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Prednisone Oral |
Deltasone |
Clinical Trial: Docetaxel in Combination with GVAX ® Vaccine for Prostate Cancer Vs Docetaxel and Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer With Pain
This study is currently recruiting patients.
Verified by Cell Genesys August 2005
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Purpose
The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment.
| Condition | Intervention | Phase |
|---|---|---|
| Prostate Cancer | Vaccine: Immunotherapy allogeneic GM-CSF secreting cellular vaccine Drug: Chemotherapy (docetaxel and prednisone) | Phase III |
MedlinePlus related topics: Prostate Cancer
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III 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
Further Study Details:
Expected Total Enrollment: 600
Study start: July 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Male
Criteria
- Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
- Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
- Detectable metastases
- ECOG performance status ≤2 (Performance status of 3 if due to bone pain)
- Any Gleason score
- Only one prior treatment with systemic chemotherapy
- No prior treatment with gene therapy
- No prior immunotherapy for prostate cancer
- Taxane Naïve
- Experiencing cancer-related pain
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00133224
Florida
Integrated Community Oncology Network, Jacksonville, Florida, 32207, United States; Recruiting
Diane Edwards 904-363-7471
Yousif Abubakr, MD, Principal Investigator
Yousif Abubakr, MD, Principal Investigator
Ohio
Gabrail Cancer Center, Canton, Ohio, 44718, United States; Recruiting
Carrie Smith 330-492-3345
Nashat Gabrail, MD, Principal Investigator
Nashat Gabrail, MD, Principal Investigator
More Information
Study ID Numbers: G-0034; VITAL-2
Last Updated: August 22, 2005
Record first received: August 19, 2005
ClinicalTrials.gov Identifier: NCT00133224
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 22, 2005
Record first received: August 19, 2005
ClinicalTrials.gov Identifier: NCT00133224
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
Resources
- Deltasone (Drug Digest)
- Prednisone Oral (Drug Digest)
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