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

NCT00577356 | Terminated Phase 2 Results DMC

• 3 other identifiers: IRB07028I-0057IST# 16194
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Pathological Complete Response.

  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

  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.

Interventions

Docetaxel DRUG

Docetaxel 75mg/m2 will be given intravenously every 3 weeks for four cycles.

Also known as: Taxotere

CG1940/CG8711 BIOLOGICAL

Immunotherapy allogeneic GM-CSF secreting cellular vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benaroya Research Institute: lead
• Cell Genesys: collaborator
• Sanofi: collaborator

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

the trial was closed prior to planned accrual of 30 patients due to an external report from the randomized trial of docetaxel and CG1940/CG8711 resulting in a higher incidence of deaths compared to docetaxel alone in metastatic prostate cancer.

Results Point of Contact

• Title: Jacqueline Vuky, MD
• Organization: Virginia Mason Medical Center

Jacqueline.Vuky@vmmc.org

(206) 223-6193

Study Officials

• Jacqueline Vuky, MD

  Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: February 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 20, 2011
• Results First Posted: January 20, 2011

Record last verified: 2010-11

Locations

US (1)