Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 19 to 75 UNMC-38089 NCI-V89-0270

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 Contact Information

Trial Lead Organizations

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Margaret Tempero, MD, Protocol chair		Ph: 415-885-3846; 800-888-8664 Email: mtempero@medicine.ucsf.edu