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

NCT00318890 | Completed Phase 1 DMC

• 2 other identifiers: F020522012UAB 0210
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  approximately 4 months

Secondary Outcomes (3)

• To evaluate the toxicities of chemotherapy followed by concomitant docetaxel with radiotherapy in patients.

  approximately 4 months

• To evaluate tumor specimens for intermediary biomarkers of response or prognosis as compared to normal tissue

  approximately 4 months

• To assess the tolerance to subcutaneous amifostine and its effect on saliva production.

  approximately 4 months

Study Arms (1)

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; Drug: Docetaxel; Procedure: Radiotherapy; Drug: Amifostine

Interventions

Cisplatin DRUG

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

Also known as: Platinol-AQ

Docetaxel + cisplatin followed by radiation

Docetaxel DRUG

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.

Also known as: Taxotere

Docetaxel + cisplatin followed by radiation

Radiotherapy PROCEDURE

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.

Docetaxel + cisplatin followed by radiation

Amifostine DRUG

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

Also known as: Ethyol

Docetaxel + cisplatin followed by radiation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Aventis Pharmaceuticals: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cisplatin; Docetaxel; Radiotherapy; Amifostine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics; Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organothiophosphorus Compounds; Sulfur Compounds

Study Officials

• Lisle Nabell, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: April 25, 2006
• First Posted: April 27, 2006
• Study Start: October 1, 2002
• Primary Completion: April 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

US (1)