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
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: docetaxel
Drug: LY2181308 sodium
Drug: Prednisone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: March 2008
Study Completion Date: April 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
SOC docetaxel 75 mg/m2 IV every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel therapy
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: Prednisone
Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy
Experimental: B
LY2181308 administered with docetaxel 75 mg/m2 IV every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642018

Locations
United States, Tennessee
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Memphis, Tennessee, United States, 38138
Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Augsburg, Germany, 86150
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Frankfurt, Germany, 60488
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Hannover, Germany, 30625
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Heidelberg, Germany, 69115
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Heilbronn, Germany, D-74078
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Homburg, Germany, 66421
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Muenchen-Planegg, Germany, 82152
Poland
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Gdansk, Poland, 80-219
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Kielce, Poland, 25-734
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Olsztyn, Poland, 10-228
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Warsaw, Poland, 02-781
Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barcelona, Spain, 08036
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Benidorm, Spain, 03501
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Elda, Spain, 03600
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madrid, Spain, 28050
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pamplona, Spain, 31008
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00642018     History of Changes
Other Study ID Numbers: 10461, H8Z-MC-JACR
Study First Received: February 28, 2008
Last Updated: May 24, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Spain: Ministry of Health and Consumption
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Eli Lilly and Company:
Hormone Refractory Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Prednisone
Docetaxel
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Glucocorticoids
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014