Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer

AstraZeneca

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-Metastatic Prostate Cancer

Treatments: Drug: Gefitinib, radiotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00239291

1839IL/0118

Details and patient eligibility

About

To estimate the safety and tolerability of 250 mg ZD1839 given concurrently with 3D-CRT in patients with non-metastatic prostate cancer

Enrollment: 42 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biopsy confirmation of localised (T2) or locally advanced (T3) prostate cancer
• PSA below 20 ng/mL
• Lymph node negative
• Non-metastatic
• Written informed consent

Exclusion criteria

• Well differentiated stage T2 prostate cancer (Gleason score 2 to 4)
• Distant or nodal metastases
• Prostatectomy
• Concomitant LHRH analog treatment
• Previous or concomitant anti-androgens
• Active ILD

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)