E3-Hormone Refractory Prostrate Cancer Taxotere Combination

Sanofi

Status and phase

Completed

Phase 2

Conditions

Hormone Refractory

Metastatic

Prostate Cancer

Treatments

Drug: Docetaxel

Drug: Zactima (vandetanib)

Drug: Prednisolone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00498797

2005-003593-16 (EudraCT Number)

D4200C00055

Details and patient eligibility

About

The purpose of this study is to determine whether treatment with Zactima (vandetanib) in combination with Docetaxel and Prednisolone is more effective than the standard Docetaxel and Prednisolone alone for prostate cancer, in patients with Hormone refractory prostate cancer who have not previously received chemotherapy.

Enrollment

86 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Metastatic hormone refractory prostate cancer defined as those patients with evidence of progression of disease in spite of castrate levels of testosterone indicated by rising levels of PSA
No previous chemotherapy although those patients that have received estramustine can enter the study provided the estramustine was stopped 3 weeks before dosing of study drug
screening PSA values >20ng/ml. this must be confirmed by two separate measurements at least 2 weeks apart

Exclusion criteria

Treatment within 4 weeks before randomization and/or whilst on study, treatment with the following: 1)non-approved or experimental drug, 2)treatment with a drug with similar mechanism of action to ZD6474
concurrent treatment with other anticancer agents, othr than docetaxel and prednisolone as defined in the protocol