Docetaxel and Diethylstilbestrol in the Treatment of Androgen Independent Prostate Cancer
Summary
This study is for men who have prostate cancer that has spread outside of the prostate gland and is no longer responding to hormone removal therapy. This study is designed to determine if a new drug combination will help to control the cancer. The medicines being used, docetaxel and diethylstilbestrol (DES), have been given to patients with prostate cancer and each drug has demonstrated activity in prostate cancer, either used alone or in other combinations. The objective of this study is to determine the effect of this drug combination on the prostate cancer and its response to disease progression.
Description
This is a single arm phase II trial of docetaxel and diethylstilbestrol for patients with symptomatic stage D3 androgen independent prostate cancer. Patients will receive docetaxel weekly for 10 cycles (each cycle consists of treatment for 3 weeks out of every 4) and DES daily for 40 weeks or until there is evidence of disease progression, whichever occurs first. Patients will be followed to determine PSA and objective response. Additional endpoints include time to progression, disease specific survival and overall survival. Disease progression will be defined as 2 consecutive increases in PSA and/or tumor growth as evidenced by examination or radiologic evaluation. Other secondary objectives will be to determine the toxicity, and impact on quality of life of this regimen.
Study Design
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Prostate Cancer
Intervention
Docetaxel and Diethylstilbestrol (DES)
Status
Completed
Source
Fred Hutchinson Cancer Research Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00136526
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Prostate-specific Antigen
A glycoprotein that is a kallikrein-like serine proteinase and an esterase, produced by epithelial cells of both normal and malignant prostate tissue. It is an important marker for the diagnosis of prostate cancer.
Diethylstilbestrol
A synthetic nonsteroidal estrogen used in the treatment of menopausal and postmenopausal disorders. It was also used formerly as a growth promoter in animals. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), diethylstilbestrol has been listed as a known carcinogen. (Merck, 11th ed)
Fenretinide
A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.
Ultrasound, High-intensity Focused, Transrectal
Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).
Prostatic Secretory Proteins
Proteins secreted by the prostate gland. The major secretory proteins from the human prostate gland include PROSTATE-SPECIFIC ANTIGEN, prostate-specific acid phosphatase, prostate-specific membrane antigen, and prostate-specific protein-94.
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PubMed Articles
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