drugset / Trial / NCT00025116

ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

NCT00025116 ↗

Phase 2 Completed 40 enrolled NCIC Clinical Trials Group
RandomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of prostate cancer. It is not yet known which dose of ZD 1839 is more effective in treating prostate cancer that has not responded to hormone therapy. PURPOSE: Randomized phase II trial to compare different doses of ZD 1839 in treating patients who have prostate cancer that has not responded to hormone therapy.

Timeline

Start
2001-04-24
Primary completion
2003-06-05
Completion
2008-09-22

Outcome

Missed primary endpoint

paper Gefitinib did not result in any responses in PSA or objective measurable disease at either dose level. PMID 15659491 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Gefitinib Small molecule 250 mg Oral
Subject Gefitinib Small molecule 500 mg Oral

Indications