Sunitinib and Erlotinib in Treating Patients With Unresectable or Metastatic Kidney Cancer
- Conditions
- Kidney Cancer
- Interventions
- Registration Number
- NCT00425386
- Lead Sponsor
- OHSU Knight Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Erlotinib and Sunitinib erlotinib hydrochloride 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 Erlotinib and Sunitinib biopsy 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 Erlotinib and Sunitinib sunitinib malate 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
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib. Participants assessed for DLTs weekly during the first cycle of treatment and every 3 weeks in subsequent cycles until at least one DLT occurs in 33% or more of participants at that dose; participants assessed for the duration of the study, up to 7 years The MTD is defined as the dose that produces dose limiting toxicity (DLT) in 33% of the patients.
Progression-free Survival at 8 Months 8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney Defined as the proportion of patients who are progression free (CR, PR and SD) at 8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (20% increase in the sum).
- Secondary Outcome Measures
Name Time Method To Determine the Safety of Sunitinib in Combination With Erlotinib For the duration of the study, up to 7 years Median Time to Progression For the duration of the study, up to 7 years The Kaplan-Meier method will be used to estimate the median time to progression.
Proportion of Patients Whose Best Overall Response is Complete Response, Partial Response, Stable Disease, or Progressive Disease From the start of treatment until the criteria for response is met. Maximum Percent Change in Tumor Measurement Baseline through end of study, up to 7 years The maximum percent change in Tumor Measurement is the greatest percent change in longest diameter (LD) for the target lesions from the baseline LD. For patients with no change in LD, the maximum percent change is the lowest increase in LD from the baseline LD.
Trial Locations
- Locations (4)
OHSU Knight Cancer Institute
🇺🇸Portland, Oregon, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Salem Hospital
🇺🇸Salem, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States