Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer

Trial ID or NCT#

NCT00988208

Status

not recruiting iconNOT RECRUITING

Purpose

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.

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Must sign an Informed Consent Form (ICF)2. Males ≥ 18 years of age3. Able to adhere to the study visit schedule and requirements of the protocol4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 25. Life expectancy of ≥ 12 weeks6. Willingness to participate in Patient-Reported Outcomes assessments7. Serum testosterone levels \< 50 ng/dL8. Confirmed metastatic adenocarcinoma of the prostate that is unresponsive or refractory to hormonal therapy9. 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 lesions10. Subjects must agree to receive counseling related to pregnancy precautions, teratogenic and other risks of lenalidomide11. Refrain from donating blood or semen as defined by protocol
Exclusion Criteria:
  1. 1. A history of clinically significant disease that places subject at an unacceptable risk for study entry2. Prior Therapy with thalidomide, lenalidomide or pomalidomide3. Prior chemotherapy for prostate cancer4. Use of any other experimental drug or therapy within 28 days prior to randomization5. Prior radiation to ≥ 30% of bone marrow or any radiation therapy within 28 days prior to randomization6. Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization7. Surgery within 28 days prior to randomization8. Concurrent anti-androgen therapy9. Abnormal serum chemistry or hematology laboratory values10. 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 213. History of severe hypersensitivity reaction to drugs formulated with polysorbate 8014. Paraplegia15. History of Central nervous system (CNS) or brain metastases16. History of malignancies other than prostate cancer within the past 5 years, with the exception of treated basal cell/squamous cell carcinoma of the skin17. Concurrent use of alternative cancer therapies
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Investigator(s)

Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

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Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov