Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer
This study has been terminated.
(Safety reasons, though no safety issues arose.)
Information provided by:
Benaroya Research Institute
First received: December 18, 2007
Last updated: January 18, 2011
Last verified: November 2010
The purpose of this study is to find out what effects, good and bad, the combination of docetaxel with CG1940/CG8711 (immunotherapy drugs) have on destroying prostate cancer before removal the prostate (prostatectomy).
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Trial of Neoadjuvant Docetaxel and CG1940/CG8711 Followed by Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2008 (Final data collection date for primary outcome measure)
Docetaxel 75mg/m2 will be given intravenously every 3 weeks for four cycles.
Other Name: Taxotere
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients must have clinical stage 1-3 disease and no radiographic evidence of metastatic disease
- Nomogram Prediction: Patients must have a Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of <60%.
- Concurrent or prior treatment with radiation, cytotoxic or biologic therapy for prostate cancer, prior hormonal therapy (except finasteride or dutasteride for obstructive voiding symptoms)
- Male patients unwilling to use effective means of contraception are excluded. Contraception should be continued for 3 months after treatment.
- Prior malignancy will not exclude the patient. (Patients can not have active cancer or be undergoing active treatment). The Principal Investigator will make final decision regarding eligibility since the end point is pathological complete response.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577356
|Virginia Mason Medical Center
|Seattle, Washington, United States, 98101 |
Benaroya Research Institute
||Jacqueline Vuky, MD
||Virginia Mason Medical Center
No publications provided
||Jacqueline Vuky, MD, Virginia Mason Medical Center
History of Changes
|Other Study ID Numbers:
||IRB07028, I-0057, IST# 16194
|Study First Received:
||December 18, 2007
|Results First Received:
||September 13, 2010
||January 18, 2011
||United States: Food and Drug Administration
United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2014
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Molecular Mechanisms of Pharmacological Action