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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

docetaxel

LY2181308 sodium

Prednisone

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Hormone Refractory Prostate Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A: Docetaxel

B: LY2181308 + Docetaxel

Arm Description

Standard of care (SOC) docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel therapy

LY2181308 administered with docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone

PFS is defined as the time from date of first dose to the first observation of progression of disease (PD) or death due to any cause. PD was determined using the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. For participants who had no PD or death, PFS was censored at their last contact. Participants were still followed for PFS after they stopped receiving study drug.

Number of Participants With Adverse Events (Safety)

Data are presented as number of participants who experienced serious adverse events or all other nonserious adverse events during the study including the 30-day follow-up period. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Event section. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months.

Secondary Outcome Measures

Adverse Event Profile

Data presented are the number of participants with all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), discontinuations due to SAEs and AEs, and deaths that occurred in this study that were assessed by investigators as possibly related to study drug. The participants received maximum 24 cycles of treatment (1cycle = 3 weeks). Safety data were collected up to 24 cycles plus 30 days of follow-up for a total up to 19 months.

Pharmacokinetics of Docetaxel: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-infinity)

Prostate Specific Antigen (PSA) Kinetics: Percentage of Participants With PSA Response (Response Rate)

PSA response was defined as a post-baseline PSA level decline of at least 50% relative to the baseline value. Response rate calculated as 100*n/N where n=the number of participants with responses and N=the total number of participants treated.

Estimate Overall Survival

Overall survival is defined as the time from date of first treatment to the date of death due to any cause. For participants who were alive, overall survival was censored at their last contact. Participants were still followed for overall survival after they stopped receiving study drug.

Estimate Duration of Overall Response

The duration of response [complete response (CR) or partial response (PR)] was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. CR or PR is classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. For participants who had no progression or death, the duration of response was censored at their last contact.

Percentage of Participants With Complete Response or Partial Response (Overall Response Rate)

Overall response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) per the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.

Change From Baseline to Day 21 in Granulocyte Colony Stimulating Factor(G-CSF) (Assess Biomarker Responses)

G-CSF [international units per milliliter (IU/mL)] was used to estimate biomarker responses and is presented as the percentage change from baseline.

Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) Total Score at 3 Months (Participant Reported Outcomes)

The FACT-P is a 39-item participant-rated questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms.

Functional Assessment of Cancer Therapy-General (FACT-G) Total Score at 3 Months (Evaluate Clinical Symptoms)

The total FACT-G is the sum of 4 subscale scores on the FACT-Prostate Cancer (FACT-P) participant-rated questionnaire representing general cancer symptoms: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), and functional well-being (7 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-G score ranges from 0-108, with higher scores representing a better quality of life with fewer symptoms.

Full Information

NCT ID

NCT00642018

First Posted

February 28, 2008

Last Updated

March 11, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00642018

Brief Title

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

Official Title

A Randomized Phase 2 Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Hormone Refractory Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Hormone Refractory Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

154 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A: Docetaxel

Arm Type

Active Comparator

Arm Description

Standard of care (SOC) docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel therapy

Arm Title

B: LY2181308 + Docetaxel

Arm Type

Experimental

Arm Description

LY2181308 administered with docetaxel 75 mg/m² intravenously every 3 weeks and prednisone 5 mg orally twice daily continuously while receiving docetaxel

Intervention Type

Drug

Intervention Name(s)

docetaxel

Intervention Description

Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. 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.

Intervention Type

Drug

Intervention Name(s)

LY2181308 sodium

Intervention Description

LY2181308 sodium (referred to as LY2181308 throughout this record) 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.

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS) in Participants With Hormone Refractory Prostate Cancer (HRPC) Administered LY2181308 Sodium Plus Docetaxel Compared to Docetaxel Alone

Description

Time Frame

Baseline to measured progressive disease or death due to any cause up to 44.68 months

Title

Number of Participants With Adverse Events (Safety)

Description

Time Frame

First treatment dose up to 19 months

Secondary Outcome Measure Information:

Title

Adverse Event Profile

Description

Time Frame

First treatment dose up to 19 months

Title

Pharmacokinetics of Docetaxel: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-infinity)

Time Frame

Predose up to 8 hours postdose in Cycle 1

Title

Prostate Specific Antigen (PSA) Kinetics: Percentage of Participants With PSA Response (Response Rate)

Description

Time Frame

Baseline, 18 months

Title

Estimate Overall Survival

Description

Time Frame

First treatment to death due to any cause up to 45.54 months

Title

Estimate Duration of Overall Response

Description

Time Frame

Time of response to time of measured progressive disease up to 41.00 months

Title

Percentage of Participants With Complete Response or Partial Response (Overall Response Rate)

Description

Time Frame

Baseline to measured progressive disease up to 41.00 months

Title

Change From Baseline to Day 21 in Granulocyte Colony Stimulating Factor(G-CSF) (Assess Biomarker Responses)

Description

G-CSF [international units per milliliter (IU/mL)] was used to estimate biomarker responses and is presented as the percentage change from baseline.

Time Frame

Baseline, 21 days

Title

Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) Total Score at 3 Months (Participant Reported Outcomes)

Description

Time Frame

3 months

Title

Functional Assessment of Cancer Therapy-General (FACT-G) Total Score at 3 Months (Evaluate Clinical Symptoms)

Description

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

Number of Participants Who Died Due to Progressive Disease During the 30 Days Following Discontinuation From Study Treatment

Time Frame

Study treatment discontinuation up to 30 days post study treatment discontinuation

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

City

Augsburg

ZIP/Postal Code

86150

Country

Germany

Facility Name

City

Frankfurt

ZIP/Postal Code

60488

Country

Germany

Facility Name

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

City

Heidelberg

ZIP/Postal Code

69115

Country

Germany

Facility Name

City

Heilbronn

ZIP/Postal Code

D-74078

Country

Germany

Facility Name

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

City

Muenchen-Planegg

ZIP/Postal Code

82152

Country

Germany

Facility Name

City

Gdansk

ZIP/Postal Code

80-219

Country

Poland

Facility Name

City

Kielce

ZIP/Postal Code

25-734

Country

Poland

Facility Name

City

Olsztyn

ZIP/Postal Code

10-228

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

02-781

Country

Poland

Facility Name

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

City

Benidorm

ZIP/Postal Code

03501

Country

Spain

Facility Name

City

Elda

ZIP/Postal Code

03600

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

24722180

Citation

de Liano 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.

Results Reference

derived

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

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