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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

Phase 1/Phase 2
19 Years
Not Enrolling
Cancer of Head and Neck, Head Cancer, Head and Neck Cancer, Neck Cancer, Neck Neoplasms

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Trial Information

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

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.

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 <

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the response rate to chemotherapy followed by docetaxel with radiotherapy and to assess overall survival, local-regional recurrence rate and effects on the quality of life.

Outcome Time Frame:

approximately 4 months

Safety Issue:


Principal Investigator

Lisle Nabell, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham


United States: Institutional Review Board

Study ID:




Start Date:

October 2002

Completion Date:

December 2007

Related Keywords:

  • Cancer of Head and Neck
  • Head Cancer
  • Head and Neck Cancer
  • Neck Cancer
  • Neck Neoplasms
  • Chemotherapy and Radiotherapy for Head and Neck Cancer
  • Chemotherapy, Radiotherapy Squamous Cell Carcinoma Head Neck
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



University of Alabama at Birmingham Birmingham, Alabama  35294-3300