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RANDOMIZED PHASE II TRIAL OF TIRAPAZAMINE AND THE ROLE OF TUMOR HYPOXIA IN ADVANCED SQUAMOUS HEAD AND NECK CANCER


Phase 2
17 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

RANDOMIZED PHASE II TRIAL OF TIRAPAZAMINE AND THE ROLE OF TUMOR HYPOXIA IN ADVANCED SQUAMOUS HEAD AND NECK CANCER


OBJECTIVES: I. Compare the complete response rate following radiotherapy with or without
tirapazamine (SR-4233) in patients with N1 squamous cell carcinoma of the head and neck. II.
Compare the complete response rate to induction chemotherapy with cisplatin (CDDP) and
fluorouracil (5-FU) with and without SR-4233 followed by concurrent CDDP/5-FU plus
radiotherapy with and without SR-4233 in patients with N2 or N3 squamous cell carcinoma of
the head and neck. III. Assess whether tumor hypoxia contributes to tumor resistance to
treatment by measuring oxygen tension in cervical lymph node metastases and correlating
these results with treatment response in both groups of patients.

OUTLINE: This is a randomized study. Patients are stratified according to pO2 values (high
vs low). Patients are randomized to one of two treatment arms. Arm I: Patients receive
induction chemotherapy consisting of fluorouracil IV continuously on days 1-5 and cisplatin
IV over 4 hours on day 1. Treatment is repeated every 21 days for 2 courses. Patients who
achieve at least partial response proceed to chemoradiotherapy consisting of cisplatin IV
over 30-60 minutes, three times a week, during weeks 1 and 5. Patients also receive
fluorouracil IV continuously for 4 days beginning on day 43 and again on day 71.
Radiotherapy begins on day 43 (week 1) for 5.5 weeks. Patients with no response or
progressive disease after induction chemotherapy proceed to salvage surgery. Arm II:
Patients receive induction chemotherapy as in arm I plus tirapazamine IV over 1.0-2.5 hours
prior to cisplatin. Patients proceed as in arm I. Those patients receiving chemoradiotherapy
also receive tirapazamine IV on the same days as cisplatin. Some patients receive further
radiotherapy and/or surgery. Patients are followed monthly for 1 year, every 2 months for 1
year, every 3 months for 1 year, every 6 months for 2 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study over approximately
5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Biopsy proven squamous cell carcinoma of the following head and
neck sites: Hypopharynx Oral cavity Larynx Oropharynx Nasal cavity Unknown primary
Paranasal sinus Histologically proven poorly differentiated carcinoma of the following
head and neck sites: Hypopharynx Oral cavity Larynx Oropharynx Nasal cavity Paranasal
sinus Stage III/IV (T0-4 N1-3 M0-2) disease

PATIENT CHARACTERISTICS: Age: Over 17 Performance status: ECOG 0-2 Hematopoietic: WBC at
least 3,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST no greater than 100 U/L
Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min
(patients in Group N2-N3) Other: No second malignancy within 5 years except curatively
treated nonmelanomatous skin carcinoma Not pregnant or nursing Negative pregnancy test
required Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No
prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy to
primary tumor allowed No prior radiotherapy to site of metastatic neck disease Surgery:
Prior surgery allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Harlan A. Pinto, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University

Authority:

United States: Federal Government

Study ID:

CDR0000064752

NCT ID:

NCT00002774

Start Date:

June 1996

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • untreated metastatic squamous neck cancer with occult primary
  • recurrent metastatic squamous neck cancer with occult primary
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and 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 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
  • Head and Neck Neoplasms

Name

Location
Stanford University Medical Center Stanford, California  94305-5408
Veterans Affairs Medical Center - Palo Alto Palo Alto, California  94304