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

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 Metastatic Papillary Renal Carcinoma (PAPMET)

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 tumour cells by blocking some of the enzymes needed for cell growth.

Trial Description

Primary Outcome:

  • Progression free survival (PFS)
Secondary Outcome:
  • Incidence of toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0
  • Overall survival (OS)
  • Response rate (RR)
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 Tumours (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. In all arms, courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 3 years.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society