Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00577356 |
Recruitment Status :
Terminated
(Safety reasons, though no safety issues arose.)
First Posted : December 20, 2007
Results First Posted : January 20, 2011
Last Update Posted : January 20, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Drug: Docetaxel Biological: CG1940/CG8711 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial of Neoadjuvant Docetaxel and CG1940/CG8711 Followed by Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | September 2008 |

- Drug: Docetaxel
Docetaxel 75mg/m2 will be given intravenously every 3 weeks for four cycles.Other Name: Taxotere
- Biological: CG1940/CG8711
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
- Number of Participants With Pathological Complete Response. [ Time Frame: The study evaluates 4 months of docetaxel and immunotherapy prior to radical prostatectomy followed by radical prostatectomy with an additional 3 months of immunotherapy after radical prostatectomy. ]CG1940/CG8711 was given along with docetaxel over a series of treatment prior to radical prostatectomy. Pathology of resected specimen was done to determine complete response, defined as no microscopic evidence of neoplastic cells in the resected specimen

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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%.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577356
United States, Washington | |
Virginia Mason Medical Center | |
Seattle, Washington, United States, 98101 |
Principal Investigator: | Jacqueline Vuky, MD | Virginia Mason Medical Center |
Responsible Party: | Jacqueline Vuky, MD, Virginia Mason Medical Center |
ClinicalTrials.gov Identifier: | NCT00577356 |
Other Study ID Numbers: |
IRB07028 I-0057 IST# 16194 |
First Posted: | December 20, 2007 Key Record Dates |
Results First Posted: | January 20, 2011 |
Last Update Posted: | January 20, 2011 |
Last Verified: | November 2010 |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases |
Docetaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |