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Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Trial of Selenomethionine as a Modulator of Efficacy and Toxicity of Chemoradiation in Locally-Advanced Squamous Cell Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chemotherapeutic Agent Toxicity, Head and Neck Cancer, Mucositis, Radiation Toxicity, Xerostomia

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Trial Information

Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Trial of Selenomethionine as a Modulator of Efficacy and Toxicity of Chemoradiation in Locally-Advanced Squamous Cell Carcinoma of the Head and Neck


OBJECTIVES:

Primary

- Assess whether selenomethionine (SLM) reduces the incidence of grade 3 or 4 mucositis
in patients with locally advanced squamous cell carcinoma of the head and neck treated
with concurrent cisplatin and radiotherapy over 7 weeks.

Secondary

- Assess the impact of SLM on tumor complete response rate, relapse-free survival,
overall survival, and quality of life of these patients.

- Assess whether SLM reduces the incidence and severity of treatment-related toxicities,
including xerostomia, renal impairment, and myelosuppression in these patients.

- Assess whether SLM improves chemoradiotherapy dose delivery in these patients.

- Determine the safety of SLM in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral placebo twice daily in week 1 and then once daily in weeks
2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and
undergo radiotherapy 5 days a week in weeks 2-8.

- Arm II: Patients receive oral selenomethionine twice daily in week 1 and then once
daily in weeks 2-11. Patients also receive cisplatin and radiotherapy as in arm I.

Patients complete quality-of-life questionnaires at baseline and then periodically
thereafter.

After completion of study therapy, patients are followed up periodically.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma (SCC) of the head and neck,
including any of the following sites:

- Oral cavity

- Oropharynx

- Hypopharynx

- Larynx

- Nasopharynx

- Paranasal sinuses

- Locally advanced disease

- Stage III, IVa, or IVb disease

- No non-regional metastatic disease (stage IVc)

- Appropriate candidate for concurrent cisplatin and radiotherapy as definitive
treatment

- Patients who receive induction chemotherapy as part of a definitive treatment
program that will include concurrent cisplatin and radiotherapy are eligible

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- ANC ≥ 2,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10 g/dL

- Serum creatinine ≤ 1.5 mg/dL (133 μmol/L) OR creatinine clearance ≥ 50 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to tolerate oral medications OR has a feeding tube in place

- Willing and able to comply with study procedures

- No other malignancy within the past 5 years except for adequately treated basal cell
or squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia

- No known hepatitis C or HIV positivity

- No symptomatic peripheral neuropathy ≥ NCI-CTCAE grade 2

- No history of hypersensitivity to platinum drugs

- No concurrent uncontrolled illness including, but not limited to, any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Clinically significant cardiac arrhythmia

- Psychiatric illness or social situation that would limit compliance with study
requirements

- No evidence of any other significant medical disorder or laboratory finding that, in
the opinion of the investigator, would compromise the patient's safety during the
study

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior definitive surgery for SCC of the head and neck

- No prior radiotherapy for SCC of the head and neck

- No prior radiotherapy that would compromise delivery of a radical dose to SCC of the
head and neck

- No concurrent amifostine for prophylaxis against radiation-induced xerostomia

- No concurrent selenium supplements > 100 μg/day

- No other concurrent chemotherapy

- No concurrent hormonal therapy, except steroids for adrenal failure or septic shock,
hormones for non-disease-related conditions (e.g., insulin for diabetes or
L-thyroxine for hypothyroidism), or glucocorticosteroids as antiemetics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Incidence of ≥ grade 3 mucositis

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Anurag Singh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000647812

NCT ID:

NCT00935038

Start Date:

June 2009

Completion Date:

Related Keywords:

  • Chemotherapeutic Agent Toxicity
  • Head and Neck Cancer
  • Mucositis
  • Radiation Toxicity
  • Xerostomia
  • mucositis
  • xerostomia
  • chemotherapeutic agent toxicity
  • radiation toxicity
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Xerostomia
  • Radiation Injuries
  • Mucositis

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263