Phase II Study of Combination Chemotherapy with BLEO/CBDCA plus Radiotherapy in the Primary Management of Patients with Locally Advanced Inoperable Squamous Cell Carcinomas of the Head and Neck (Summary Last Modified 07/89)

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentCompletedany ageNCIUMCC-8810
NCI-T88-0168C, T88-0168


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.


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 

Trial Contact Information

Trial Lead Organizations

Greenebaum Cancer Center at University of Maryland Medical Center

Mario Eisenberger, MD, Protocol chair (Contact information may not be current)
Ph: 410-328-2565; 800-888-8823

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.