Clinical Trial: Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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

Detailed Summary:

PRIMARY OBJECTIVES:

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).

SECONDARY OBJECTIVES:

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.

TERTIARY OBJECTIVES:

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, p
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Response rate (confirmed complete response or partial response), determined according to Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 3 years ]

Original Primary Outcome: Response rate (confirmed complete response [CR] or partial response [PR]), determined according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 3 years ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Frequency and severity of toxicities, graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 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 ]


Information By: National Cancer Institute (NCI)

Dates:
Date Received: September 14, 2012
Date Started: August 2012
Date Completion:
Last Updated: April 4, 2017
Last Verified: March 2017