DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])

• Status: Terminated
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: Male

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 objectives of this study are:

• To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots)

• To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures)

• A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novacea
• Treatments: Androgens; Calcitriol; Docetaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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