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

August 29, 2005
June 2, 2008
February 1998
December 2006   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT00139269 on ClinicalTrials.gov Archive Site
To define the safety profile, the dose limiting toxicity and the recommended dose of cisplatin in combination with docetaxel and 5-fluorouracil.
Same as current
Not Provided
Not Provided
 
Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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)

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.

  • 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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • SSCHN
  • Drug: Docetaxel
  • Drug: Cisplatin
  • Drug: 5-Fluorouracil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
December 2006
December 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00139269
97-199
Not Provided
Not Provided
Dana-Farber Cancer Institute
  • Brigham and Women's Hospital
  • Sanofi
Principal Investigator: Marshall Posner, MD Dana-Farbar Cancer Institute
Dana-Farber Cancer Institute
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP