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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00462553 |
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. 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. Giving sunitinib together with gemcitabine may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of sunitinib and gemcitabine in treating patients with pancreatic cancer or other solid tumors.
Condition | Intervention | Phase |
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Pancreatic Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: gemcitabine hydrochloride Drug: sunitinib malate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Sunitinib Malate and Standard Infusion Gemcitabine in Solid Tumors |
Estimated Enrollment: | 37 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
OUTLINE: This is a dose-escalation study.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 OR on days 1, 8, and 15. Patients also receive oral sunitinib malate once daily on days 1-21 OR days 1-28. Treatment repeats every 21 days OR every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and sunitinib malate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 patients may be treated at the recommended phase II dose (RPTD), which is generally the dose level below the maximally administered dose.
After completion of study treatment, patients are followed for 30 days and then periodically thereafter.
PROJECTED ACCRUAL: A total of 37 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 other solid tumor
PATIENT CHARACTERISTICS:
No history of any of the following within the past 6 months:
No NYHA class III or IV heart disease
No condition that impairs the ability to swallow and retain sunitinib malate tablets, including any of the following:
PRIOR CONCURRENT THERAPY:
No prior sunitinib malate or other therapy directed against VEGF, 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 treatment on another clinical trial
United States, Ohio | |
Case Comprehensive Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44106-5065 | |
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
Geauga Regional Hospital | Recruiting |
Cleveland, Ohio, United States, 44024 | |
Contact: Joanna M Brell 216-844-1676 | |
Lake/University Ireland Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44060 | |
Contact: Joanna M Brell 216-844-1676 | |
Mercy Cancer Center at Mercy Medical Center | Recruiting |
Cleveland, Ohio, United States, 44708 | |
Contact: Joanna M Brell 216-844-1676 | |
University Suburban Health Center | Recruiting |
Cleveland, Ohio, United States, 44121 | |
Contact: Joanna M Brell 216-844-1676 | |
UHHS Chagrin Highlands Medical Center | Recruiting |
Cleveland, Ohio, United States, 44122 | |
Contact: Joanna M Brell 216-844-1676 | |
UHHS Westlake Medical Center | Recruiting |
Cleveland, Ohio, United States, 44145 | |
Contact: Joanna M Brell 216-844-1676 | |
Southwest General Health Center | Recruiting |
Cleveland, Ohio, United States, 44130 | |
Contact: Joanna M Brell 216-844-1676 |
Study Chair: | Joanna M. Brell, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000539459, CASE-3206 |
Study First Received: | April 18, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00462553 |
Health Authority: | Unspecified |
recurrent pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer adenocarcinoma of the pancreas unspecified adult solid tumor, protocol specific |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancrelipase Recurrence Digestive System Diseases Sunitinib |
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 |