Lenvatinib and Everolimus in Renal Cell Carcinoma (RCC)
- Conditions
- Renal Cell Carcinoma
- Interventions
- Registration Number
- NCT03324373
- Lead Sponsor
- Yousef Zakharia
- Brief Summary
The purpose of this research study is to see what effect the combination of lenvatinib plus everolimus has in local and metastatic renal cell carcinoma to potentially make surgically unresectable tumors resectable.
- Detailed Description
This is a pilot interventional clinical trial at the University of Iowa Hospitals and Clinics, enrolling 15 subjects and lasting approximately 12 months. Eligible patients will start treatment with lenvatinib 18 mg PO daily (administered as one 10 mg capsule and two 4 mg capsules) and everolimus 5 mg PO daily for 4 weeks, constituting one cycle. Two cycles of treatment (8 weeks) will be administered followed by a 1-week wash out period during which time patients will be evaluated by the urology oncology team and appropriate surgery will be planned. The wash out period is for drug to be eliminated prior to surgery, to avoid bleeding/wound healing effects. This includes partial nephrectomy or radical nephrectomy. Following surgery, patients with no evidence of disease will have active surveillance. Patients who continue to have disease following surgery will receive further systemic treatment for metastatic disease.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lenvatinib and Everolimus prior to cytoreductive nephrectomy Partial or Radical Cytoreductive Nephrectomy Eligible patients will start treatment with lenvatinib 18 mg PO daily (administered as one 10 mg capsule and two 4 mg capsules) and everolimus 5 mg PO daily for 4 weeks constituting one cycle. Two cycles of treatment will be administered and after 2 weeks wash out period, the patients will go for nephrectomy. Lenvatinib and Everolimus prior to cytoreductive nephrectomy Lenvatinib Eligible patients will start treatment with lenvatinib 18 mg PO daily (administered as one 10 mg capsule and two 4 mg capsules) and everolimus 5 mg PO daily for 4 weeks constituting one cycle. Two cycles of treatment will be administered and after 2 weeks wash out period, the patients will go for nephrectomy. Lenvatinib and Everolimus prior to cytoreductive nephrectomy Everolimus Eligible patients will start treatment with lenvatinib 18 mg PO daily (administered as one 10 mg capsule and two 4 mg capsules) and everolimus 5 mg PO daily for 4 weeks constituting one cycle. Two cycles of treatment will be administered and after 2 weeks wash out period, the patients will go for nephrectomy.
- Primary Outcome Measures
Name Time Method Surgical complications as assessed by Clavien-Dindo classification system Assessment will be completed at the first post-operative visit within 4-6 weeks after surgery. To determine whether there is increased surgical morbidity with lenvatinib and everolimus prior to nephrectomy as assessed by Clavien complications.
- Secondary Outcome Measures
Name Time Method Comparison of surgical outcomes to historical controls Within two years following the last study participant's surgery Review estimated blood loss, blood transfusion, operative time, adjacent organ injury, and postoperative complications.
Treatment related adverse events as assessed by CTCAE criteria, version 4.03 First treatment through 5 years after Cycle 1, Day 1 or death. To assess whether patients will tolerate the combination of lenvatinib and everolimus prior to surgery with same rate of toxicities as seen in prior Phase II clinical trials.
Changes in overall response rate as assessed by RECIST 1.1 Screening (within 14 days of Day 1) and pre-surgery (week 9-10). 1) If metastatic disease followup monthly or 2) if no evidence of disease followup every three months until five years or death. Response and progression will be evaluated using RECIST 1.1. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the criteria. Imaging includes conventional computed tomography (CT) and/or magnetic resonance imagining (MRI), bone scan, and positron emission tomography-computed tomography (PET-CT)
Trial Locations
- Locations (1)
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States