|
||||||||||||||||||||||
![]() |
|
|
|
![]() |
Phase II Chemotherapy with Amonafide in Patients with Advanced Squamous Cell Carcinoma of the Head and Neck (Summary Last Modified 12/91)
Basic Trial Information
Objectives I. Assess the usefulness of amonafide in the treatment of squamous cell carcinoma of the head and neck. II. Add to the accumulated knowledge of the toxicity of amonafide. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients at least 16 years of age with histologically confirmed squamous cell carcinoma of the head and neck that is either 1) recurrent or metastatic or 2) locally advanced, and is judged incurable by surgery or radiotherapy. Patients may have received no more than one prior adjuvant/neoadjuvant chemotherapy regimen, with no evidence of progressive or recurrent disease during the course of that treatment; no more than one prior immunotherapy regimen is allowed. At least 28 days must have elapsed since any prior chemotherapy, immunotherapy, or radiotherapy. Bidimensionally measurable disease must be present, with at least one lesion designated as an indicator lesion; a lesion pictured by ultrasound or computerized axial tomography is measurable if at least two perpendicular diameters can be measured and the procedure can be repeated serially. Malignant hepatomegaly is acceptable as an indicator lesion only when the liver contains biopsy-proven cancer and extends at least 5 cm below the costal margin. An ECOG performance status of 2 or better and a life expectancy of at least 60 days are required. Patients must meet the following hematologic, renal, and hepatic criteria (measured within 14 days prior to entry): WBC at least 4,000, platelets at least 100,000, granulocytes at least 2,000, and hemoglobin at least 10 g/dl (transfusion is allowed); creatinine no greater than 1.7 mg/dl; and bilirubin no greater than 1.7 and SGPT or SGOT each no greater than 2.0 times the upper limit of normal. If bilirubin, SGPT, or SGOT exceeds the upper limit of normal, the liver must be evaluated radiographically (e.g., by CT scan) prior to therapy. Aside from skin cancer, there may have been no other malignancy within the past 5 years; weight loss exceeding 15% of body weight within the past 2 months is not allowed. Current acute or chronic infection or brain metastases exclude. Patients must not be pregnant and must be physically incapable of becoming pregnant or be currently using adequate contraception, with a firm commitment to continue. Expected Enrollment Up to 25 patients may be accrued in order to obtain 15 evaluable patients; if at least one objective response is seen in the first 15 evaluable patients, accrual will continue until 15 additional evaluable patients are entered, to a maximum of 40 patients total. An estimated 18 to 24 months will be required for accrual. Outline Nonrandomized study. Single-agent Chemotherapy. Amonafide, NSC-308847.Published Results Rosen F, Kies M, Wade J, et al.: Phase II study of amonafide in the treatment of patients with advanced squamous cell carcinoma of the head and neck: an Illinois Cancer Center trial. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-914, 283, 1993. Trial Lead Organizations Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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. |
![]() |
![]() |
![]() |
![]() |
NCI Home |
Images Version |
Contact Us |
Policies |
Accessibility |
Viewing Files |
FOIA |
Site Help |
Site Map
|
![]() A Service of the National Cancer Institute |
![]() |
![]() |