Combination Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT00139230 | Completed Phase 2

• 1 other identifier: 96-184
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to further test a combination chemotherapy regimen for the treatment of squamous cell carcinoma of the head and neck and to see if the addition of supportive medicine can help reduce the side effects of these drugs.

Conditions

Squamous Cell Carcinoma; Carcinoma of Head/Neck

Keywords

Squamous Cell Carcinoma of Head and Neck; Compressed TPFL; Taxotere; Growth Factor Support

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of a four day regimen of taxotere, cisplatin, 5-fluorouracil and high-dose leucovorin with growth factor support and ciprofloxacin.

Secondary Outcomes (1)

• To determine the efficacy of this regimen in patients with advances, previously untreated squamous cell carcinoma of the head and neck.

Interventions

Taxotere DRUG

Cisplatin DRUG

5-Fluorouracil DRUG

Leucovorin DRUG

G-CSF DRUG

Ciprofloxacin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic confirmation of squamous cell carcinoma of head and neck.
• 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.

You may not qualify if:

• Patients with previous head and neck cancer except those treated with surgery only.
• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator
• Sanofi: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• 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.

  PMID: 12518365 BACKGROUND

• 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.

  PMID: 11943893 BACKGROUND

• 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.

  PMID: 16702569 BACKGROUND

• 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.

  PMID: 16785415 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck

Interventions

Docetaxel; Cisplatin; Fluorouracil; Leucovorin; Granulocyte Colony-Stimulating Factor; Ciprofloxacin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Marshall Posner, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 31, 2005
• Study Start: January 1, 1997
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: June 3, 2008

Record last verified: 2008-06

Locations

US (2)