None listed
Conditions
Interventions
Group 1 Type of group
2000 mg / m2 IV in repeated courses: 3 weeks of therapy and 1 week of rest
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: • 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 ( 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).
Exclusion criteria
Exclusion criteria: • 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurable malignant disease (decimal metric system) in two dimensions by ruler or compass with the defined surface area by multiplying the largest diameter by the largest perpendicular diameter (ie, metastatic pulmonary nodules, lymph nodes, and subcutaneous masses). Malignant disease with well-defined edges of at least 1 cm x 1 cm, measurably two-dimensionally, observable by X-rays, photography or tracking (such as computerized axial tomography or magnetic resonance imaging) will be considered measurable. Lesions evaluated only with a radionuclide scan will not be considered measurable. Bone lesions will not be considered measurable. Measure:Efficacy Timepoints:During control visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• Complete PSA response: PSA normalization ( 50% (without normalization) in PSA in two successive evaluations with at least four weeks apart. Stable AEP Response: The decrease does not meet the criteria for an RC, RP or EP PSA. • Progressive AEP: For patients who have experienced less than 50% improvement Measure:Prostate Specific Antigen Timepoints:The evaluation of the AEP> 4 weeks of the assessment of the initial AEP ; Outcome name:An adverse event is any unwanted medical alteration that occurs in a patient within a research study, which is administered a drug or any biological product (medical product) or using a medical procedure, the events do not necessarily have a causal relationship with the treatment or its use. Measure:Safety Timepoints:During the study | — |
Outcome results
None listed