary tumor location in nasopharynx, nasal cavity, sinuses, or salivary glands.
• Patients with any non-SSCHN malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix.
• Any prior treatment with chemotherapy.
• Prior radiotherapy to major bone marrow area (> 10% bone marrow) or to head and neck.
• Current peripheral neuropathy of greater than NCI grade 2.
• Other serious illness or medical condition
• Concurrent treatment with corticosteroids unless chronic treatment at low doses.
• Pregnant or lactating females or females of childbearing potential not employing adequate contraception.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Dana-Farber Cancer Institute

Overall Clinical Trial Officials and Contacts

Marshall Posner, MD Principal Investigator Dana-Farbar Cancer Institute  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00139269

Study ID Number: 97-199

ClinicalTrials.gov Identifier: NCT00139269

Health Authority: United States: Food and Drug Administration