Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck - Full Text View

Sponsor:	University of Alabama at Birmingham
Collaborator:	Aventis Pharmaceuticals
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 Drug: Amifostine	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:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Cisplatin Amifostine Docetaxel

U.S. FDA Resources

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

Primary Outcome Measures:

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. [ Time Frame: approximately 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the toxicities of chemotherapy followed by concomitant docetaxel with radiotherapy in patients. [ Time Frame: approximately 4 months ] [ Designated as safety issue: Yes ]
To evaluate tumor specimens for intermediary biomarkers of response or prognosis as compared to normal tissue [ Time Frame: approximately 4 months ] [ Designated as safety issue: No ]
To assess the tolerance to subcutaneous amifostine and its effect on saliva production. [ Time Frame: approximately 4 months ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	October 2002
Study Completion Date:	December 2009
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Docetaxel + cisplatin followed by radiation: Experimental Docetaxel with cisplatin is given for three cycles, followed by concomitant therapy with weekly docetaxel for 4 weeks. Radiation therapy is given 5 days each week on Days 64-106 with a concomitant boost in the last 2 weeks of treatment. Amifostine is given as an injection on a daily basis during radiotherapy.	Drug: Cisplatin Cisplatin is given at a dose of 75 mg/m2 intravenously for three cycles on Days 1, 21, and 43. Drug: Docetaxel Docetaxel is given at a dose of 75 mg/m2 intravenously on Days 1, 21, and 43 and continued at variable doses for 4 weeks with standard radiotherapy. Procedure: Radiotherapy Radiation therapy will be given 5 days each week for 4 weeks plus a concomitant boost in the last 2 weeks of treatment to deliver 54 Gy in 30 fractions. Radiotherapy will follow the induction chemotherapy with docetaxel and cisplatin. Drug: Amifostine Amifostine will be administered as a subcutaneous injection on a daily basis during radiotherapy.

Arms

Assigned Interventions

Docetaxel + cisplatin followed by radiation: Experimental

Docetaxel with cisplatin is given for three cycles, followed by concomitant therapy with weekly docetaxel for 4 weeks. Radiation therapy is given 5 days each week on Days 64-106 with a concomitant boost in the last 2 weeks of treatment. Amifostine is given as an injection on a daily basis during radiotherapy.

Drug: Cisplatin

Cisplatin is given at a dose of 75 mg/m2 intravenously for three cycles on Days 1, 21, and 43.

Drug: Docetaxel

Docetaxel is given at a dose of 75 mg/m2 intravenously on Days 1, 21, and 43 and continued at variable doses for 4 weeks with standard radiotherapy.

Procedure: Radiotherapy

Radiation therapy will be given 5 days each week for 4 weeks plus a concomitant boost in the last 2 weeks of treatment to deliver 54 Gy in 30 fractions. Radiotherapy will follow the induction chemotherapy with docetaxel and cisplatin.

Drug: Amifostine

Amifostine will be administered as a subcutaneous injection on a daily basis during radiotherapy.

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

Aventis Pharmaceuticals

Investigators

Principal Investigator:

Lisle Nabell, M.D.

University of Alabama at Birmingham

More Information

No publications provided

Responsible Party:	University of Alabama at Birmingham ( Lisle Nabell, M.D./ PI )
Study ID Numbers:	F020522012, UAB 0210
Study First Received:	April 25, 2006
Last Updated:	December 24, 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

Additional relevant MeSH terms:

Radiation-Protective Agents
Neoplasms by Histologic Type
Amifostine
Antineoplastic Agents
Physiological Effects of Drugs
Protective Agents
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 February 08, 2010