Erlotinib in Treating Patients With Locally Advanced or Metastatic Papillary Renal Cell Cancer

Stage IV Renal Cell Cancer Clinical Trial

Official title: A Phase II Study of OSI-774 (NSC-718781) in Patients With Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer

Status Completed

Clinical Trial Summary

This phase II trial is studying how well erlotinib works in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess response (confirmed complete and partial response) of patients with locally advanced or metastatic papillary histology renal cell cancer treated with OSI-774.

II. To assess the overall survival and 6-month probability of treatment failure of this group of patients.

III. To evaluate the qualitative and quantitative toxicities of this regimen. IV. To investigate in a preliminary manner the association of tumor response with tumor expression of epidermal growth factor receptor and status of von Hippel Lindau gene mutation.

OUTLINE:

Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-20 months. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Recurrent Renal Cell Cancer
• Stage III Renal Cell Cancer
• Stage IV Renal Cell Cancer

• NCT number: NCT00060307
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: May 2003