Combination Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
NCT ID: NCT00139230
Last Updated: 2008-06-03
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
PHASE2
30 participants
INTERVENTIONAL
1997-01-31
2006-12-31
Brief Summary
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Detailed Description
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* Approximately 6-12 hours after the chemotherapy ends patients will be given growth factor support and ciprofloxacin until the patient's ANC level is greater than 10,000.
* Infusion of chemotherapy will be repeated every 28 days (1 cycle is 28 days).
* During each cycle patients will have blood tests performed weekly and may be asked to return to the Head and Neck Clinic for examination around the middle of each cycle.
* At the end of each cycle the impact of the chemotherapy will be assessed. If after 2 cycles, the cancer has not responded sufficiently the patient will not receive any more chemotherapy. However, if significant reduction in the size of the patients tumor is observed, a third and final cycle will be performed.
* During the fourth or fifth week of cycle 3, patients will undergo re-staging evaluation under anesthesia with primary-site biopsies and planning of radiotherapy.
* Within 2 weeks of completion of chemotherapy cycle 3 all patients will receive twice daily radiotherapy.
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
G-CSF
Ciprofloxacin
Eligibility Criteria
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Inclusion Criteria
* All patients with previously untreated Stage III or IV.
* Measurable disease
* Complete recovery from previous diagnostic or therapeutic procedures.
* Life expectancy greater than 3 months
* Creatinine less than or equal to 1.5
* SGOT less than 1.5 x ULN
* Alkaline phosphatase less than 2.5 x ULN
* WBC greater than or equal to 4,000/mm
* Platelet count greater than to equal to 100,000/mm
* Hemoglobin greater than or equal to 10gm/dl
* Patients of childbearing age must use effective contraception methods.
Exclusion Criteria
* Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
* Peripheral neuropathy exceeding grade 1.
* Cardiovascular or pulmonary disease
* Pregnant or breastfeeding women
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Massachusetts General Hospital
OTHER
Sanofi
INDUSTRY
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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Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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References
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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.
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.
Goguen LA, Posner MR, Tishler RB, Wirth LJ, Norris CM, Annino DJ, Sullivan CA, Li Y, Haddad RI. Examining the need for neck dissection in the era of chemoradiation therapy for advanced head and neck cancer. Arch Otolaryngol Head Neck Surg. 2006 May;132(5):526-31. doi: 10.1001/archotol.132.5.526.
Haddad R, Tishler R, Wirth L, Norris CM, Goguen L, Sullivan C, O'Donnell L, Li Y, Posner M. Rate of pathologic complete responses to docetaxel, cisplatin, and fluorouracil induction chemotherapy in patients with squamous cell carcinoma of the head and neck. Arch Otolaryngol Head Neck Surg. 2006 Jun;132(6):678-81. doi: 10.1001/archotol.132.6.678.
Other Identifiers
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96-184
Identifier Type: -
Identifier Source: org_study_id