Lapatinib and Ixabepilone in Treating Patients With Advanced Solid Tumors (UCDCC#207)
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|ClinicalTrials.gov Identifier: NCT00804310|
Recruitment Status : Terminated (Lack of funding)
First Posted : December 8, 2008
Last Update Posted : March 28, 2012
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 or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: ixabepilone Drug: lapatinib ditosylate||Phase 1|
- To evaluate the safety and feasibility of lapatinib ditosylate in combination with ixabepilone in patients with advanced solid tumors.
- To determine the maximum-tolerated dose of this regimen in these patients.
- To assess, preliminarily, the efficacy of this regimen in these patients.
- To perform laboratory correlative studies on tissue and blood specimens from these patients to investigate potential predictors of response.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Lapatinib (GW572016) in Combination With Weekly Ixabepilone (BMS 247550) in Advanced Solid Tumors|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||September 2011|
|Experimental: Lapatinib and Ixabepilone||
This intravenous treatment will be performed on an outpatient basis. Ixabepilone (15 - 20mg/m2) will be given weekly for 3 weeks, then one week off, every 28 days (4 weeks). The study doctor will decide how long to keep the participant on this treatment based on how the participant is tolerating the drug and how it is affecting the tumor.
Other Name: Ixempra
Drug: lapatinib ditosylate
Lapatinib (1000-1500 mg) will be administered orally on a daily basis. The study doctor will decide how long to keep the participant on this treatment based on how the participant is tolerating the drug and how it is affecting the tumor.
Other Name: Tykerb/Tyverb
- Safety and Toxicity [ Time Frame: Toxicity will be assessed at the beginning of every cycle and on day 8 and 15 of every cycle for at least eight weeks (2 cycles). Maximum of 6 cycles. ]Assessed by NCI CTCAE v 3.0
- Maximum tolerated dose (MTD) [ Time Frame: One cycle (4 weeks) ]
- Preliminary efficacy [ Time Frame: One year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804310
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90089-9181|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|United States, Louisiana|
|Feist-Weiller Cancer Center at Louisiana State University Health Sciences|
|Shreveport, Louisiana, United States, 71130-3932|
|Principal Investigator:||Helen K. Chew, MD||University of California, Davis|