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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Sanofi
• Treatments: Cisplatin; Docetaxel; Fluorouracil

Criteria

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.