Phase II, Open-Label Trial to Assess the Activity of ZD1839 (IRESSA TM) in Patients With Recurrent Prostate Cancer Who Have Rising Serum PSA Levels Despite Serum Testosterone < 50mg/dl
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Prostate Cancer
Both
Prostate Cancer
Trial Information
Phase II, Open-Label Trial to Assess the Activity of ZD1839 (IRESSA TM) in Patients With Recurrent Prostate Cancer Who Have Rising Serum PSA Levels Despite Serum Testosterone < 50mg/dl
Inclusion Criteria:
- Prostate cancer diagnosis
- no evidence of metastasis
- Age 18 or older
Exclusion Criteria:
- Prior chemotherapy for recurrent prostate cancer
- Radiotherapy completed within 28 days of starting the study
- Incomplete healing from prior cancer or other major surgery
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Serum Prostate Specific Antigen
Outcome Time Frame:
Monthly
Authority:
United States: Food and Drug Administration
Study ID:
1839US/0040
NCT ID:
NCT00635856
Start Date:
May 2001
Completion Date:
February 2003
Related Keywords:
- Prostate Cancer
- Iressa
- Gefitinib
- Prostate Cancer
- PSA
- Prostatic Neoplasms
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