A Phase IB Study in Patients With Metastatic Colorectal Cancer to Evaluate Pharmacodynamic Effects of Erlotinib and Safety and Efficacy of Erlotinib in Combination With Modified FOLFOX6 (mFOLFOX6) and Bevacizumab
- Determine the toxicity of erlotinib, mFOLFOX6, and bevacizumab in patients with
metastatic colorectal cancer.
- Determine the efficacy of this regimen in these patients.
- Determine the feasibility of escalating the dose of erlotinib in order to maximize the
likelihood of developing a grade 2 skin rash in select patients.
OUTLINE: This is a multicenter study.
- Single-agent erlotinib: Patients receive oral erlotinib once daily on days 1-14 (course
- Erlotinib, modified FOLFOX6, and bevacizumab chemotherapy: Patients receive oral
erlotinib* once daily on days 1-14, oxaliplatin IV over 2 hours and leucovorin calcium
IV over 2 hours on day 1, and fluorouracil IV continuously over 46 hours on days 1 and
2 in course 2. Beginning in course 3, patients also receive bevacizumab IV over 30
minutes. Courses repeat every 14 days in the absence of disease progression or
NOTE: Patients who do not develop grade 2 toxicity after the first 3 courses (6 weeks) will
have their erlotinib dose escalated.
PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients that develop study drug related toxicity
Dose-limiting toxicities will be tracked in the first three cycles. The occurrence of DLT in 2 of the first 6 patients, 3 of the first 9 patients, or 4 of the first 12 patients (whichever occurs soonest)will require that subsequent patients are enrolled to the study at 100 mg erlotinib daily.
3 courses (6 weeks)
Smitha Krishnamurthi, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|MetroHealth Cancer Care Center at MetroHealth Medical Center||Cleveland, Ohio 44109|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|UHHS Chagrin Highlands Medical Center||Orange Villager, Ohio 44122|