Back to resultsStudy of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Primary Purpose
Advanced Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, SSCHN
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Docetaxel
Cisplatin
5-Fluorouracil
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Squamous Cell Carcinoma focused on measuring Advanced Squamous Cell Carcinoma, Squamous cell Carcinoma of Head and Neck, SSCHN, Docetaxel
Eligibility 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.
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00139269
First Posted
August 29, 2005
Last Updated
June 2, 2008
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT00139269
Brief Title
Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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 Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Sanofi
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Squamous Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck, SSCHN
Keywords
Advanced Squamous Cell Carcinoma, Squamous cell Carcinoma of Head and Neck, SSCHN, Docetaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil
Primary Outcome Measure Information:
Title
To determine whether cisplatin in combination with docetaxel and 5-fluorouracil can be given with acceptable side effects
Title
to determine the efficacy of said combination.
Secondary Outcome Measure Information:
Title
To define the safety profile, the dose limiting toxicity and the recommended dose of cisplatin in combination with docetaxel and 5-fluorouracil.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marshall Posner, MD
Organizational Affiliation
Dana-Farbar Cancer Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
11181674
Citation
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. doi: 10.1200/JCO.2001.19.4.1096.
Results Reference
background
PubMed Identifier
12518365
Citation
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.
Results Reference
background
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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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