Clinical Trial: Cabozantinib-S-Malate, Crizotinib, Volitinib, or Sunitinib Malate in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastati

Brief Summary: This randomized phase II trial studies how well cabozantinib-s-malate, crizotinib, volitinib, or sunitinib malate work in treating patients with kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate, crizotinib, volitinib, and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To compare progression-free survival (PFS) in patients with metastatic papillary renal cell carcinoma (mPRCC) treated with sunitinib malate (sunitinib) to PFS in patients with mPRCC treated with MET kinase inhibitors.

SECONDARY OBJECTIVES:

I. To compare Response Evaluation Criteria in Solid Tumors (RECIST) response rate (RR; defined as the combined rate of confirmed and unconfirmed partial response [PR] and complete response [CR]) in patients with mPRCC treated with sunitinib to RR in patients treated with putative MET inhibitors.

II. To compare overall survival (OS) in patients with mPRCC treated with sunitinib to OS in patients with mPRCC treated with putative MET inhibitors.

III. To compare the safety profile of sunitinib and putative MET inhibitors in patients with mPRCC.

TERTIARY OBJECTIVES:

I. To evaluate the prognostic and predictive value of MET mutations, MET copy number or other markers of MET signaling in patients with mPRCC treated with putative MET inhibitors.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

ARM I: Patients receive sunitinib malate orally (PO) on days 1-28.

ARM II: Patients receive cabozantinib-s-malate PO on days 1-42.

ARM III: Patients receive crizotinib PO twice daily (BID) on days 1-42.

ARM IV: Patients receive volitinib PO on days 1-42.

A proportional hazards model will be used to evaluate each pair wise treatment comparison of PFS, adjusting for the two stratification factors as covariates in the model.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 [ Time Frame: Up to 3 years ]
    Toxicity defined as any grade 3 or 4 non-hematologic toxicity.
  • OS [ Time Frame: Up to 3 years ]
    The method of Kaplan and Meier will be used to estimate survival curves. The log-rank test will be used to compare OS between the 4 treatment arms.
  • RR [ Time Frame: Up to 3 years ]
    The Chi-Square test will be used to compare RR between the control arm of sunitinib malate and the MET inhibitor treatment arms.


Original Secondary Outcome: Same as current

Information By: National Cancer Institute (NCI)

Dates:
Date Received: May 2, 2016
Date Started: April 2016
Date Completion:
Last Updated: May 18, 2017
Last Verified: May 2017