Kidney Cancer Clinical Trial
Official title:
A Dose Escalation Phase II Study of Sunitinib Plus Erlotinib in Advanced Renal Carcinoma
RATIONALE: Sunitinib and erlotinib may stop the growth of tumor cell by blocking some of the
enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib
together with erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying the best dose of erlotinib when given together with
sunitinib and to see how well they work in treating patients with unresectable or metastatic
kidney cancer.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
this regimen.
- Collect blood and tissue from these patients for future correlative studies.
OUTLINE: This is an open-label, multicenter, dose-escalation study of erlotinib
hydrochloride.
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
correlative studies.
PROJECTED ACCRUAL: A total of 49 patients will be accrued for this study.
;
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