Amifostine Plus Chemotherapy and Radiation Therapy in Treating Patients With Advanced, Unresectable Head and Neck Cancer

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. Identifier: NCT00003251
Recruitment Status : Unknown
Verified June 2000 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : August 13, 2004
Last Update Posted : December 4, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy and radiation therapy.

PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus cisplatin, paclitaxel, and radiation therapy in treating patients who have advanced unresectable head and neck cancer.

Condition or disease Intervention/treatment Phase
Drug/Agent Toxicity by Tissue/Organ Head and Neck Cancer Radiation Toxicity Drug: amifostine trihydrate Drug: cisplatin Drug: paclitaxel Radiation: radiation therapy Phase 1 Phase 2

Detailed Description:

OBJECTIVES: I. Assess the efficacy and role of amifostine as a cytoprotection agent with concurrent chemoradiotherapy in advanced, previously irradiated or metastatic head and neck cancer. II. Determine the toxicity and response to cisplatin, paclitaxel and radiation therapy in these patients. III. Determine the toxicity of amifostine in these patients.

OUTLINE: This is an open label study. Patients receive paclitaxel by continuous infusion on days 0-3. Amifostine IV is administered over 5 minutes on days 1-5. Radiation therapy is administered once daily on days 1-5. Cisplatin IV is administered on day 5. Patients receive no treatment on days 6-13. Treatment is repeated every 2 weeks for up to 7 courses in the absence of disease progression and unacceptable toxicity. Patients are followed monthly during the first year, every 2 months during the second year, then every 3 months thereafter.

PROJECTED ACCRUAL: This study will accrue 16-46 patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Amifostine and Concomitant Cisplatin, Paclitaxel and Radiotherapy in Previously Irradiated, Recurrent Head and Neck Cancer
Study Start Date : December 1997

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically or cytologically documented metastatic or previously irradiated recurrent locoregional squamous cell or mucoepidermoid carcinoma of the head and neck Unresectable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 70-100% Life expectancy: Greater than 4 months Hematopoietic: WBC at least 3000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1500/mm3 Hepatic: Bilirubin no greater than 2.5 times normal SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min Other: No other significant infection No other medical or psychiatric illness Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 month since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 months since prior radiotherapy (patients with recurrent disease) to head and neck region Surgery: Not speciified Other: At least 24 hours since antihypertensive medication

Information from the National Library of Medicine

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 identifier (NCT number): NCT00003251

United States, Illinois
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Study Chair: Fred R. Rosen, MD University of Illinois at Chicago Identifier: NCT00003251     History of Changes
Other Study ID Numbers: CDR0000066133
First Posted: August 13, 2004    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: June 2000

Keywords provided by National Cancer Institute (NCI):
stage III nasopharyngeal cancer
stage IV nasopharyngeal cancer
recurrent nasopharyngeal cancer
stage III salivary gland cancer
stage IV salivary gland cancer
recurrent salivary gland cancer
salivary gland squamous cell carcinoma
high-grade salivary gland mucoepidermoid carcinoma
stage III lip and oral cavity cancer
stage IV lip and oral cavity cancer
recurrent lip and oral cavity cancer
stage III hypopharyngeal cancer
stage IV hypopharyngeal cancer
recurrent hypopharyngeal cancer
stage III laryngeal cancer
stage IV laryngeal cancer
recurrent laryngeal cancer
stage III paranasal sinus and nasal cavity cancer
stage IV paranasal sinus and nasal cavity cancer
recurrent paranasal sinus and nasal cavity cancer
stage III oropharyngeal cancer
stage IV oropharyngeal cancer
recurrent oropharyngeal cancer
stage III squamous cell carcinoma of the lip and oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
stage III squamous cell carcinoma of the oropharynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Radiation Injuries
Neoplasms by Site
Wounds and Injuries
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs