NCT00804310

Lapatinib and Ixabepilone in Treating Patients With Advanced Solid Tumors

Phase I Study of Lapatinib (GW572016) in Combination With Weekly Ixabepilone (BMS 247550) in Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * To evaluate the safety and feasibility of lapatinib ditosylate in combination with ixabepilone in patients with advanced solid tumors. Secondary * 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	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.
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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-08-01
• Completion: 2011-09-01
• First posted: 2008-12-08
• Last updated: 2012-03-28

Locations

4 sites across 1 country: United States