UROLOGY MAIN SITE GEN. ADULT UROLOGY UROLOGIC ONCOLOGY MALE UROLOGY TRANSPLANT PROGRAM
PELVIC MEDICINE, INCONTINENCE & RECONST. SURGERY PEDIATRIC UROLOGY MIN. INVASIVE SURGERY
About Us
Our History
Faculty Information
Conditions
Innovations & Technology
Research & Clinical
Trials
For Patients
Academic Information
News & Events
Useful Links
Department Directory
Facilities & Directions
How You Can Help
Contact Us
Department of
Urology Intranet

Clinical Trial Details

Trial Information
 
Trial:  Prostate Cancer- Chemo therapy with or without vaccine in patients with hormone refractory metastatic disease
   
 
Principal Investigator:  Allan Pantuck, MD, MS, FACS
Co-Investigator(s):  Jean B. deKernion, MD; Arie Belldegrun, MD; Mark S. Litwin, MD, MPH; Robert E. Reiter, MD;
   
This trial is currently accepting new patient applications.  (Apply)


Objective
 

A Phase 3 Randomized, Open-Label Study of Docetaxel in Combination with CG1940 and CG8711 versus Docetaxel and Prednisone in Taxane-Naïve Patients with Metastatic Hormone-Refractory Prostate Cancer With Pain (Cell Genesys Protocol G-0034, Dated August 2, 2005)  IRB #  05-11-089-01


Patient Eligibility
 

INCLUSION CRITERIA

1.       Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate

2.       Males greater than 18 years of age

3.       Patients taking any Level 3 pain medication at any dose with any frequency. Patients taking Level 2 pain medication for cancer related pain, confirmed by investigator assessment.

4.       Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy (after discontinuation of anti-androgen therapy) as determined by one of the following:

·         Progressive measurable disease on CT scan or MRI as

assessed using un-modified RECIST guidelines

·         Progressive non-measurable disease as defined by the

appearance of one or more new lesions on bone scan

·         PSA progression, as defined by two consecutive rising PSA

values obtained at least 2 weeks apart, and both obtained at

least 4 weeks after discontinuation of any other anti-

androgen therapy. The second PSA value must be 5.0

ng/mL.

 

5.       Detectable metastases by bone scan, CT scan or MRI.

 

EXCLUSION CRITERIA

  1. Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
  2. Clinical evidence of brain metastases or history of brain metastases
  3. Third space fluid accumulation, such as ascites or symptomatic pleural effusion
  4. Clinically significant active infection or uncontrolled medical condition considered high-risk for docetaxel, corticosteroids or investigational new drug treatment
  5. Prior gene therapy or cancer vaccine for prostate cancer
  6. More than one prior systemic chemotherapy regimen, or any taxane chemotherapy. Patients must have completed chemotherapy at least 4 weeks prior to randomization and have recovered from all side effects.
  7. Radiation therapy within 4 weeks of randomization. Prior radiation must have been to less than 30% of the bone marrow and patient has recovered from all side effects. Prior use of samarium is acceptable; patients cannot have received strontium


For More Information
  For additional information on inclusion and exclusion criteria and whether or not you may be a candidate to participate in a trial, call Nazy Zomorodian, Director for the Clinical Trials Office at (310) 825-5538.