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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00642018
First received: February 28, 2008
Last updated: May 24, 2012
Last verified: May 2012

February 28, 2008
May 24, 2012
March 2008
August 2011   (final data collection date for primary outcome measure)
  • To estimate the progression-free survival (PFS)in patients with HRPC administered LY2181308 sodium plus docetaxel compared to docetaxel alone [ Time Frame: 26 months ] [ Designated as safety issue: Yes ]
  • Safety [ Time Frame: 26 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00642018 on ClinicalTrials.gov Archive Site
  • Adverse event profile of combination [ Time Frame: 26 months ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: 22 months ] [ Designated as safety issue: Yes ]
  • PSA kinetics [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • Patient reported outcomes [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • Estimate overall survival [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • Estimate duration of overall response [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • Assess biomarker responses [ Time Frame: 22 months ] [ Designated as safety issue: Yes ]
  • Evaluate clinical symptoms [ Time Frame: 26 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: docetaxel
    Docetaxel 75 mg/m2 intravenously on day one of every 21 days. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.
  • Drug: LY2181308 sodium
    LY2181308 administered weekly plus docetaxel 75 mg/m2 intravenously administered every 21 days. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.
  • Drug: Prednisone
    Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy
  • Active Comparator: A
    SOC docetaxel 75 mg/m2 IV every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel therapy
    Interventions:
    • Drug: docetaxel
    • Drug: Prednisone
  • Experimental: B
    LY2181308 administered with docetaxel 75 mg/m2 IV every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel
    Interventions:
    • Drug: docetaxel
    • Drug: LY2181308 sodium
    • Drug: Prednisone
de Liaño AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
April 2012
August 2011   (final data collection date for primary outcome measure)

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 PSA values over a previous reference value.
  • 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 radionucleides 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, biophosphonates or boneseeking radionucleides 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.
Male
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Spain,   Poland,   United States
 
NCT00642018
10461, H8Z-MC-JACR
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP