Gefitinib and Etoposide in Treating Patients With Advanced Prostate Cancer That Did Not Respond to Hormone Therapy
|ClinicalTrials.gov Identifier: NCT00483561|
Recruitment Status : Terminated (PI left UNMC)
First Posted : June 7, 2007
Last Update Posted : January 31, 2018
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Gefitinib plus etoposide||Phase 2|
- Determine the activity of gefitinib and etoposide, in terms of overall response rate, in patients with hormone-refractory advanced prostate cancer previously treated with docetaxel-based therapy.
- Determine the toxicity of this regimen in these patients.
- Determine whether related biomarkers can help predict response in patients treated with this regimen.
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 response.
After completion of study therapy, patients are followed periodically.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Evaluating the Efficacy of Iressa Plus Etoposide in Patients With Advanced Hormone Refractory Prostate Cancer|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Experimental: Gefitinib plus Etoposide
Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial.
Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).
Drug: Gefitinib plus etoposide
Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial with Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).
- Overall response rate as measured by RECIST criteria [ Time Frame: After 14 patients are enrolled ]If there is at least 1 response, then 7 additional patients will be enrolled. If there are 4 or more responders overall, then the combination will be considered active and warrant further study.
- Adverse events and toxicities as assessed by NCI CTC v2.0 [ Time Frame: When reported by patients, and at physical evaluations ]
- Laboratory values [ Time Frame: At every cycle ]
- Biomarkers [ Time Frame: At every cycle ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483561
|United States, Nebraska|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-6805|
|Principal Investigator:||Ralph Hauke, MD||University of Nebraska|
|Principal Investigator:||Elizabeth C. Reed, MD||University of Nebraska|