Clinical trial NCT00425386
Conditions: Kidney Cancer
Keywords: stage III renal cell cancer stage IV renal cell cancer clear cell renal cell carcinoma recurrent renal cell cancer
Sponsor: OHSU Knight Cancer Institute
Start date: 2006-08-01; Completion date: 2014-03-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Drug: erlotinib hydrochloride Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;

1. 100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
2. 150 mg/day, continuous daily

Drug: sunitinib malate Will be administered at 50 mg daily, 4 weeks on, 2 weeks off
Interventions: intervention 1: erlotinib hydrochloride intervention 2: sunitinib malate intervention 3: biopsy
Intervention descriptions: intervention 1: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;

1. 100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
2. 150 mg/day, continuous daily intervention 2: Will be administered at 50 mg daily, 4 weeks on, 2 weeks off intervention 3: Paraffin block (or unstained slides) of the primary tumor and/or metastatic lesions (as available) and a plasma sample for future correlative studies will be collected. A paraffin block (or at least 10 unstained slides, each of 10 micromillimeter thickness) from the original paraffin-embedded biopsy material taken at the diagnosis will be stored at 4 degrees Celsius.

Protocol documents: