Phase II Trial of Lapatinib & Capecitabine for Patients With Refractory Advanced Colorectal Adenocarcinoma

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT00574171
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • lapatinib — DRUG
    1250mg by mouth daily one hour before or after breakfast on a continuous basis.
  • Capecitabine — DRUG
    2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.

Study Details

The purpose of this study is to find out how effective this combination is as a second line treatment for colorectal cancer that has spread from one part of the body to another (metastasized) or has not metastasized but is considered inoperable (unable to be removed by surgery). The side effects and survival experienced by subjects receiving these drugs will also be evaluated. This is a phase II research study.

Key Dates

Start date
Sep 30, 2007
Status verified
Feb 2016
Primary completion
Aug 31, 2009
Completion
Aug 31, 2009

Study Design

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

Arms

  • Experimental: 1

Primary Outcome Measure

Response Rate of Lapatinib/Capecitabine. [ Time Frame: duration of study; on average 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadisonWisconsin53792-

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By research site
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center· Madison, WI

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