A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/5/2019 |
| Start Date: | March 2008 |
| End Date: | April 2012 |
A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Hormone Refractory Prostate Cancer
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.
docetaxel is safe and effective treatment for hormone refractory prostate cancer patients.
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.
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