Erlotinib and Everolimus in Treating Patients With Metastatic Breast Cancer

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT00574366
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • erlotinib — DRUG
    Levels: * 1 Erlotinib 50 mg/d * 2 Erlotinib 50 mg/d * 1 Erlotinib 100 mg/d * 2 Erlotinib 100 mg/d * 3 Erlotinib 150 mg/d * 4 Erlotinib 150 mg/d
  • RAD001 — DRUG
    Levels minus 1: RAD001 2.5 mg/d minus 2: RAD001 2.5 every other day 1. RAD001 2.5 mg per day 2. RAD001 5 mg per day 3. RAD001 10 mg per day 4. RAD001 10 mg per day

Study Details

RATIONALE: Erlotinib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib together with everolimus may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving erlotinib together with everolimus and to see how well it works in treating patients with metastatic breast cancer.

Key Dates

First listed
Dec 17, 2007
Start date
Dec 31, 2005
Status verified
May 2016
Primary completion
Jan 31, 2009
Completion
Feb 28, 2009

Study Design

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

Arms

  • Experimental: Erlotinib/RAD001 Ph I
    Tarceva (OSI-774; erlotinib) Everolimus (RAD001) Study did not progress to Phase II: Experimental: Erlotinib/RAD001 Phase II Maximum tolerated dose of erlotinib (Tarceva,OSI-774) and RAD001 (Everolimus)

Primary Outcome Measure

To determine the maximum tolerated dose (MTD) of RAD001 given in combination with erlotinib (Phase I) [ Time Frame: at 4 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-6838-
Vanderbilt-Ingram Cancer Center - Cool SpringsNashvilleTennessee37064-
Vanderbilt-Ingram Cancer Center at FranklinNashvilleTennessee37064-

Find similar trials in Nashville, TN

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Vanderbilt-Ingram Cancer Center· Nashville, TNVanderbilt-Ingram Cancer Center - Cool Springs· Nashville, TNVanderbilt-Ingram Cancer Center at Franklin· Nashville, TN

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