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)
18 Years
N/A
Both
Advanced Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, SSCHN
Trial Information
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)
- 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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine whether cisplatin in combination with docetaxel and 5-fluorouracil can be given with acceptable side effects
Principal Investigator
Marshall Posner, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farbar Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
97-199
NCT ID:
NCT00139269
Start Date:
February 1998
Completion Date:
December 2006
Related Keywords:
- Advanced Squamous Cell Carcinoma
- Squamous Cell Carcinoma of Head and Neck
- SSCHN
- Advanced Squamous Cell Carcinoma
- Squamous cell Carcinoma of Head and Neck
- SSCHN
- Docetaxel
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
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