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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00045747 |
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.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: 7-hydroxystaurosporine Drug: fluorouracil |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of UCN-01 in Combination With Fluorouracil in Advanced Pancreatic Cancer |
Study Start Date: | July 2002 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
At least 1 unidimensionally measurable metastatic lesion
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Gary K. Schwartz, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000257125, MSKCC-02049, NCI-5509 |
Study First Received: | September 6, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00045747 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the pancreas recurrent pancreatic cancer stage IV pancreatic cancer |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases 7-hydroxystaurosporine Pancrelipase Recurrence Digestive System Diseases |
Fluorouracil Staurosporine Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Endocrine Gland Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses |