Clinical trial NCT00318890: Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cancer of Head and Neck
Head Cancer
Head and Neck Cancer
Neck Cancer
Neck Neoplasms
Keywords: Chemotherapy and Radiotherapy for Head and Neck Cancer
Chemotherapy, Radiotherapy Squamous Cell Carcinoma Head Neck
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
First posted: 2006-04-27
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
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.
timeFrame: approximately 4 months
Secondary outcomes:
measure: To evaluate the toxicities of chemotherapy followed by concomitant docetaxel with radiotherapy in patients.
timeFrame: approximately 4 months
measure: To evaluate tumor specimens for intermediary biomarkers of response or prognosis as compared to normal tissue
timeFrame: approximately 4 months
measure: To assess the tolerance to subcutaneous amifostine and its effect on saliva production.
timeFrame: approximately 4 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Lisle Nabell, M.D.
role: PRINCIPAL_INVESTIGATOR
References: