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Sponsors and Collaborators: |
University of California, Davis National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00804310 |
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving lapatinib together with ixabepilone may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib given together with ixabepilone in treating patients with advanced solid tumors.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: ixabepilone Drug: lapatinib ditosylate Genetic: DNA analysis Genetic: gene expression analysis Genetic: mutation analysis Genetic: nucleic acid sequencing Genetic: polymerase chain reaction Genetic: proteomic profiling Genetic: reverse transcriptase-polymerase chain reaction Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacogenomic studies |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Lapatinib (GW572016) in Combination With Weekly Ixabepilone (BMS 247550) in Advanced Solid Tumors |
Estimated Enrollment: | 34 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive oral lapatinib ditosylate once daily on days 1-28 and ixabepilone IV on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Archival tumor tissue samples are collected for EGFR/HER2 pathway analyses via immunohistochemistry, mRNA analysis via RT-PCR, EGFR mutation analyses, Kras and braf mutation analysis via sequencing, and RAS mutations via PCR and sequencing. Blood samples are also collected periodically for tumor DNA and proteomics, acetylated alpha-tubulin analysis, EGFR-HER2 pathway genotypes, and pharmacogenomics.
After completion of study therapy, patients are followed for 30 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed advanced solid tumors meeting one of the following criteria:
Measurable or evaluable disease
Patients with asymptomatic previously treated (e.g., surgical resection or radiotherapy) brain metastasis are eligible provided they are neurologically stable and have been off steroids for at least 2 weeks
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, the following:
PRIOR CONCURRENT THERAPY:
Medications classified as CYP3A4 inducers or inhibitors must meet the following criteria:
At least 7 days since prior and no concurrent:
Gastrointestinal (i.e., cimetidine, aprepitant)
At least 14 days since prior and no concurrent:
Responsible Party: | University of California Davis Cancer Center ( Helen K. Chew ) |
Study ID Numbers: | CDR0000626165, UCD-207, UCDCC-207, 200816384-1 |
Study First Received: | December 5, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00804310 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |
Epothilones Tubulin Modulators Lapatinib Antimitotic Agents Protein Kinase Inhibitors |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Epothilones Mitosis Modulators Tubulin Modulators |
Enzyme Inhibitors Lapatinib Antimitotic Agents Protein Kinase Inhibitors Pharmacologic Actions |