Research & Trial Information

SCHEMA S1500

Protocol#: SWOG – S1500

Cancer Type: Renal

Patient Eligibility:

1. Patients must have histologically or cytologically confirmed papillary histology renal cell carcinoma which is metastatic or locally advanced disease not amenable to surgical resection. (NOTE: A designation of type I or type II should be made by the local pathologist if possible.) Mixed histologies containing type I or type II will be allowed provided that they contain ≥ 50% of the papillary component.
2. Patients must also have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension.
3. Patients with a history of treated brain metastases who are asymptomatic and have not received steroid therapy in the 14 days prior to registration are eligible. Anti-seizure medications are allowed provided they are non-enzyme inducing (e.g. topiramate, levatiracetam, gabapentin).
4. Patients must not have cavitating pulmonary lesions. Patients must not have tumor invading the GI tract or evidence of endotracheal or endobronchial tumor within 28 days prior to registration.
5. Patients may have received prior surgery. At least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery.
6. Patients may have received up to one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor FDA-approved for advanced RCC (i.e., pazopanib, bevacizumab, sorafenib or axitinib). If a patient develops metastatic disease within six months of discontinuation of adjuvant therapy, this will constitute one prior systemic therapy for advanced or metastatic RCC. If a patient develops metastatic disease and more than six months has elapsed since discontinuation of adjuvant therapy, this will not constitute prior systemic therapy for advanced or metastatic RCC. Patients may have also received prior immunotherapy. Patients must not have received a MET/HGF inhibitor or sunitinib as prior therapy. At least 14 days must have elapsed since completion of prior systemic therapy. Patients must have recovered from all associated toxicities at the time of registration.
7. Patients may have received prior radiation therapy, but must have measurable disease outside the radiation port. At least 14 days must have elapsed since completion of prior radiation therapy. Patients must have recovered from all associated toxicities at the time of registration.
8. Patients must not be taking, nor plan to take while on protocol treatment, strong CYP3A4 inhibitors.
9. Patients must not be receiving or planning to receive any other investigational agents.
10. Patients must have a Zubrod performance status of 0 – 1.
11. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for 3 years. Men receiving active surveillance for prostate cancer may also be enrolled.
12. Patients must be ≥ 18 years of age.