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

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Sanofi
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00139269
First received: August 29, 2005
Last updated: June 2, 2008
Last verified: June 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 20, 2014