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| Sponsors and Collaborators: |
Oncology Specialists, S.C. Celgene Corporation |
|---|---|
| Information provided by: | Oncology Specialists, S.C. |
| ClinicalTrials.gov Identifier: | NCT00654186 |
Purpose
This is a single institution, open label, phase II study in androgen-independent prostate cancer patients who are chemotherapy-naïve. Patients will receive Revlimid® 25 mg daily on Days 1-21 followed by 7 days of rest repeated every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Revlimid |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | A Phase II Study Evaluating the Toxicity and Efficacy of Single Agent Lenalidomide (Revlimid®) in Chemotherapy-Naïve Androgen-Independent Prostate Cancer Patients |
| Estimated Enrollment: | 25 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Revlimid
25mg daily on days 1 - 21 followed by 7 days of rest repeated every 28 days
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients should be considered hormone refractory and androgen independent. They must fail LHRH analogues, and anti-androgen withdrawal trial.
Failure is confirmed by an increase in PSA value of 10% or more than the value immediately before, and confirmed by another assessment 2 weeks later that shows a further increase.
Patients need to have adequate bone marrow function.
Exclusion Criteria:
Contacts and Locations| Contact: Kathy Tolzien, RN | 847-410-0658 | ktolzien@oncmed.net |
| Contact: Phillip Gozun | 847-410-0662 | pgozun@oncmed.net |
| United States, Illinois | |
| Oncology Specialists, S.C | Recruiting |
| Niles, Illinois, United States, 60714 | |
| Contact: Kathy Tolzien, RN 847-410-0658 ktolzien@oncmed.net | |
| Principal Investigator: | Chadi Nabhan, MD | Oncology Specialists, SC |
More Information
| Responsible Party: | Oncology Specialists, S.C ( Chadi Nabhan, MD ) |
| Study ID Numbers: | RV-PCA-PI-327 |
| Study First Received: | April 2, 2008 |
| Last Updated: | April 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00654186 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Androgen Independent Prostate Cancer (AIPC) Chemo naive |
|
Prostatic Diseases Genital Neoplasms, Male Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Lenalidomide |
Urogenital Neoplasms Genital Diseases, Male Hormones Prostatic Neoplasms Androgens |
|
Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Lenalidomide Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Genital Diseases, Male |
Hormones Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms Androgens |