Status:
COMPLETED
Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Sanofi
Conditions:
Advanced Squamous Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 1998
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00139269
Start Date
February 1 1998
End Date
December 1 2006
Last Update
June 4 2008
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