Gefitinib and PEG-Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
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.
Biological: PEG-interferon alfa-2b
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of ZD1839 (IRESSA®) and Pegylated Interferon Alfa 2b (PEG-Intron™) in Unresectable or Metastatic Renal Cell Carcinoma|
- Progression-free status at 6 months [ Time Frame: at end of study ] [ Designated as safety issue: No ]
- Response rate as measured by RECIST criteria [ Time Frame: at end of study ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: at end of study ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: at end of study ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: at end of study ] [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Biological: PEG-interferon alfa-2b
- Determine the 6-month progression-free survival of patients with unresectable or metastatic renal cell carcinoma treated with gefitinib and PEG-interferon alfa-2b.
- Determine the response rate (by RECIST criteria), duration of response, time to treatment failure, and overall survival of patients treated with this regimen.
- Assess toxicity and tolerability of this regimen in these patients.
- Determine the pre-treatment expression of the von Hippel-Lindau (VHL) protein, the epidermal growth factor receptor (EGFR), and p27, and correlate with response to treatment.
- Determine post-treatment alteration of EGFR and p27 expression in patients with tumors accessible for serial biopsy.
- Assess changes in EGFR levels in buccal epithelial cells in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once daily and PEG-interferon alfa-2b subcutaneously once weekly in weeks 1-6. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial response or stable disease after completion of course 2 continue to receive gefitinib alone as above in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 2 years.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467077
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90089-9181|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|Study Chair:||Primo N. Lara, MD||University of California, Davis|