Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments lenalidomide, docetaxel, prednisone, placebo
Phase phase 3
Sponsor Celgene Corporation
Start date November 2009
End date January 2012
Trial size 1059 participants
Trial identifier NCT00988208, CC-5013-PC-002, EudraCT Number 2008-007969-23

Summary

The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer.

The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
25 mg lenalidomide orally once each day on Days 1-14; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice daily on each day of the treatment cycle
lenalidomide CC-5013
25 mg lenalidomide orally once each day on Days 1-14
docetaxel Taxotere
75 mg/m2 intravenous docetaxel on Day 1
prednisone There are multiple brand names for prednisone.
5 mg prednisone orally twice daily on each day of the treatment cycle
(Experimental)
Oral placebo once each day on Days 1-14 of the treatment cycle; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice each day on each day of the treatment cycle
docetaxel Taxotere
75 mg/m2 intravenous docetaxel on Day 1
prednisone There are multiple brand names for prednisone.
5 mg prednisone orally twice daily on each day of the treatment cycle
placebo
Oral placebo once each day on Days 1-14 of the treatment cycle

Primary Outcomes

Measure
Overall Survival (OS)
time frame: Randomization until death from any cause up to the cut-off date of 13 January 2012

Secondary Outcomes

Measure
Progression-free Survival (PFS)
time frame: Randomization until disease progression or death from any cause up to cut-off date of 13 Jan 2012; maximum time on study approximately 26 months
Objective Response Rate (ORR) of Measurable and/or Non-measurable Disease as Determined by Investigators According to RECIST Version 1.1 Criteria
time frame: Day 1 to data cut-off 13 January 2012; maximum time on study approximately 26 months
Number of Participants With Treatment Emergent Adverse Events (AEs)
time frame: The maximum duration on study drug was 93 weeks, which includes the time from the first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut-off date of 13 January 2012

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: 1. Must sign an Informed Consent Form (ICF) 2. Males ≥ 18 years of age 3. Able to adhere to the study visit schedule and requirements of the protocol 4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 5. Life expectancy of ≥ 12 weeks 6. Willingness to participate in Patient-Reported Outcomes assessments 7. Serum testosterone levels < 50 ng/dL 8. Confirmed metastatic adenocarcinoma of the prostate that is unresponsive or refractory to hormonal therapy 9. Have documented disease progression while receiving or following hormonal therapy as determined by increasing Serum Prostate Specific Antigen (PSA) level, Radiological Progression, or ≥2 new bone lesions 10. Subjects must agree to receive counseling related to pregnancy precautions, teratogenic and other risks of lenalidomide 11. Refrain from donating blood or semen as defined by protocol Exclusion Criteria: 1. A history of clinically significant disease that places subject at an unacceptable risk for study entry 2. Prior Therapy with thalidomide, lenalidomide or pomalidomide 3. Prior chemotherapy for prostate cancer 4. Use of any other experimental drug or therapy within 28 days prior to randomization 5. Prior radiation to ≥ 30% of bone marrow or any radiation therapy within 28 days prior to randomization 6. Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization 7. Surgery within 28 days prior to randomization 8. Concurrent anti-androgen therapy 9. Abnormal serum chemistry or hematology laboratory values 10. Significant active cardiac disease within the previous 6 months: 11. Thrombotic or thromboembolic events within the past 6 months: 12. History of peripheral neuropathy of ≥grade 2 13. History of severe hypersensitivity reaction to drugs formulated with polysorbate 80 14. Paraplegia 15. History of Central nervous system (CNS) or brain metastases 16. History of malignancies other than prostate cancer within the past 5 years, with the exception of treated basal cell/squamous cell carcinoma of the skin 17. Concurrent use of alternative cancer therapies

Additional Information

Official title A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone With or Without Lenalidomide in Subjects With Castrate-Resistant Prostate Cancer (CRPC)
Description In November 2011, the Data Monitoring Committee concluded it was unlikely that the study would meet its primary endpoint of overall survival (OS) and recommended that the study be stopped. The study was terminated in accordance with this recommendation. All sites were instructed to immediately discontinue all patients from experimental lenalidomide/placebo treatment administered either in combination with chemotherapy or as a single agent following chemotherapy discontinuation. Subsequently, Protocol Amendment 3 was issued to provide for the following: To continue to collect information on Second Primary Malignancies (SPMs) and additional treatments for Prostate Cancer in all randomized subjects during survival follow-up. To continue to provide docetaxel and prednisone for up to 10 cycles to subjects randomized at non-US sites who were ongoing in the CC-5013-PC-002 protocol when the decision was made to discontinue lenalidomide/placebo and who were experiencing benefit as per investigator discretion. For subjects who had exceeded 10 cycles of docetaxel and prednisone at the time of Protocol Amendment 3 approval, an additional two cycles were provided. All references to dosing and study procedures pertaining to the safety, efficacy, and exploratory endpoints of lenalidomide/placebo were discontinued as part of Protocol Amendment 3.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Celgene Corporation.