Lapatinib and Ixabepilone in Treating Patients With Advanced Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
University of California, Davis
Study ID
NCT00804310
Phase
PHASE1
Status
Terminated

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ixabepilone — DRUG
    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.
  • lapatinib ditosylate — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 31, 2009
Status verified
Mar 2012
Primary completion
Aug 31, 2011
Completion
Sep 30, 2011

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib and Ixabepilone

Primary Outcome Measure

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. ]

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-3000-
USC/Norris Comprehensive Cancer Center and HospitalLos AngelesCalifornia90089-9181-
University of California Davis Cancer CenterSacramentoCalifornia95817-
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveportLouisiana71130-3932-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUSC/Norris Comprehensive Cancer Center and Hospital· Los Angeles, CAUniversity of California Davis Cancer Center· Sacramento, CAFeist-Weiller Cancer Center at Louisiana State University Health Sciences· Shreveport, LA

Related Studies