A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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
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 | |
| 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. | |
| Frankfurt, Germany, 60488 | |
| 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. | |
| Hannover, Germany, 30625 | |
| 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. | |
| Heidelberg, Germany, 69115 | |
| 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. | |
| Heilbronn, Germany, D-74078 | |
| 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. | |
| Homburg, Germany, 66421 | |
| 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. | |
| Muenchen-Planegg, Germany, 82152 | |
| 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. | |
| Gdansk, Poland, 80-219 | |
| 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. | |
| 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
| 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 Glucocorticoids Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 22, 2013