Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer

This study has been terminated.
(Safety reasons, though no safety issues arose.)
Sponsor:
Collaborators:
Cell Genesys
Sanofi
Information provided by:
Benaroya Research Institute
ClinicalTrials.gov Identifier:
NCT00577356
First received: December 18, 2007
Last updated: January 18, 2011
Last verified: November 2010

December 18, 2007
January 18, 2011
February 2008
September 2008   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: Yes ]
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
- To evaluate the combination of docetaxel and CG1940/CG8711 on pathologic complete response (pCR) in radical prostatectomy specimens. Pathologic complete response is defined as no microscopic evidence of neoplastic cells in the resected specimen. [ 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. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00577356 on ClinicalTrials.gov Archive Site
Not Provided
Evaluate the toxicity of docetaxel and CG1940/CG8711 prior to surgical resection. Assessment of margin positivity at surgical resection. Evaluate PSA response from baseline and post treatment [ 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. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer
Phase II Trial of Neoadjuvant Docetaxel and CG1940/CG8711 Followed by Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer

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).

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
September 2008
September 2008   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00577356
IRB07028, I-0057, IST# 16194
Yes
Jacqueline Vuky, MD, Virginia Mason Medical Center
Benaroya Research Institute
  • Cell Genesys
  • Sanofi
Principal Investigator: Jacqueline Vuky, MD Virginia Mason Medical Center
Benaroya Research Institute
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP