Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00318890 |
Recruitment Status
:
Completed
First Posted
: April 27, 2006
Last Update Posted
: February 14, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | 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 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | October 2002 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | December 2007 |

Arm | Intervention/treatment |
---|---|
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.
|
Drug: Cisplatin
Cisplatin is given at a dose of 75 mg/m2 intravenously for three cycles on Days 1, 21, and 43.
Other Name: Platinol-AQ
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.
Other Name: Taxotere
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.
Other Name: Ethyol
|
- 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 ]
- To evaluate the toxicities of chemotherapy followed by concomitant docetaxel with radiotherapy in patients. [ Time Frame: approximately 4 months ]
- To evaluate tumor specimens for intermediary biomarkers of response or prognosis as compared to normal tissue [ Time Frame: approximately 4 months ]
- To assess the tolerance to subcutaneous amifostine and its effect on saliva production. [ Time Frame: approximately 4 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318890
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 |
Principal Investigator: | Lisle Nabell, M.D. | University of Alabama at Birmingham |
Responsible Party: | Lisle Nabell, M.D./ PI, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00318890 History of Changes |
Other Study ID Numbers: |
F020522012 UAB 0210 ( Other Identifier: Institutional study protocol number ) |
First Posted: | April 27, 2006 Key Record Dates |
Last Update Posted: | February 14, 2011 |
Last Verified: | February 2011 |
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:
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site Docetaxel Cisplatin |
Amifostine Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Radiation-Protective Agents Protective Agents Physiological Effects of Drugs |