Trial Search Results
Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
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.
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
Celgene
Stanford Investigator(s):
Intervention(s):
- Drug: Lenalidomide
- Drug: Docetaxel
- Drug: Prednisone
- Drug: Placebo
Phase:
Phase 3
Eligibility
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
Male
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting