Status:
TERMINATED
Lenalidomide and Paclitaxel in Prostate Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Celgene Corporation
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of Revlimid® (lenalidomide) that can be given in combination with paclitaxel to patients with prostat...
Detailed Description
Study Drugs: Lenalidomide is a drug that changes the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Taking lenalidomide could preve...
Eligibility Criteria
Inclusion
- Patients with metastatic adenocarcinoma of the prostate
- Patients in Phase II must have radiographic evidence of multiple (\>/= 2) or bulky (\>/= 5cm diameter) lymph node metastases with \< 2 bone (on radionuclide bone scan) discrete sites of involvement.
- Patient must have had front-line chemotherapy for castrate-resistant metastatic disease. Any number of prior chemotherapy regimens is permitted, except within the last 3 weeks. No prior thalidomide or lenalidomide therapy is permitted.
- Patients must have evidence of progression of disease based on any one of the following criteria: a) PSA- progression is defined as 2 consecutive increments in PSA (with an absolute change of at least 1ng/mL) over 4 weeks. b) An increase by 25% of the product of bi-dimensional disease or 30% in maximum diameter or appearance of an unequivocally new lesion qualifies as progression. c) Worsening symptoms clearly attributable to disease progression qualifies as progression e.g. worsening malignant bony pain.
- Patients on antiandrogens should be discontinued from flutamide, nilutamide or cyproterone acetate for at least 4 weeks and bicalutamide for 6 weeks. If progression is documented during or after this time interval, patients are eligible. Patients who have not had response to deferred (secondary) therapy with antiandrogens do not have to satisfy this waiting period prior to enrollment.
- Patients must have a performance status of \</= 2 (ECOG).
- Patients will not receive any concurrent biological, immunological, second-line hormonal therapy or chemotherapy. Patients receiving replacement or therapeutic doses of corticosteroid for non-malignant disease while disease progression was established may continue on such therapy.
- Patients must have recovered from prior chemotherapy, biological or immunological therapy or radiation delivered within the last 28 days. Radioisotope therapy with strontium delivered within the last 90 days or samarium within the last 60 days is not permitted.
- Patients must have a castrate serum testosterone level (\</= 50ng/ml) documented in the last six weeks. For patients who are medically castrated, luteinizing hormone releasing hormone analog must continue to maintain testicular suppression.
- Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of \>/= 1,500/mm\^3 and platelet count of \>/= 75,000/mm\^3.
- Patients must have adequate hepatic function defined with a bilirubin of \</= 2 X upper limits of normal and AST/ALT \</= 2.5 X the upper limits of normal.
- Patients must have adequate renal function defined as creatinine clearance \>/= 40 cc/min (measured or calculated by Cockcroft and Gault formula).
- Must be fully recovered from any previous surgery, in terms of wound healing.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
- Men must agree to use a latex condom during sexual contact with a female of childbearing potential (FCBP) even if they have had a successful vasectomy. A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Patient must be able to take low molecular weight heparin (preferred) OR low-dose enteric aspirin and warfarin for thromboembolic prophylaxis.
Exclusion
- Patients with severe or uncontrolled infection defined as symptomatic and/or requiring intravenous antibiotics.
- Patients with small cell or sarcomatoid variant of prostate cancer.
- Patients with symptomatic congestive heart failure (CHF), pulmonary embolus, vascular thrombosis, transient ischemic attack, cerebrovascular accident, unstable angina or MI in the last 3 months or evidence of active myocardial ischemia by symptoms or electrocardiogram (ECG).
- Known severe hypersensitivity to taxanes.
- Patients with central nervous system (CNS) metastasis or cord compression are excluded except those patients that have had complete excision or radiotherapy and remain asymptomatic for at least 2 months.
- Oxygen-dependent lung disease or \>/= grade 2 peripheral neuropathy.
- Known intolerance of corticosteroid therapy that would preclude its use as premedication for paclitaxel.
- Uncontrolled severe hypertension or uncontrolled diabetes mellitus.
- Active second malignancies. Non-threatening second malignancies such as superficial low-grade transitional cell carcinoma of the bladder or Rai Stage 0 chronic lymphocytic leukemia or stable small renal cell carcinomas may be exempt from such stipulation at the discretion of the Principal Investigator.
- Overt psychosis or mental disability or otherwise incompetent to give informed consent. Patients who are unwilling or unable to comply with the RevAssist® program or with a history of non-compliance with medical regimens or who are considered potentially unreliable.
- Patients with known HIV or active hepatitis A, B, or C infection.
- Patients receiving any concurrent biological, immunological, second-line hormonal therapy or chemotherapy. Patients receiving replacement or therapeutic doses of corticosteroid for non-malignant disease while disease progression was established may continue on such therapy.
- Patients who have not recovered from prior chemotherapy, biological or immunological therapy or radiation delivered within the last 28 days. Radioisotope therapy with strontium delivered within the last 90 days or samarium within the last 60 days is not permitted.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00933426
Start Date
August 1 2009
End Date
December 1 2015
Last Update
October 26 2016
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030