Bendamustine and Erlotinib in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Breast Cancer

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT00834678
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bendamustine — DRUG
    100 or 120 mg/m2 IV on days 1 and 2
  • erlotinib — DRUG
    100 or 150 mg po on days 5 - 21 of each 28 day cycle
  • Maintenance erlotinib — DRUG
    150 mg po daily (days 1 - 28 of 28 day cycle)

Study Details

RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving bendamustine together with erlotinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving bendamustine together with erlotinib in treating patients with stage IIIB, stage IIIC, or stage IV breast cancer.

Key Dates

First listed
Feb 3, 2009
Start date
Apr 30, 2009
Status verified
Mar 2018
Primary completion
Aug 31, 2013
Completion
Sep 30, 2014

Study Design

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

Arms

  • Experimental: Bendamustine and Erlotinib
    Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 - 21 of each 28 day cycle.

Primary Outcome Measure

Maximum-tolerated Dose of Bendamustine Hydrochloride (Phase I) [ Time Frame: Up to two years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Medical CenterColumbusOhio43210-

Find similar trials in Columbus, OH

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Ohio State University Medical Center· Columbus, OH

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