Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery
|Recurrent Renal Cell Carcinoma Stage III Renal Cell Cancer Stage IV Renal Cell Cancer Type 1 Papillary Renal Cell Carcinoma Type 2 Papillary Renal Cell Carcinoma||Drug: Erlotinib Hydrochloride Other: Laboratory Biomarker Analysis Drug: Tivantinib||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination With Erlotinib in Papillary Renal Cell Carcinoma|
- Response rate (confirmed complete response or partial response), determined according to Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 3 years ]
- Frequency and severity of toxicities, graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 3 years ]Summarized by arm by examining the frequency and severity of toxicities, the frequency and extent of required dose modifications, and the frequency and cause of patient withdrawal for reasons other than progression.
- PFS [ Time Frame: 4 months ]
- Role of c-MET [ Time Frame: Baseline ]Explored through the use of Cox regression, categorical analysis (responders/non-responders versus high expressors, etc.), and graphical presentations.
- Role of EGFR [ Time Frame: Baseline ]Explored through the use of Cox regression, categorical analysis (responders/non-responders versus high expressors, etc.), and graphical presentations.
|Actual Study Start Date:||August 20, 2012|
|Study Completion Date:||April 30, 2017|
|Primary Completion Date:||April 30, 2017 (Final data collection date for primary outcome measure)|
Experimental: Arm I (tivantinib)
Patients receive tivantinib PO BID on days 1-28.
Other: Laboratory Biomarker Analysis
Correlative studiesDrug: Tivantinib
Experimental: Arm II (tivantinib and erlotinib hydrochloride)
Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28.
Drug: Erlotinib Hydrochloride
Given POOther: Laboratory Biomarker Analysis
Correlative studiesDrug: Tivantinib
I. To assess the response rate (confirmed complete and partial response) of patients with locally advanced or metastatic papillary renal cell carcinoma treated with either ARQ 197 (tivantinib) or ARQ 197 combined with erlotinib (erlotinib hydrochloride).
I. To assess the progression free survival (PFS) of patients with locally advanced or metastatic papillary renal cell carcinoma treated with either ARQ 197 or ARQ 197 combined with erlotinib.
II. To assess the safety and tolerability of ARQ 197 therapy and ARQ 197 combined with erlotinib.
III. To descriptively assess the role of prior treatment on outcome.
I. To bank tissue specimens for future use and once funding is obtained to evaluate the expression of tissue correlative biomarkers such as hepatocyte growth factor receptor (c-MET) and epidermal growth factor receptor (EGFR), and to perform exploratory correlation with clinical outcomes.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive tivantinib orally (PO) twice daily (BID) on days 1-28.
ARM II: Patients receive tivantinib PO BID and erlotinib hydrochloride PO once daily (QD) on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for up to 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01688973
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|Principal Investigator:||Przemyslaw Twardowski||Southwest Oncology Group|