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Phase II Study of UCN-01 in Combination With Fluorouracil in Advanced Pancreatic Cancer
RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with fluorouracil in treating patients who have metastatic pancreatic cancer that has not responded to treatment with gemcitabine.
OBJECTIVES: * Determine the response rate, time to progression, and overall survival of patients with gemcitabine-refractory metastatic pancreatic cancer treated with UCN-01 and fluorouracil. * Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive fluorouracil IV over 24 hours on days 1, 8, 15, and 22. Patients also receive UCN-01 IV continuously over 72 hours (course 1 only) beginning on day 2. In subsequent courses, UCN-01 is infused over 36 hours. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 3-13 months.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Start Date
July 1, 2002
Completion Date
September 1, 2004
Last Updated
June 24, 2013
7-hydroxystaurosporine
DRUG
fluorouracil
DRUG
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NCT04550494
NCT05053971
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