A Dose Escalation Phase II Study of Sunitinib Plus Erlotinib in Advanced Renal Carcinoma
- Determine the maximum tolerated dose of erlotinib hydrochloride when administered with
sunitinib malate in patients with unresectable or metastatic renal cell carcinoma.
- Determine the 8-month progression-free survival of patients treated with this regimen.
- Determine the safety of sunitinib malate and erlotinib hydrochloride in these patients.
- Determine the duration of response in these patients.
- Determine the proportion of patients whose best overall response is complete response,
partial response, stable disease, or progressive disease.
- Determine the overall survival of patients treated with this regimen.
- Determine the maximum percent reduction in tumor measurement in patients treated with
- Collect blood and tissue from these patients for future correlative studies.
OUTLINE: This is an open-label, multicenter, dose-escalation study of erlotinib
Patients receive oral sunitinib malate once daily on days 1-28 and oral erlotinib
hydrochloride once daily on days 1-42. Treatment repeats every 6 weeks in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of
patients experience dose-limiting toxicity. Once the MTD is determined, patients are treated
with erlotinib hydrochloride at the MTD and sunitinib malate.
Patients undergo blood and tumor specimen collection periodically during study for future
PROJECTED ACCRUAL: A total of 49 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose of Erlotinib Hydrochloride When Used in Combination With Sunitinib.
The MTD is defined as the dose that produces dose limiting toxicity (DLT) in 33% of the patients.
Evaluated at each dose level for the duration of the study.
Christopher W. Ryan, MD
OHSU Knight Cancer Institute
United States: Federal Government
|Providence Cancer Center at Providence Portland Medical Center||Portland, Oregon 97213-2967|
|OHSU Knight Cancer Institute||Portland, Oregon 97239|
|University of Southern California||Los Angeles, California 90033|
|Salem Hospital||Salem, Oregon 97309|