Status:
TERMINATED
DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])
Lead Sponsor:
Novacea
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is: * To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer The secondary...
Eligibility Criteria
Inclusion
- Histopathologically or cytologically proven adenocarcinoma of the prostate
- Documented metastatic prostate adenocarcinoma
- Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status \<= 2
- Adequate hematologic, renal and hepatic function
- Life expectancy \>= 3 months
Exclusion
- Prior chemotherapy, except estramustine
- Prior chemotherapy with docetaxel
- Prior isotope therapy (e.g., strontium-89, samarium-153, etc.)
- One or more contraindications to the use of corticosteroids
- History of cancer-related hypercalcemia
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00273338
Start Date
January 1 2006
End Date
November 1 2007
Last Update
November 6 2007
Active Locations (222)
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1
Birmingham Hematology & Oncology Associates, LLC
Birmingham, Alabama, United States, 35223
2
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States, 35661
3
Alaska Clinical Research Center
Anchorage, Alaska, United States, 99508
4
Hematology Associates - AOA
Phoenix, Arizona, United States, 85012