5342S-12: S1107 papillary kidney

SWOG 1107: Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination With Erlotinib in Papillary Renal Cell Carcinoma

Type of Study
Cancer (Oncology) - Kidney
Swedish Cancer Institute
Short Description

Purpose: This randomized phase II trial studies how well tivantinib (ARQ 197) with or without erlotinib hydrochloride works in treating patients with metastatic or locally advanced kidney cancer that cannot be removed by surgery. Tivantinib (ARQ 197) and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Temporarily Closed
Principal Investigator
Gary Goodman, M.D.
Eligibility Notes
  • Papillary histology renal cell carcinoma which is metastatic, or locally advanced and unresectable; mixed histologies will be allowed provided that they contain ≥ 50% of the papillary component
  • Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection
  • History of brain metastases who are asymptomatic and have not received steroid therapy in the 14 days prior to registration are eligible
  • May have received up to one prior systemic therapy for advanced or metastatic renal cell carcinoma; patients must not have received a MET inhibitor or erlotinib as prior therapy; at least 21 days must have elapsed since completion of prior systemic therapy, 42 days for nitrosoureas or mitomycin C
  • May have received prior radiation therapy, but must have measurable disease outside the radiation port; at least 21 days must have elapsed since completion of prior radiation therapy
  • Zubrod performance status of 0-2
  • Must be able to take oral medications
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
(206) 215-3086