- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00318890
Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck
February 2, 2019 updated by: Lisle Nabell, University of Alabama at Birmingham
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
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Docetaxel + cisplatin followed by radiation
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.
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Cisplatin is given at a dose of 75 mg/m2 intravenously for three cycles on Days 1, 21, and 43.
Other Names:
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.
Other Names:
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.
Amifostine will be administered as a subcutaneous injection on a daily basis during radiotherapy.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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approximately 4 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the toxicities of chemotherapy followed by concomitant docetaxel with radiotherapy in patients.
Time Frame: approximately 4 months
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approximately 4 months
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To evaluate tumor specimens for intermediary biomarkers of response or prognosis as compared to normal tissue
Time Frame: approximately 4 months
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approximately 4 months
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To assess the tolerance to subcutaneous amifostine and its effect on saliva production.
Time Frame: approximately 4 months
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approximately 4 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Primary Completion (ACTUAL)
April 1, 2007
Study Completion (ACTUAL)
December 1, 2007
Study Registration Dates
First Submitted
April 25, 2006
First Submitted That Met QC Criteria
April 25, 2006
First Posted (ESTIMATE)
April 27, 2006
Study Record Updates
Last Update Posted (ACTUAL)
February 5, 2019
Last Update Submitted That Met QC Criteria
February 2, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protective Agents
- Radiation-Protective Agents
- Docetaxel
- Cisplatin
- Amifostine
Other Study ID Numbers
- F020522012
- UAB 0210 (OTHER: Institutional study protocol number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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