Clinical Trial: Axitinib in1st Line Treatment for Patients With Advanced or Metastatic Papillary Renal Cell Carcinoma

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

Official Title: Multicenter Phase II Study of Axitinib in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)

Brief Summary: Multicenter, single arm, phase II study using a A'Hern single-stage procedure in patients with locally advanced or metastatic papillary renal cell carcinoma (PRCC) in first-line treatment.

Detailed Summary:

Renal cell carcinoma (RCC) accounts for 2-3% of all adult malignancies worldwide, representing the seventh most common cancer in men and the ninth in women. The annual incidence is more than 337 000 cases and around 140 000 persons die every year. Half of patients with RCC are going to develop metastases, either with synchronous metastatic sites (25%) or during the follow up (25%).

Papillary renal cell carcinoma (PRCC) represents 10-15% of RCC and is characterized by a cytogenetic profile distinct from other types of renal cancer. Histologically, PRCC could be separated in 2 distinct subtypes: type 1 and type 2.

Vascular endothelial growth factor (VEGF) is a potent induction factor, playing a central role in angiogenesis and vascular permeability of tumor tissues. It binds to three specific receptors: VEGFR-1, VEGFR-2 and VEGFR-3, which are thus implicated in pathologic angiogenesis, tumor growth and metastatic progression of cancer. Patients with papillary histology demonstrated high expression of VEGF and VEGFR-2, making VEGF-targeted therapy an attractive therapeutic option.

Recently, several studies have been developed to assess VEGF targeted therapy in patients with PRCC, mostly with sunitinib and with poor results (median progression-free survival (PFS) around 6 months).

Axitinib is a potent, selective second-generation inhibitor of all three VEGF receptors. By inhibiting VEGF-mediated endothelial cell proliferation and survival, axitinib inhibits angiogenesis and tumor growth.

In phase II trials, axitinib has shown anti-tumor activity with well-tolerated clinical safety profile in patients with advanced solid tumors, including RCC.

24-week progression-free rate



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The safety of axitinib in patients with PRCC (NCI CTCAE v4) [ Time Frame: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18 ]
  • The progression-free survival (RECIST 1.1) in each PRCC subtypes [ Time Frame: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18 ]
  • The overall survival [ Time Frame: 43 month after first inclusion ]
  • The best response [ Time Frame: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18 ]
    the best response recorded from the start of the treatment until disease progression
  • the objective response rate [ Time Frame: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18 ]
  • the duration of response [ Time Frame: Week 2, 4, 8, 16 then Month 4, 6, 8,10, 12, 14, 16,18 ]


Original Secondary Outcome: Same as current

Information By: Centre Leon Berard

Dates:
Date Received: June 19, 2015
Date Started: October 2015
Date Completion: January 2019
Last Updated: April 1, 2016
Last Verified: April 2016