Bevacizumab in Multiple Phase I Combinations

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00543504
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancer

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    2.5 mg/kg By Vein Over 90 Minutes.
  • Sorafenib — DRUG
    200 mg By Mouth Daily for 28 Days
  • Erlotinib — DRUG
    50 mg By Mouth Daily for 28 Days.
  • Trastuzumab — DRUG
    Loading 2 mg/kg by vein then Maintenance 1 mg/kg by vein on Day 1
  • Lapatinib — DRUG
    250 mg By Mouth Daily for 21 Days.
  • Sunitinib — DRUG
    12.5 mg orally daily for 4 weeks, then 2 weeks off.
  • Cetuximab — DRUG
    Loading 100 mg/m² by vein and Maintenance 75 mg/m² by vein on Days 1, 8, 15, 22

Study Details

The goal of this clinical research study is to find the highest tolerable dose of Avastin™ that can be given in combination with 4 other study drug/drug combinations. It will be given with sunitinib, with sorafenib, with a combination of erlotinib and cetuximab, and with a combination of trastuzumab and lapatinib. The safety and effectiveness of these drug combinations will also be studied.

Key Dates

Start date
Oct 10, 2007
Status verified
Jan 2020
Primary completion
Apr 29, 2020
Completion
Apr 29, 2020

Study Design

Enrollment
343 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab + Sunitinib
    Arm 1: Bevacizumab starting dose 2.5 mg/kg intravenous (IV) over 90 minutes + Sunitinib 12.5 mg orally daily for 4 weeks, then 2 weeks off.
  • Experimental: Bevacizumab + Sorafenib
    Arm 2: Bevacizumab starting dose 2.5 mg/kg intravenous (IV) over 90 minutes + Sorafenib 200 mg by mouth daily for 28 Days
  • Experimental: Bevacizumab + Erlotinib + Cetuximab
    Arm 3: Bevacizumab starting dose 2.5 mg/kg intravenous (IV) over 90 minutes + Erlotinib 50 mg By Mouth Daily for 28 Days + Cetuximab loading dose 100 mg/m² IV and maintenance 75 mg/m² on Days 1, 8, 15, 22.
  • Experimental: Bevacizumab + Trastuzumab + Lapatinib
    Arm 4: Bevacizumab starting dose 2.5 mg/kg intravenous (IV) over 90 minutes + Trastuzumab loading dose 2 mg/kg IV then maintenance dose 1 mg/kg IV on Day 1 + Lapatinib 250 mg By Mouth Daily for 21 Days.

Primary Outcome Measure

Maximum Tolerable Dose (MTD) of Avastin in combination with 4 other study drug/drug combinations [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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