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Sponsors and Collaborators: |
University of Miami Sylvester Comprehensive Cancer Center Bristol-Myers Squibb Pfizer |
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Information provided by: | University of Miami Sylvester Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00884676 |
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate 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.
PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone when given together with sunitinib malate in treating patients with progressive advanced solid tumors.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: Ixabepilone Drug: Sunitinib Other: Angiogenesis Biomarker Analysis Other: Pharmacokinetic Design |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Trial of Weekly and Every Three Weeks Ixabepilone and Sunitinib in Solid Tumor Patients |
Estimated Enrollment: | 36 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Administered intravenously. Dosage assigned by Phase I center as determined by dose-escalation schedule:
The following studies will be performed in the blood of study subjects:
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose escalation study of ixabepilone. Patients are assigned to 1 of 2 treatment groups.
After completion of study therapy, patients are followed at 30 days and every 3 months for 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Required laboratory values obtained <= 7 days prior to registration:
INR <= 1.5, unless the patient is on full dose warfarin or stable dose of LMW heparin with a therapeutic INR of > 1.5, <= 3.
EXCLUSION CRITERIA:
Invasive procedures defined as follows:
Any of the following, as this regimen may be harmful to a developing fetus or nursing child:
Patients with a history of serious ventricular arrhythmia (VT or VF >= 3 beats in a row) are also excluded.
Additionally, patients with ongoing atrial fibrillation are not eligible.
United States, Florida | |
University of Miami Sylvester Comprehensive Cancer Center | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: University of Miami Sylvester Comprehensive Cancer Center 866-574-5124 Sylvester@emergingmed.com | |
Sub-Investigator: Caio Max Rocha Lima, MD | |
Sub-Investigator: Luis Raez, MD | |
Sub-Investigator: Rakesh Singal, MD | |
Sub-Investigator: Pasquale Benedetto, MD | |
Sub-Investigator: Mark Pegram, MD | |
Sub-Investigator: Catherine Jones, MD | |
Sub-Investigator: Stefan Gluck, MD | |
Sub-Investigator: Alberto Montero, MD |
Study Chair: | Jaime R. Merchan, MD | University of Miami Sylvester Comprehensive Cancer Center |
Responsible Party: | University of Miami Sylvester Comprehensive Cancer Center ( Jaime Merchan MD ) |
Study ID Numbers: | EPROST-20080376, SCCC-2008001, BMS-SCCC-2008001 |
Study First Received: | April 18, 2009 |
Last Updated: | June 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00884676 History of Changes |
Health Authority: | United States: Food and Drug Administration |
unspecified adult solid tumor, protocol specific |
Lactams Epothilone B Sunitinib Epothilones |
Tubulin Modulators Antimitotic Agents Angiogenesis Inhibitors |
Epothilone B Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Epothilones Growth Substances Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents |
Angiogenesis Inhibitors Pharmacologic Actions Sunitinib Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents |