Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Completed | any age | NCI | UMCC-8810 NCI-T88-0168C, T88-0168 |
Objectives
I. Determine the complete and partial response rates and the duration of response and survival of patients with locally advanced inoperable squamous cell carcinomas of the head and neck treated with a combination of carboplatin, bleomycin, and radiotherapy. II. Assess the toxicity of the above treatment program.
Entry Criteria
Disease Characteristics:
See General Eligibility Criteria
Patient Characteristics:
See General Eligibility Criteria
General Eligibility Criteria:
Patients of any age with histologically proven, measurable, locally advanced squamous cell carcinoma of the head and neck of any primary site. Acceptable stages are T4, N1-3, A, B, C or T3, N1-3, A, B, C or any T, N3, A, B, C for tumors of the oral cavity, pharynx, larynx, nasopharynx, or paranasal sinuses and Tx, N3, A, B, C for tumors of unknown primary origin. T4 N0 lesions are eligible only if clearly unresectable because of extensive anatomic involvement. There must be no evidence of distant metastatic disease. Patients with locoregional recurrences from any site not previously irradiated and not amenable to salvage surgery are eligible. No prior chemotherapy or radiotherapy is allowed. Karnofsky performance status must be at least 70%, and adequate kidney, bone marrow, and lung function must be demonstrated by the following parameters: BUN 20 mg/dl, creatinine no more than 1.5 mg/dl, and creatinine clearance (optional) greater than 50 ml/minute; WBC at least 3,500, platelets at least 100,000, and hemoglobin at least 9.0 g/dl; and diffusion capacity at least 60% of expected. There must be no evidence of concomitant malignancy other than nonmelanomatous skin cancer (controlled or controllable) or carcinoma in situ of the cervix and no concomitant life-threatening or uncontrolled serious medical illness such as end-stage congestive heart failure, liver disease, or organic brain syndrome.
Expected Enrollment
Initially, 25 patients will be entered over approximately 27 months; if more than 12 responses are observed, 20 more patients will be accrued. Total accrual will be complete in about 2.5 years.
Outline
Nonrandomized study. 2-Drug Combination Chemotherapy plus Radiotherapy. Carboplatin, CBDCA, NSC-241240; Bleomycin, BLEO, NSC-125066; plus tumor irradiation using photon beams and, as indicated, boosts using interstitial Ir192 and/or 6-9 MeV electrons.
Trial Lead Organizations
Greenebaum Cancer Center at University of Maryland Medical Center
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| Mario Eisenberger, MD, Protocol chair (Contact information may not be current) | |
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Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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