A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary purpose of this study is to determine whether LY2181308 in combination with docetaxel is safe and effective treatment for hormone refractory prostate cancer patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Docetaxel; Hormones; Prednisone

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate which is metastatic and/or unresectable

• Hormone refractory prostate cancer defined as progressive based by documented 2 increase Prostate specific antigen (PSA) values over a previous reference value.

• Eastern Cooperative Oncology Group (ECOG) status 0-2

• Adequate hematological functions, liver and renal functions

Exclusion Criteria:

• Known hypersensitivity to docetaxel or taxane therapy

• Documented central nervous system or leptomeningeal metastasis at time of study entry

• Had prior treatment with chemotherapy, bone-seeking radionuclides in past 6 weeks prior to enrollment, or radiotherapy involving more than 25% of marrow producing area.

• Evidence of painful and/or destructive bone metastases for which radiation therapy, bisphosphonates or bone-seeking radionuclides are necessary.

• Have received treatment in the last 30 day with a drug which has not received regulatory approval for any indication at the time of study entry.