Clinical trial NCT00139243: Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
Official title: A Phase I/II Study of Taxotere, Cisplatin, 5-Fluorouracil and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Squamous Cell Carcinoma
Carcinoma of Head and/or Neck
Keywords: squamous cell carcinoma
Taxotere
carcinoma of head/neck
Cisplatin
5-Fluorouracil
Leucovorin
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Brigham and Women's Hospital
name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
First posted: 2005-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and maximum tolerated dose of the combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily assess whether the combination is effective in treating squamous cell carcinoma of the head and neck.

Detailed description: * Patients will be premedicated at home with dexamethasone and leucovorin.
* On the first day of treatment, the patient will receive taxotere intravenously for one hour. Approximately one hour after the taxotere is completed, the patient will receive a 4 hour infusion of cisplatin and begin a four day continuous infusion of 5-fluorouracil and leucovorin. The infusion of 5-fluorouracil and leucovorin will be completed at home with the use of an infusion pump. This process will be repeated every 21-35 days (1 cycle) depending upon how quickly the patient recovers from the chemotherapy.
* During each cycle blood tests will be performed weekly. During the first cycle a physical exam will be performed weekly and then halfway through each subsequent cycle and immediately prior to the start of each subsequent cycle.
* At the end of each cycle the impact of the chemotherapy will be assessed. If after 2 cycles the cancer has not responded the treatment will end. If significant reduction in the size of the tumor is observed, a third and final cycle will be done.
* After the last cycle of chemotherapy is done, radiation therapy will be performed twice daily for 6-7 weeks.

Eligibility criteria: Inclusion Criteria:

* Histologic documentation of squamous cell carcinoma of head and neck
* Patients will previously untreated stage III or IV squamous cell carcinoma.
* Patients with locally recurrent disease after surgery.
* Life expectancy of longer than 3 months.
* Kidney function: 1.5 or a 24 hour creatinine clearance of \> 30ml/min
* Liver function: SGOT \< 1.5 X upper normal limit and alkaline phosphatase of \< 2.5 X upper normal limit.
* WBC greater than or equal to 4,000/mm
* Platelet count greater than or equal to 100,000/mm
* Hemoglobin greater than or equal to 10gm/dl
* Patients of child-bearing age must use effective methods of contraception.

Exclusion Criteria:

* Patients treated with previous chemotherapy or radiotherapy for head and neck cancer.
* Patients with concurrent malignancy of any site except limited basal cell carcinoma, squamous carcinoma of the skin or carcinoma in situ of the cervix.
* Pregnant or breast-feeding women

Primary outcomes:
measure: To determine the maximum tolerated dose of taxotere, cisplatin, 5-fluorouracil and leucovorin.
Secondary outcomes:
measure: To evaluate the side effects of a four day outpatient regimen with taxotere, cisplatin, 5-fluorouracil and leucovorin
measure: to obtain preliminary information about the effectiveness of the drug combination.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Marshall Posner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colevas AD, Norris CM, Tishler RB, Lamb CC, Fried MP, Goguen LA, Gopal HV, Costello R, Read R, Adak S, Posner MR. Phase I/II trial of outpatient docetaxel, cisplatin, 5-fluorouracil, leucovorin (opTPFL) as induction for squamous cell carcinoma of the head and neck (SCCHN). Am J Clin Oncol. 2002 Apr;25(2):153-9. doi: 10.1097/00000421-200204000-00010.
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.