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Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00467077 |
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.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: PEG-interferon alfa-2b Drug: gefitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of ZD1839 (IRESSA®) and Pegylated Interferon Alfa 2b (PEG-Intron™) in Unresectable or Metastatic Renal Cell Carcinoma |
Estimated Enrollment: | 39 |
Study Start Date: | September 2004 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed renal cell carcinoma
No uncontrolled brain metastases
PATIENT CHARACTERISTICS:
No evidence of clinically active interstitial lung disease
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90089-9181 |
Study Chair: | Primo N. Lara, MD | University of California, Davis |
Investigator: | Corinne Turrell, CCRP | University of California, Davis |
Responsible Party: | University of California Davis Cancer Center ( Primo N. Lara ) |
Study ID Numbers: | CDR0000540598, CCC-PHII-40, ZENECA-AZ1839US/0227, UCD-200412338-4, UCD-ZD1839 |
Study First Received: | April 25, 2007 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00467077 |
Health Authority: | United States: Federal Government |
recurrent renal cell cancer stage IV renal cell cancer stage III renal cell cancer |
Interferon-alpha Interferon Type I, Recombinant Interferons Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Urologic Diseases |
Kidney Neoplasms Peginterferon alfa-2b Carcinoma, Renal Cell Kidney Diseases Interferon Alfa-2a Adenocarcinoma Gefitinib Interferon Alfa-2b Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors |
Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |