Status:
COMPLETED
Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Aventis Pharmaceuticals
Conditions:
Cancer of Head and Neck
Head Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief Summary
This trial seeks to accomplish both local and regional control of head and neck cancer and reduce systemic metastatic disease. To do this, patients will received chemotherapy followed by chemotherapy ...
Detailed Description
The majority of head and neck cancer patients present with more advanced stages III or IV disease. The treatment of cancers of the head and neck can have profound consequences with regard to functiona...
Eligibility Criteria
Inclusion
- The patient has histologically proven primary or recurrent squamous cell carcinoma arising in the oropharynx, oral cavity, hypopharynx, larynx, or nasopharynx.
- The patient has stage III or IV disease.
- Performance status \< 2 (ECOG scale) with a life expectancy of \> 12 months.
- Age 19 years and above.
- The patient is medically fit to tolerate a course of definitive radiation therapy.
- The patient has:
- adequate hepatic function with bilirubin \< upper limit of normal (ULN)
- transaminases (SGOT and SGPT) may be up to 2.5 x ULN if alkaline phosphatase is \< ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are \< ULN
- adequate renal function with serum creatinine \< 1.5 mg/dl (or estimated creatinine clearance of \> 50 mL/min)
- normal serum calcium
- adequate hematologic function as: defined by an absolute neutrophil count \> 1500/ml, hemoglobin \> 8.0 g/dl, and platelet count \> 100,000/ml.
- The patient may have had a prior malignancy but must be three years from treatment.
- A history of superficial non-melanoma skin cancer or in situ carcinoma of the cervix less then three years will be allowed.
- The patient must agree to use effective contraception if procreative potential exists, and continue contraception for at least 6 months following completion of the study.
- Patient must sign informed consent.
Exclusion
- The patient has received radiation therapy previously to the head and neck.
- The patient has received prior chemotherapy for head and neck cancer.
- The patient is pregnant or lactating.
- Peripheral neuropathy \> Grade 2.
- Serious non-malignant disease (e.g. congestive heart failure, uncontrolled atrial fibrillation, active hepatitis).
- Any underlying psychological condition that would prohibit the understanding and rendering of informed consent.
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 must be excluded.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00318890
Start Date
October 1 2002
End Date
December 1 2007
Last Update
February 5 2019
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294