Clinical trial NCT00139269: Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Squamous Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
SSCHN
Keywords: Advanced Squamous Cell Carcinoma
Squamous cell Carcinoma of Head and Neck
SSCHN
Docetaxel
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Sanofi
First posted: 2005-08-31
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: To determine whether cisplatin in combination with docetaxel and 5-fluorouracil can be given with acceptable side effects
measure: to determine the efficacy of said combination.
Secondary outcomes:
measure: To define the safety profile, the dose limiting toxicity and the recommended dose of cisplatin in combination with docetaxel and 5-fluorouracil.
Other outcomes:
Locations:
Study officials:
affiliation: Dana-Farbar Cancer Institute
name: Marshall Posner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Posner MR, Glisson B, Frenette G, Al-Sarraf M, Colevas AD, Norris CM, Seroskie JD, Shin DM, Olivares R, Garay CA. Multicenter phase I-II trial of docetaxel, cisplatin, and fluorouracil induction chemotherapy for patients with locally advanced squamous cell cancer of the head and neck. J Clin Oncol. 2001 Feb 15;19(4):1096-104. doi: 10.1200/JCO.2001.19.4.1096.
citation: Haddad R, Colevas AD, Tishler R, Busse P, Goguen L, Sullivan C, Norris CM, Lake-Willcutt B, Case MA, Costello R, Posner M. Docetaxel, cisplatin, and 5-fluorouracil-based induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck: the Dana Farber Cancer Institute experience. Cancer. 2003 Jan 15;97(2):412-8. doi: 10.1002/cncr.11063.