A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00642018

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 II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Hormone Refractory Prostate Cancer

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
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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
B: Experimental 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

Arms

Assigned Interventions

A: Active Comparator

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

B: Experimental

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

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

Contacts

Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559)

1-317-615-4559

Locations

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.	Recruiting
Augsburg, Germany, 86150
Contact: Eli Lilly
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.	Recruiting
Frankfurt, Germany, 60596
Contact: Eli Lilly
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.	Recruiting
Hannover, Germany, 30625
Contact: Eli Lilly
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.	Recruiting
Muenchen-Planegg, Germany, 82152
Contact: Eli Lilly
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.	Recruiting
Heilbronn, Germany, D-74078
Contact: Eli Lilly
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.	Recruiting
Homburg/Saar, Germany, 66421
Contact: Eli Lilly
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.	Recruiting
Heidelberg, Germany, 69115
Contact: Eli Lilly
Poland
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.	Recruiting
Kielce, Poland, 25-734
Contact: Eli Lilly
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.	Recruiting
Warsaw, Poland, 02-781
Contact: Eli Lilly
Puerto Rico
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.	Recruiting
San Juan, Puerto Rico, 00918
Contact: Eli Lilly
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.	Recruiting
Barcelona, Spain, 08036
Contact: Eli Lilly
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.	Recruiting
Pamplona, Spain, 31008
Contact: Eli Lilly
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.	Recruiting
Madrid, Spain, 28050
Contact: Eli Lilly
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.	Recruiting
Elda, Spain, 03600
Contact: Eli Lilly

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:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10461, H8Z-MC-JACR
Study First Received:	February 28, 2008
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00642018 History of Changes
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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Prednisone
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

Urogenital Neoplasms
Genital Diseases, Male
Hormones
Glucocorticoids
Docetaxel
Prostatic Neoplasms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms

Genital Diseases, Male
Glucocorticoids
Hormones
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009