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Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck
This study has been completed.
First Received: April 25, 2006   Last Updated: August 6, 2009   History of Changes
Sponsored by: University of Alabama at Birmingham
Information provided by: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00318890
  Purpose

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 and radiation (given together) with an escalating dose of docetaxel.


Condition Intervention Phase
Cancer of Head and Neck
Head Cancer
Head and Neck Cancer
Neck Cancer
Neck Neoplasms
Drug: Cisplatin
Drug: Docetaxel
Procedure: Radiotherapy
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Trial of Induction Cisplatin and Docetaxel Followed by Concomitant Docetaxel/Radiotherapy With Subcutaneous Amifostine for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Estimated Enrollment: 15
Study Start Date: October 2002
Study Completion Date: April 2007
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 functional abilities such as speech and eating. In the treatment of both locally advanced HNSCC and sites where organ preservation is desirable, radiation therapy has been a major method of treatment. However, as a single modality, radiation therapy can cure fewer than 30% of patients with advanced disease. Attempts to improve the outcome of locally advanced HNSCC have generally added chemotherapy to radiotherapy. However, the optimal manner to integrate chemotherapy into the plan of care has been controversial. Chemotherapy has been used most commonly as either induction therapy preceding radiation, or more recently as concomitant therapy along with radiation. Induction chemotherapy has been associated with high response rates of 60-90%, but no significant change in loco-regional control or survival.Clinical trials incorporating chemotherapy with concurrent radiation have recently generated considerable interest. To accomplish both loco-regional control and reduce systemic metastasis, this trial proposes induction chemotherapy followed by concomitant chemotherapy-radiation with an escalating dose of docetaxel in patients with locally advanced previously untreated HNSCC.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. adequate hepatic function with bilirubin < upper limit of normal (ULN)
    2. 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
    3. adequate renal function with serum creatinine < 1.5 mg/dl (or estimated creatinine clearance of > 50 mL/min)
    4. normal serum calcium
    5. 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 Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318890

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Lisle Nabell, M.D. University of Alabama at Birmingham
  More Information

No publications provided

Study ID Numbers: F020522012, UAB 0210
Study First Received: April 25, 2006
Last Updated: August 6, 2009
ClinicalTrials.gov Identifier: NCT00318890     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Chemotherapy and Radiotherapy for Head and Neck Cancer
Chemotherapy, Radiotherapy Squamous Cell Carcinoma Head Neck

Study placed in the following topic categories:
Docetaxel
Radiation-Sensitizing Agents
Amifostine
Cisplatin
Head and Neck Neoplasms
Epidermoid Carcinoma
Carcinoma, Squamous Cell of Head and Neck
Neoplasms, Squamous Cell
Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Carcinoma
Docetaxel
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Head and Neck Neoplasms
Therapeutic Uses
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on August 30, 2009