Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002774
First received: April 6, 2000
Last updated: February 6, 2009
Last verified: May 2007
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Tirapazamine may increase the effectiveness of chemotherapy and radiation therapy by making tumor cells more sensitive to therapy.

PURPOSE: Randomized phase II trial to compare the effectiveness of radiation therapy with or without combination chemotherapy in treating patients who have stage III or stage IV head and neck cancer.


Condition Intervention Phase
Head and Neck Cancer
Drug: chemosensitization/potentiation therapy
Drug: chemotherapy
Drug: cisplatin
Drug: fluorouracil
Drug: tirapazamine
Radiation: low-LET photon therapy
Radiation: radioisotope therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: RANDOMIZED PHASE II TRIAL OF TIRAPAZAMINE AND THE ROLE OF TUMOR HYPOXIA IN ADVANCED SQUAMOUS HEAD AND NECK CANCER

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 1996
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002774

Locations
United States, California
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, United States, 94304
Stanford University Medical Center
Stanford, California, United States, 94305-5408
Sponsors and Collaborators
Stanford University
Investigators
Study Chair: Harlan A. Pinto, MD Stanford University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00002774     History of Changes
Other Study ID Numbers: CDR0000064752, SUMC-OP-003, NCI-T94-0119O
Study First Received: April 6, 2000
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Tirapazamine
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 15, 2014