A Randomized Phase II Study of Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Irinotecan as Second Line Therapy in Patients With Metastatic Colorectal Cancer
- Determine the response rate in patients with metastatic colorectal cancer treated with
erlotinib hydrochloride and panitumumab with versus without irinotecan hydrochloride as
second-line therapy .
- Determine time to disease progression and time to treatment failure in patients treated
with these regimens.
- Determine the safety of these regimens in these patients.
- Determine the effect of these regimens on downstream targets of EGFR in skin rash
associated with pharmacologic EGFR inhibition (exploratory).
- Determine the association between KRAS mutations and response to EGFR inhibition
OUTLINE: This is a multicenter study. Patients are stratified according to wild-type Kras
tumors ( 6/6 UGT1A1 vs 6/7 UGT1A1), and are randomized to 1 of 2 treatment arms. Patients
with wild-type Kras tumor 7/7 UGT1A1 receive treatment in arm III.
- Arm I: Patients receive oral erlotinib hydrochloride once daily on days 1-14,
panitumumab IV over 30-90 minutes on day 1, and irinotecan hydrochloride IV over 90
minutes on day 1. Treatment repeats every 2 weeks in the absence of disease progression
or unacceptable toxicity.
- Arm II: Patients receive oral erlotinib hydrochloride once daily on days 1-14 and
panitumumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks in the
absence of disease progression or unacceptable toxicity. Upon disease progression,
patients receive irinotecan hydrochloride as in arm I.
- Arm III: Patients receive erlotinib hydrochloride and panitumumab as in arm II. Skin
biopsies and blood samples may be collected for further analysis.
After completion of study therapy, patients are followed every 6 weeks.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the tumor response rate
Tumor response rate will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression.
Every 8 weeks until disease progression
Al Benson, MD
United States: Food and Drug Administration
|Joliet Oncology-Hematology Associates, Ltd.||Flossmoor, Illinois 60422|
|Northwestern University, Northwestern Medical Faculty Foundation||Chicago, Illinois 60611-3013|
|Cancer Care & Hematology Specialists of Chicagoland||Niles, Illinois 60714|
|Hematology/Oncology Associates||Chicago, Illinois 60611|