Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer

Phase 2 Terminated 21 enrolled California Cancer Consortium National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Gefitinib may stop the growth of kidney cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PEG-interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of kidney cancer. Giving gefitinib together with PEG-interferon alfa-2b may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gefitinib together with PEG-interferon alfa-2b works in treating patients with unresectable or metastatic kidney cancer.

Timeline

Start: 2004-09
Primary completion: 2011-03
Completion: 2011-03

Outcome

Missed primary endpoint

Stopped (Enrollment): “Protocol was closed due to slow accrual.”

paper gefitinib plus PEG-IFNα did not meet the pre-specified 6-month PFS rate >50%. PMID 21431345 ↗

Publications

Shek D, Longmate J, Quinn DI, Margolin KA, Twardowski P, Gandara DR, Frankel P, Pan CX, Lara PN Jr. A phase II trial of gefitinib and pegylated IFNalpha in previously treated renal cell carcinoma. Int J Clin Oncol. 2011 Oct;16(5):494-9. doi: 10.1007/s10147-011-0212-8. Epub 2011 Mar 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gefitinib	Small molecule	250 mg	Oral
Subject	Peginterferon alfa-2b	Protein / enzyme biologic	4 ug/kg	Subcutaneous