Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile of Lenalidomide (Revlimid® CC-5013) With Every Three Week Docetaxel (Taxotere®) In Subjects With Androgen Independent Prostate Cancer
Adenocarcinoma of the prostate is the second leading cause of cancer death in men. Despite
rapid and often dramatic responses to androgen blockade, nearly all patients with metastatic
prostate cancer will develop androgen independent progression.(1) Unfortunately, to date no
single agent or combination therapy has been demonstrated to improve survival in patients
with metastatic androgen independent prostate cancer. The current standard of care, the
combination of mitoxantrone with corticosteroids, is palliative, and treatment with this
combination results in median survivals of 10 to 12 months. More recently, phase 2 studies
of docetaxel, either as a single agent or in combination with estramustine, demonstrated
median survivals of 20 to 23 months. Although docetaxel based therapy can potentially
increase the median survival from 12 to 20 months, new agents need to be identified to
further extend survival.
Lenalidomide is a member of a class of pharmaceutical compounds known as immunomodulatory
drugs (IMiDs™). The first clinically available IMiD, thalidomide (Thalomide), has
demonstrated activity against a variety of solid tumors as well as hematological
malignances. A potentially greater potency to activate immunomodulatory effects is a major
advantage of lenalidomide compared to thalidomide. Three in vitro studies have been
performed to compare the activity and potency of lenalidomide and thalidomide. Two studies
examined the effects of lenalidomide or thalidomide on the production of various cytokines
and the other examined effects on multiple myeloma cell proliferation. In all studies,
lenalidomide was approximately 50 to 2000 times more potent than thalidomide.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of lenalidomide and docetaxel given every three weeks with prednisone
Until disease progression
Yes
Daniel P Petrylak, MD
Principal Investigator
Columbia University
United States: Food and Drug Administration
AAAB3212
NCT01378091
August 2005
November 2012
Name | Location |
---|---|
Columbia University Medical Center | New York, New York 10032 |
Cornell Weill Medical Center | New York, New York 10065 |