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

PHASE1CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

March 31, 2005

Primary Completion Date

January 31, 2011

Study Completion Date

January 31, 2011

Conditions
Colorectal Cancer
Interventions
BIOLOGICAL

bevacizumab

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.

DRUG

erlotinib hydrochloride

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.

DRUG

fluorouracil

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.

DRUG

leucovorin calcium

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.

DRUG

oxaliplatin

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.

Trial Locations (3)

44109

MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland

44122

UHHS Chagrin Highlands Medical Center, Cleveland

44106-5065

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Case Comprehensive Cancer Center

OTHER

NCT00118261 - Erlotinib, Modified FOLFOX6, and Bevacizumab as First-Line Therapy Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter