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Phase II Study of LY186641 (a Sulfonylurea) in Patients with Advanced and/or Metastatic Carcinoma of the Pancreas (Summary Last Modified 03/90)
Basic Trial Information
Objectives I. Determine the objective response rate, duration of remission, and progression-free interval induced by oral LY186641 administered on a daily x 5 schedule over 3 consecutive weeks with re-treatment at 4-week intervals in patients with advanced and/or metastatic carcinoma of the pancreas who have received no prior cytotoxic therapy (other than that administered in conjunction with radiotherapy and discontinued at completion of radiotherapy). II. Characterize the toxicity of LY186641 in this patient population. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients between the ages of 19 and 75 years with histologic diagnosis of advanced and/or metastatic adenocarcinoma of the pancreas. Patients may have received no prior biologic therapy and no prior cytotoxic therapy other than that administered in conjunction with radiotherapy and discontinued following completion of the radiotherapy; at least 3 weeks must have elapsed since any prior radiotherapy. Prior therapy with LY186641 is not permitted. Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, scan, or physical exam, is required; measurable lesions defined by CT, MRI, or ultrasound must be a minimum of 2 x 2 cm, but those defined by chest x-ray or physical exam may be 1 x 1 cm. Patients who have had prior radiotherapy must have a measurable lesion outside the radiation port. Patients with a history of hypersensitivity to sulfa compounds are ineligible, as are those with known red blood cell hemolytic disorder or evidence of hemolysis or with other hemoglobinopathies; a normal sickledex test is required. There must have been no RBC transfusions for at least 3 weeks prior to entry; hematocrit must be at least 30%, hemoglobin at least 10 g/dl, and methemoglobin no more than 2% of total hemoglobin. A Zubrod performance status of 0 or 1 and a life expectancy of at least 12 weeks are required, as are the following laboratory parameters: normal glucose-6-phosphate dehydrogenase screen; total bilirubin no more than 1.5 mg/dl and/or SGOT no more than 3 times normal; PT and/or PTT no more than 1.5 times normal; creatinine no more than 1.5 mg/dl; calcium no more than 10.5 mg/dl; and WBC at least 3,500 and platelets at least 100,000. The following conditions exclude: significantly abnormal EKG or recent history of significant heart disease; significant documented coronary artery disease (e.g., EKG or active angina), severe pulmonary disease, or significant peripheral vascular disease; active infection; and diabetes that is not well controlled with oral hypoglycemic agents or insulin. Patients with leukemia and/or a second primary carcinoma within the past 5 years, other than resected basal cell carcinoma or curatively resected Stage I or less cervical cancer, are ineligible. Women must be postmenopausal by reason of surgery, radiation, or normal menopause or must use an approved method of contraception (IUD, birth control pills, or barrier device); pregnant or breast-feeding women are ineligible. Geographic proximity permitting adequate follow-up is required. Expected Enrollment Initially 15 patients will be entered in this multicenter study. If no responses or 5 or more responses are seen, accrual will cease; if 1-4 responses are seen, 10 additional patients will be entered. If 4 or 5 responses are seen among all 25 patients, 10 additional patients will be entered. In addition, if more than 4 of the first 15 patients, more than 7 of 25 patients, or more than 9 of 35 patients discontinue therapy because of undue toxicity before completing the on-drug portion of the second course, the study will be stopped. It is anticipated that accrual will be completed within 12-18 months. Outline Nonrandomized study. Single-agent Chemotherapy. N-(5-Indanylsulfonyl)-N'-4-(chlorophenyl)-urea, LY186641. Trial Lead Organizations UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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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