Proton Therapy and Bevacizumab for Primary Liver Tumors

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00426829
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    10 mg/kg by vein every 14 days +/- 2 days, starting on day 1.
  • Proton Radiation Therapy — RADIATION
    3 Gy dose/fraction x 20 fractions.

Study Details

Primary Objectives: 1. To evaluate the safety of the treatment of patients with technically or medically inoperable hepatocellular carcinoma and cholangiocarcinoma with proton therapy and concurrent bevacizumab biotherapy. 2. To identify the maximum tolerated dose (MTD) using this combination. Secondary Objectives: 1. To evaluate local control rate within the radiation field, hepatic control rate outside the treatment field, time to radiographic progression and 2 year survival rate. 2. To analyze dose-volume characteristics that influence the development of radiation induced liver disease (RILD) and GI bleeds that may occur. 3. To assess quality of life during and after chemoradiation therapy.

Key Dates

First listed
Jan 25, 2007
Start date
May 31, 2007
Status verified
Jul 2012
Primary completion
Nov 30, 2009
Completion
Nov 30, 2009

Study Design

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

Arms

  • Experimental: Proton Therapy + Bevacizumab
    Proton Therapy + Bevacizumab

Primary Outcome Measure

Toxicity (during and within 1 month after completion of radiotherapy) [ Time Frame: 1 month +/- 1 week upon completion of concurrent chemoradiation ]

Locations (1)

FacilityCityStateZIPSite coordinators
U.T. M.D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
U.T. M.D. Anderson Cancer Center· Houston, TX

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