BAY 43-9006 in Previously Untreated Patients With Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00533585
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • BAY 43-9006 — DRUG
    Starting Dose of 200 mg orally twice a day on Day 3 through Day 19 of Cycle 1 and Days 2 through 19 of Cycle 2 and remaining cycles. Cycle is 21 days.
  • Paclitaxel — DRUG
    200 mg/m\^2 By Vein Over 3 Hours on Day 1.
  • Carboplatin — DRUG
    Area under curve (AUC) 6 By Vein Over 30 Minutes on Day 1.
  • Bevacizumab — DRUG
    Starting Dose of 5 mg/kg By Vein Over 90 minutes on Day 1.

Study Details

The goal of this study is to find the highest tolerable dose of BAY 43-9006 (sorafenib) and bevacizumab that can be given with paclitaxel and carboplatin in patients with non-small cell lung cancer (NSCLC). The safety and effectiveness of this drug combination will also be studied.

Key Dates

First listed
Sep 21, 2007
Start date
May 31, 2006
Status verified
Feb 2016
Primary completion
Jan 31, 2016
Completion
Jan 31, 2016

Study Design

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

Arms

  • Experimental: BAY 43-9006 + Bevacizumab
    BAY 43-9006 (Sorafenib) + Bevacizumab + Paclitaxel + Carboplatin

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of BAY 43-9006 (sorafenib) and Bevacizumab in Combination with Carboplatin and Paclitaxel [ Time Frame: First day of every 21 day cycle ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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