Lapatinib and Doxorubicin Hydrochloride Liposome in Treating Patients With Metastatic Breast Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT00316875
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • lapatinib ditosylate — DRUG
    1500 mg orally daily for as long as patients remain on trial (up to 8 cycles).
  • Doxil — DRUG
    Administered intravenously (IV) every 4 weeks in a dose-escalating fashion according to a set schedule

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 doxorubicin hydrochloride liposome 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 doxorubicin hydrochloride liposome may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of doxorubicin hydrochloride liposome when given together with lapatinib in treating patients with metastatic breast cancer.

Key Dates

Start date
May 31, 2006
Status verified
Nov 2013
Primary completion
Aug 31, 2011
Completion
Aug 31, 2011

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib Ditosylate and Doxil

Primary Outcome Measure

Cardiac safety [ Time Frame: Throughout treatment and up to 30 days post-treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicagoIllinois60611-3013-

Find similar trials in Chicago, IL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Robert H. Lurie Comprehensive Cancer Center at Northwestern University· Chicago, IL

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