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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00397787 |
RATIONALE: Sunitinib may stop the growth of pancreatic cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic pancreatic cancer that progressed after first-line therapy with gemcitabine.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: sunitinib malate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | A Phase II Study of Sunitinib Malate (SU11248, NSC #736511, IND #74,019) in Patients With Previously Treated Pancreatic Adenocarcinoma With Measurable Metastatic Disease Following Progression on Front-Line Gemcitabine-Based Therapy |
Estimated Enrollment: | 64 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, nonrandomized study.
Patients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed every 3 months until 2 years from study entry.
PROJECTED ACCRUAL: A total of 64 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
Must have evidence of disease progression after receiving 1 of the following prior first-line therapies:
One gemcitabine-containing chemoradiotherapy regimen for inoperable locally advanced pancreatic cancer
One adjuvant chemotherapy regimen or chemoradiotherapy containing gemcitabine
PATIENT CHARACTERISTICS:
No cardiac disease within the past 12 months, including any of the following:
No history of any of the following diseases within the past 6 months:
No currently active second malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
No prior therapy with any other antiangiogenic agent, including any of the following:
More than 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following:
More than 12 days since prior and no concurrent CYP3A4 inducers, including any of the following:
No concurrent agents with proarrhythmic potential, including any of the following:
No concurrent therapeutic doses of warfarin-derived anticoagulants
Study Chair: | Eileen O'Reilly, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000511035, CALGB-80603 |
Study First Received: | November 9, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00397787 |
Health Authority: | United States: Food and Drug Administration |
adenocarcinoma of the pancreas recurrent pancreatic cancer stage IV pancreatic cancer |
Digestive System Neoplasms Pancreatic Neoplasms Disease Progression Endocrine System Diseases Pancrelipase Recurrence Digestive System Diseases Sunitinib |
Neoplasm Metastasis 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 Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |