Erlotinib, Modified FOLFOX6, and Bevacizumab as First-Line Therapy Metastatic Colorectal Cancer

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT00118261
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — BIOLOGICAL
    Beginning in course 3, patients also receive bevacizumab IV over 30 minutes. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
  • erlotinib hydrochloride — DRUG
    Courses 1-3: oral erlotinib once daily on days 1-14. Patients who do not develop grade 2 toxicity after the first 3 courses (6 weeks) will have their erlotinib dose escalated. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
  • fluorouracil — DRUG
    Starting with course 2: fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
  • leucovorin calcium — DRUG
    Starting with course 2: Leucovorin calcium IV over 2 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
  • oxaliplatin — DRUG
    Starting with course 2: oxaliplatin IV over 2 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Study Details

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as 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. Erlotinib may help chemotherapy work better by making tumor cells more sensitive to the drugs. Giving erlotinib together with combination chemotherapy and bevacizumab may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given together with combination chemotherapy and bevacizumab as first-line therapy in treating patients with metastatic colorectal cancer.

Key Dates

First listed
Jul 11, 2005
Start date
Mar 31, 2005
Status verified
Aug 2012
Primary completion
Jan 31, 2011
Completion
Jan 31, 2011

Study Design

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

Arms

  • Experimental: Erlotinib, modified FOLFOX6, and bevacizumab

Primary Outcome Measure

Number of patients that develop study drug related toxicity [ Time Frame: 3 courses (6 weeks) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106-5065-
MetroHealth Cancer Care Center at MetroHealth Medical CenterClevelandOhio44109-
UHHS Chagrin Highlands Medical CenterClevelandOhio44122-

Find similar trials in Cleveland, OH

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OHMetroHealth Cancer Care Center at MetroHealth Medical Center· Cleveland, OHUHHS Chagrin Highlands Medical Center· Cleveland, OH

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