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
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- Maximum tolerated dose (MTD) of lenalidomide
Overview
Brief Summary
Primary objectives:
To determine the maximum tolerated doses (MTDs) of daily lenalidomide and docetaxel given every three weeks and prednisone, as combination therapy to subjects with androgen independent prostate cancer
To evaluate the safety profile of the combination of daily lenalidomide and every three week docetaxel and prednisone when given to subjects with androgen independent prostate cancer
Secondary objective:
To explore the anti-tumor activity of the combination of daily lenalidomide and every 3 week docetaxel and prednisone when given to subjects with androgen independent prostate cancer.
Detailed Description
Adenocarcinoma of the prostate is the second leading cause of cancer death in men. There is medication available to help treat this disease, which typically lengthens life by 10 to 12 months. More recent studies have shown average survivals of 20 to 23 months.
The investigators hope that the experimental (research) drug called lenalidomide (Revlimid®), which is being used in this study, will lengthen the lives of these patients by even more time. A different drug in the same drug family has demonstrated activity against a variety of solid tumors as well as hematological malignances. It works against cancer in different ways than chemotherapy by affecting the immune system (the body's ability to naturally fight disease).
The investigators believe that the study drug helps build up patients' immune systems than some of the other popular drugs on the market, and may potentially increase survival rates for patients with hormone refractory prostate cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects must understand and voluntarily sign an informed consent document.
- •Age \> 18 years at the time of signing informed consent form.
- •Histological documentation of prostate cancer.
- •Subjects must be able to adhere to the study visit schedule and other protocol requirements.
- •Radiographic or clinical evidence of measurable or evaluable androgen independent prostate cancer stages D1 or D
- •Patients must be surgically or medically castrated. If the method is medical castration, the patient must have a serum testosterone level of \<50 ng/dl/. The patient should maintain treatment with LH RH antagonists or agonists.
- •Patients must have metastatic prostate cancer unresponsive or refractory to androgen blockade by one or more of the following criteria:
- •Progression of unidimensionally measurable disease.
- •Progression of non measurable disease
- •Rising PSA (absolute value of PSA \> 5 mg/ml).
Exclusion Criteria
- •Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent.
- •More than 2 prior regimens of chemotherapy.
- •Use of thalidomide or biologic response modifier therapy within 28 days of initiation of therapy
- •Prior desquamating rash while taking thalidomide therapy.
- •Prior \> grade-2 allergic reaction to thalidomide.
- •Any prior use of lenalidomide. Subjects may have received prior thalidomide therapy.
- •Concurrent use of any other anti-cancer agents, excluding bisphosphonates.
- •Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in case of clinical suspicion of central nervous system involvement).
- •Active infection, known positive for HIV or hepatitis B or C.
- •Known hypersensitivity or intolerance to taxanes or polysorbate
Arms & Interventions
Lenalidomide, Docetaxel, Prednisone
Subjects will receive this drug combination during a treatment phase and an extension phase.
Intervention: Lenalidomide (Drug)
Lenalidomide, Docetaxel, Prednisone
Subjects will receive this drug combination during a treatment phase and an extension phase.
Intervention: Docetaxel (Drug)
Lenalidomide, Docetaxel, Prednisone
Subjects will receive this drug combination during a treatment phase and an extension phase.
Intervention: Prednisone (Drug)
Outcomes
Primary Outcomes
Maximum tolerated dose (MTD) of lenalidomide
Time Frame: Up to 2 years
The MTDs of lenalidomide, docetaxel and prednisone when given as combination therapy will be defined as the highest dose level at which no more than 1 out of 6 subjects experiences Dose Limiting Toxicity (DLT).
Secondary Outcomes
No secondary outcomes reported