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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00161213 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works as first-line therapy in treating patients with locally advanced or metastatic pancreatic cancer.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: gemcitabine hydrochloride Drug: imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled |
Official Title: | Phase II Study of Imatinib Mesylate and Gemcitabine for First-Line Treatment of Metastatic Pancreatic Cancer |
Estimated Enrollment: | 42 |
Study Start Date: | February 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, nonrandomized, open-label, uncontrolled study.
Patients receive gemcitabine hydrochloride IV over 120 minutes on days 3 and 10 and oral imatinib mesylate on days 1-5 and 8-12. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 42 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 pancreatic adenocarcinoma or poorly differentiated carcinoma (originating in the pancreas)
Must have measurable or evaluable disease as defined by RECIST criteria
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior radiotherapy and recovered
No concurrent therapeutic warfarin
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611-3013 | |
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu | |
United States, New Jersey | |
Cancer Institute of New Jersey at Hamilton | Recruiting |
Hamilton, New Jersey, United States, 08690 | |
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Ham 609-631-6946 | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
New Brunswick, New Jersey, United States, 08903 | |
Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
Saint Peter's University Hospital | Recruiting |
New Brunswick, New Jersey, United States, 08903 | |
Contact: Contact Person 732-745-8600 | |
Jersey Shore Cancer Center at Jersey Shore University Medical Center | Recruiting |
Neptune, New Jersey, United States, 07754 | |
Contact: Contact Person 732-776-4240 | |
CentraState Medical Center | Recruiting |
Freehold, New Jersey, United States, 07728 | |
Contact: Contact Person 732-431-2000 |
Principal Investigator: | Elizabeth A. Poplin, MD | Cancer Institute of New Jersey |
Study ID Numbers: | CDR0000539409, CINJ-070501, CINJ-5324, CINJ-NJ1205 |
Study First Received: | September 8, 2005 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00161213 |
Health Authority: | Unspecified |
recurrent pancreatic cancer stage IV pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas stage II pancreatic cancer |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancrelipase Recurrence Imatinib Digestive System Diseases |
Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Protein Kinase Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |