Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients

Phase 3

Terminated

• Conditions: Prostate Cancer
• Interventions: Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine; Drug: Chemotherapy (docetaxel and prednisone)

• Registration Number: NCT00133224
• Lead Sponsor: Cell Genesys

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-08-19
• Study First Submitted QC: 2005-08-19
• Study First Posted: 2005-08-23
• Primary Completion: 2008-08
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-19
• Last Update Posted: 2008-09-23
• Study Completion: 2009-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 408

Inclusion 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Immunotherapy allogeneic GM-CSF secreting cellular vaccine	-
2	Chemotherapy (docetaxel and prednisone)	-

Primary Outcome Measures

Name	Time	Method
Survival	0

Secondary Outcome Measures

Name	Time	Method
Time to disease progression. Time to pain progression.	0

Trial Locations

Locations (113)

Alaska Clinical Research Center; 🇺🇸 Anchorage, Alaska, United States

St. Edward Mercy Medical Center; 🇺🇸 Fort Smith, Arkansas, United States

Loma Linda University; 🇺🇸 Loma Linda, California, United States

Onocology Care Medical Associates; 🇺🇸 Los Angeles, California, United States

Desert Hematology Oncology Medical Group; 🇺🇸 Rancho Mirage, California, United States

San Bernardino Urology Associates; 🇺🇸 San Bernardino, California, United States

Kaiser Permanente Medical Group Dept. of Oncology Research; 🇺🇸 San Diego, California, United States

Sharp Healthcare; 🇺🇸 San Diego, California, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

UCSF Mt. Zion Cancer Center; 🇺🇸 San Francisco, California, United States

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