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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: | NCT00331682 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel and flavopiridol, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Flavopiridol may also help docetaxel work better by making tumor cells more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving docetaxel followed by flavopiridol works in treating patients with refractory metastatic pancreatic cancer.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: alvocidib Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | An Open-Label, Non-Randomized Phase II Study of Flavopiridol in Combination With Docetaxel in Refractory, Metastatic Pancreatic Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | March 2006 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a non-randomized, open-label, prospective study.
Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
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
Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
Documented progression with measurable metastatic disease including any 1 of the following criteria:
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to any of the following:
Cardiac arrhythmia or myocardial infarction within the past 6 months
PRIOR CONCURRENT THERAPY:
No concurrent commonly used vitamins, antioxidants, or herbal preparations or supplements
United States, New York | |
Memorial Sloan - Kettering Cancer Center | |
New York, New York, United States, 10021-0009 |
Study Chair: | Eileen O'Reilly, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000472413, MSKCC-05136, NCI-6366 |
Study First Received: | May 30, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00331682 |
Health Authority: | United States: Food and Drug Administration |
recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancrelipase Recurrence Docetaxel Flavopiridol |
Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Enzyme Inhibitors Growth Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |