Phase II Evaluation of the Efficacy and Safety of Intravenous Estramustine Phosphate in Patients with Measurable Metastatic Cancer of Hormone Refractory Prostate.
- Conditions
- -C61 Malignant neoplasm of prostateMalignant neoplasm of prostateC61
- Registration Number
- PER-034-00
- Lead Sponsor
- PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Adult Men with a histopathologically proven diagnosis of prostate cancer.
• Measurable disease, bidimentionally at least 1cm x 1cm.
• Patients who have progressed in hormone therapy, ex. either they have an increase in the size of a new measurable lesion, a new lesion in a bone scan or a> 50% increase in AEP for a minimum of 5 ng / mL. Patients on LEIRH therapy should continue with it.
• Patients should have castrate testosterone levels (<1,735 mmoL / L or <50 ng / dL).
• Acute toxic effects (excluding alopecia) due to previous therapies should be classified as grade <1 in the Common Toxicity Criteria, National Cancer Institute.
• A central venous catheter must be applied before starting the therapy under study.
• Patients must be> 18 years of age.
• Patients must have an ECOG performance status of O, 1, or 2.
• Patients should have an expected survival of> 3 months.
• Patients must have a sufficient reserve of bone marrow indicated by the granulocyte count greater than or equal to 1500 / mm3, and platelets count> 100,000 / mm3
• Patients should have adequate renal function: creatinine <1.5 mg / dL,
• Patients should have adequate liver function with total bilirubin <1.5 mg / dL, transaminase (TSGO) <3 x the upper normal limit.
• Each patient must be fully aware of the nature of the disease process and give their consent willingly after being informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks and discomfort with therapy and placement of a central venous catheter (Informed Consent).
• Patients who have received more than one prior chemotherapy
• Patients who have received previous therapy with estramustine phosphate.
• Patients who have received therapy with high doses of estrogen in the last year.
• Patients who have received radioisotopes during the past 90 days
• Patients with <4 weeks since treatment with flutamide, nilutamide, or <6 weeks since treatment with bicalutamide has been discontinued. If a withdrawal syndrome is observed, ex. a 50% decrease in AEP, then the patient can not be included until the AEP has risen again 50% or to> 5 ng / mL.
• Patients with <1 week of previous surgery (excluding minimal procedures such as insertion of a vascular access device).
• Patients with a previous history of profuse venous thrombosis and / or pulmonary embolism, coagulation disorders.
• Patients with active angina, including stable angina or unstable angina.
• Patients with a history of myocardial infarction, congestive heart failure, temporary ischemic attack or stroke within the last 6 months.
• Known leptomeningeal disease (it will be CT, I RM, brain, in case of clinical suspicion of alaterations in the central nervous system).
• Patients with concomitant infections including known HIV infection
• Patients with other cancers except skin melanoma not treated properly.
• Patients with other severe concurrent diseases that make the patient´s judgment inappropriate to participate in this study.
• Patients with mental or psychiatric disability that interfere with the ability to give the consent report or complete visits.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method