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.
|Kidney Cancer||Biological: PEG-interferon alfa-2b Drug: gefitinib||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
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|
- Six-month Progression-free Survival [ Time Frame: From the date treatment started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months ]Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions
- Number of Participants With Overall Response as Measured by RECIST Criteria [ Time Frame: After 2 cycles of treatment, up to 2 years. ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response = CR + PR
- Progression-Free Survival [ Time Frame: Until disease progression, up to 5 years. ]Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Overall Survival [ Time Frame: Up to 5 years. ]Estimated using the product-limit method of Kaplan and Meier.
|Study Start Date:||September 2004|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Experimental: Gefitinib and PEG-IFNa Treatment
Gefitinib administered at a dose of 250 mg orally once daily for 12 weeks. PEG-IFNa at 4.0 µg/kg/wk administered subcutaneously once weekly for 6 weeks (cycle repeated once for a total of 2 cycles).
Biological: PEG-interferon alfa-2b
PEG-Interferon will be administered subcutaneously (sq) once weekly for 6 weeksDrug: gefitinib
ZD1839 will be administered at a dose of 250 mg orally once daily,
- 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|