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

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ClinicalTrials.gov Identifier: NCT00139269
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : June 4, 2008
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Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Squamous Cell Carcinoma Squamous Cell Carcinoma of Head and Neck SSCHN Drug: Docetaxel Drug: Cisplatin Drug: 5-Fluorouracil Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : February 1998
Primary Completion Date : December 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139269

Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Marshall Posner, MD Dana-Farbar Cancer Institute
More Information

ClinicalTrials.gov Identifier: NCT00139269     History of Changes
Other Study ID Numbers: 97-199
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008

Keywords provided by Dana-Farber Cancer Institute:
Advanced Squamous Cell Carcinoma
Squamous cell Carcinoma of Head and Neck

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs