Capecitabine, Cetuximab, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Removed By Surgery

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Herbert Hurwitz
Study ID
NCT00290615
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — BIOLOGICAL
  • cetuximab — BIOLOGICAL
  • capecitabine — DRUG
  • oxaliplatin — DRUG

Study Details

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine together with cetuximab, oxaliplatin, and bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine together with cetuximab, oxaliplatin, and bevacizumab works in treating patients with metastatic or recurrent colorectal cancer that cannot be removed by surgery.

Key Dates

First listed
Feb 13, 2006
Start date
Jan 31, 2006
Status verified
Mar 2013
Primary completion
Jan 31, 2009
Completion
Jan 31, 2011

Study Design

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

Arms

  • Experimental: Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab
    Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle. Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle. Cycles are 21 days.

Primary Outcome Measure

Response Rate (Percentage of Participants With Partial or Complete Response) [ Time Frame: After all subjects were evaluated for restaging which occured every 9 weeks from drug initiation until disease progression, assesed up to 24 months. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Duke Comprehensive Cancer CenterDurhamNorth Carolina27710-
Wake Forest University Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-1096-

Find similar trials in Durham, NC

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Duke Comprehensive Cancer Center· Durham, NCWake Forest University Comprehensive Cancer Center· Winston-Salem, NC

Related Studies