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Sponsors and Collaborators: |
University of Nebraska National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00483561 |
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gefitinib together with etoposide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gefitinib together with etoposide works in treating patients with advanced prostate cancer that did not respond to hormone therapy.
Condition | Intervention | Phase |
Prostate Cancer |
Drug: etoposide Drug: gefitinib Procedure: immunoenzyme technique Procedure: laboratory biomarker analysis |
Phase II |
MedlinePlus related topics: | Cancer Prostate Cancer |
ChemIDplus related topics: | Etoposide Etoposide phosphate ZD1839 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | A Phase II Study Evaluating the Efficacy of Iressa Plus Etoposide in Patients With Advanced Hormone Refractory Prostate Cancer |
Estimated Enrollment: | 21 |
Study Start Date: | January 2004 |
Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized study.
Patients receive oral gefitinib once daily on days 1-28 and oral etoposide once daily on days 1-14. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection at baseline and periodically during study for correlative studies. Blood samples are analyzed by enzyme-linked immunosorbent assays for biomarkers (e.g., VEGF, basic fibroblast growth factor, and anti-EGFR antibody titers) in order to determine whether one or more of these biomarkers can predict repsonse.
After completion of study therapy, patients are followed periodically.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone-refractory disease, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
No evidence of clinically active interstitial lung disease
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior palliative radiotherapy
United States, Nebraska | |||||
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Recruiting | ||||
Omaha, Nebraska, United States, 68198-6805 | |||||
Contact: Mary Mailliard, RN, BSN, OCN 402-559-5582 mjmailli@unmc.edu |
University of Nebraska |
National Cancer Institute (NCI) |
Study Chair: | Ralph Hauke, MD | University of Nebraska |
Investigator: | Elizabeth C. Reed, MD | University of Nebraska |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000549505, UNMC-28503, ZENECA-UNMC-28503 |
First Received: | June 6, 2007 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00483561 |
Health Authority: | Unspecified |
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