Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Phase 1

Completed

• Conditions: Advanced Squamous Cell Carcinoma; Squamous Cell Carcinoma of Head and Neck; SSCHN

• Registration Number: NCT00139269
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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.

Detailed Description

* 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.

Study Timeline

• Study Start: 1998-02
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-31
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-02
• Last Update Posted: 2008-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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