Bevacizumab and PEG-Interferon Alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors

Part of paid clinical trials in Houston, Texas.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00055809
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Gastrointestinal Carcinoid Tumor
  • Recurrent Gastrointestinal Carcinoid Tumor
  • Regional Gastrointestinal Carcinoid Tumor

Eligibility Criteria

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

Interventions

  • PEG-interferon alfa-2b — BIOLOGICAL
    Given SC
  • bevacizumab — BIOLOGICAL
    Given IV
  • laboratory biomarker analysis — OTHER
    Optional correlative studies

Study Details

This randomized phase II trial is to see if combining bevacizumab with PEG-interferon alfa-2b works in treating patients who have metastatic or unresectable carcinoid tumors. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. PEG-interferon alfa-2b may stop the growth of cancer by stopping blood flow to the tumor. Combining bevacizumab with PEG-interferon alfa-2b may kill more cancer cells

Key Dates

First listed
Mar 7, 2003
Start date
Jan 31, 2003
Status verified
Jan 2013
Primary completion
Jun 30, 2007

Study Design

Enrollment
44 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (bevacizumab)
    Patients receive bevacizumab IV on day 1.
  • Experimental: Arm II (PEG-interferon alfa-2b)
    Patients receive PEG-interferon alfa-2b SC on days 1, 8, and 15.

Primary Outcome Measure

Tumor response rate (CR + PR) as measured by RECIST criteria [ Time Frame: Up to 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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