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Sponsors and Collaborators: |
Stanford University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002774 |
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 |
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Head and Neck Cancer |
Drug: cisplatin Drug: fluorouracil Drug: tirapazamine Procedure: chemosensitization/potentiation therapy Procedure: chemotherapy Procedure: low-LET photon therapy Procedure: radioisotope therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | RANDOMIZED PHASE II TRIAL OF TIRAPAZAMINE AND THE ROLE OF TUMOR HYPOXIA IN ADVANCED SQUAMOUS HEAD AND NECK CANCER |
Study Start Date: | June 1996 |
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.
Ages Eligible for Study: | 17 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, California | |
Stanford University Medical Center | |
Stanford, California, United States, 94305-5408 | |
Veterans Affairs Medical Center - Palo Alto | |
Palo Alto, California, United States, 94304 |
Study Chair: | Harlan A. Pinto, MD | Stanford University |
Study ID Numbers: | CDR0000064752, SUMC-OP-003, NCI-T94-0119O |
Study First Received: | April 6, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002774 |
Health Authority: | United States: Federal Government |
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 |
Squamous cell carcinoma Dental Caries Recurrence Carcinoma Epidermoid carcinoma Cisplatin Head and Neck Neoplasms |
Metastatic squamous neck cancer with occult primary Fluorouracil Carcinoma, squamous cell Laryngeal carcinoma Hypopharyngeal cancer Tirapazamine Carcinoma, Squamous Cell |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Radiation-Sensitizing Agents Immunologic Factors |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |