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Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck

Primary Purpose

Cancer of Head and Neck, Head Cancer, Head and Neck Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Docetaxel
Radiotherapy
Amifostine
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer of Head and Neck focused on measuring Chemotherapy and Radiotherapy for Head and Neck Cancer, Chemotherapy, Radiotherapy Squamous Cell Carcinoma Head Neck

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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 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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel + cisplatin followed by radiation

Arm Description

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.

Outcomes

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.

Secondary Outcome Measures

To evaluate the toxicities of chemotherapy followed by concomitant docetaxel with radiotherapy in patients.
To evaluate tumor specimens for intermediary biomarkers of response or prognosis as compared to normal tissue
To assess the tolerance to subcutaneous amifostine and its effect on saliva production.

Full Information

First Posted
April 25, 2006
Last Updated
February 2, 2019
Sponsor
University of Alabama at Birmingham
Collaborators
Aventis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00318890
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Aventis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel + cisplatin followed by radiation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Platinol-AQ
Intervention Description
Cisplatin is given at a dose of 75 mg/m2 intravenously for three cycles on Days 1, 21, and 43.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Radiotherapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Amifostine
Other Intervention Name(s)
Ethyol
Intervention Description
Amifostine will be administered as a subcutaneous injection on a daily basis during radiotherapy.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To evaluate the toxicities of chemotherapy followed by concomitant docetaxel with radiotherapy in patients.
Time Frame
approximately 4 months
Title
To evaluate tumor specimens for intermediary biomarkers of response or prognosis as compared to normal tissue
Time Frame
approximately 4 months
Title
To assess the tolerance to subcutaneous amifostine and its effect on saliva production.
Time Frame
approximately 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisle Nabell, M.D.
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

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Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck

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