Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck - Full Text View

Purpose

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.

Condition	Intervention	Phase
Advanced Squamous Cell Carcinoma Squamous Cell Carcinoma of Head and Neck SSCHN	Drug: Docetaxel Drug: Cisplatin Drug: 5-Fluorouracil	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Cisplatin Docetaxel

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine whether cisplatin in combination with docetaxel and 5-fluorouracil can be given with acceptable side effects
to determine the efficacy of said combination.

Secondary Outcome Measures:

To define the safety profile, the dose limiting toxicity and the recommended dose of cisplatin in combination with docetaxel and 5-fluorouracil.

Estimated Enrollment:	38
Study Start Date:	February 1998
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139269

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Sanofi

Investigators

Principal Investigator:

Marshall Posner, MD

Dana-Farbar Cancer Institute

More Information

Publications:

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.

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.

ClinicalTrials.gov Identifier:	NCT00139269 History of Changes
Other Study ID Numbers:	97-199
Study First Received:	August 29, 2005
Last Updated:	June 2, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

Advanced Squamous Cell Carcinoma
Squamous cell Carcinoma of Head and Neck
SSCHN
Docetaxel

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
Cisplatin
Fluorouracil

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013