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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Drug/Agent Toxicity by Tissue/Organ, Head and Neck Cancer, Radiation Toxicity

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Fred R. Rosen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Illinois

Authority:

United States: Federal Government

Study ID:

CDR0000066133

NCT ID:

NCT00003251

Start Date:

December 1997

Completion Date:

Related Keywords:

  • Drug/Agent Toxicity by Tissue/Organ
  • Head and Neck Cancer
  • Radiation Toxicity
  • 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
  • Head and Neck Neoplasms
  • Radiation Injuries

Name

Location

University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612