Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
NCT ID: NCT00139243
Last Updated: 2008-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
1997-10-31
2006-01-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Taxotere
Cisplatin
5-Fluorouracil
Leucovorin
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Brigham and Women's Hospital
OTHER
Massachusetts General Hospital
OTHER
Beth Israel Deaconess Medical Center
OTHER
Dana-Farber Cancer Institute
OTHER
Principal Investigators
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Marshall Posner, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
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.
Other Identifiers
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97-130
Identifier Type: -
Identifier Source: org_study_id