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

Primary Purpose

Drug/Agent Toxicity by Tissue/Organ, Head and Neck Cancer, Radiation Toxicity

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

amifostine trihydrate

cisplatin

paclitaxel

radiation therapy

About this trial

This is an interventional supportive care trial for Drug/Agent Toxicity by Tissue/Organ focused on measuring 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, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, drug/agent toxicity by tissue/organ, radiation toxicity

Eligibility Criteria

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

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

Sites / Locations

University of Illinois at Chicago Health Sciences Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003251

First Posted

November 1, 1999

Last Updated

December 3, 2013

Sponsor

University of Illinois at Chicago

1. Study Identification

Unique Protocol Identification Number

NCT00003251

Brief Title

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

Official Title

A Pilot Study of Amifostine and Concomitant Cisplatin, Paclitaxel and Radiotherapy in Previously Irradiated, Recurrent Head and Neck Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

June 2000

Overall Recruitment Status

Unknown status

Study Start Date

December 1997 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Illinois at Chicago

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

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

Drug/Agent Toxicity by Tissue/Organ, Head and Neck Cancer, Radiation Toxicity

Keywords

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, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, drug/agent toxicity by tissue/organ, radiation toxicity

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1, Phase 2

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

amifostine trihydrate

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

paclitaxel

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fred R. Rosen, MD

Organizational Affiliation

University of Illinois at Chicago

Official's Role

Study Chair

Facility Information:

Facility Name

University of Illinois at Chicago Health Sciences Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

12. IPD Sharing Statement

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

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