None listed
Conditions
Interventions
FEM Type of group
2000 mg / m2 of FEM administered as an intravenous infusion
during 60 minutes via a central venous catheter in processes consisting of: Administration once a week for 3 weeks followed by a week of rest, this process will be repeated 3 times per cycle.
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: • Adult Men with a histologically proven diagnosis of metastatic prostate cancer. • Patients who have progressed in hormone therapy. Patients on LHRH therapy should continue with it. • Patients must have a CDMM of> 2 if they are not on analgesic medication or> 1 if they are receiving analgesic medication. • Patients should have castrate testosterone levels ( 18 years of age. • Patients should have a sufficient stock of bone marrow indicated by granulocyte count greater than or equal to 1500 / mm3, and platelet counts of> 100,000 / mm3 • Patients should have adequate renal and hepatic function: creatinine 3 months. • 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: • Adult Men with a histologically proven diagnosis of metastatic prostate cancer. • Patients who have progressed in hormone therapy. Patients on LHRH therapy should continue with it. • Patients must have a CDMM of> 2 if they are not on analgesic medication or> 1 if they are receiving analgesic medication. • Patients should have castrate testosterone levels ( 18 years of age. • Patients should have a sufficient stock of bone marrow indicated by granulocyte count greater than or equal to 1500 / mm3, and platelet counts of> 100,000 / mm3 • Patients should have adequate renal and hepatic function: creatinine 3 months. • 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:McGill-Melzack Pain Scale Questionnaire (CDMM). The percentage of patients exhibiting a decrease in pain without an increase in analgesics during the period of the first twelve weeks. The pain reduction will be evaluated as a reduction of 2 points or complete loss of pain, if the pain was initially classified as 1, on the pain intensity scale Measure:Clinical Efficacy Timepoints:On the last visit ; Outcome name:Measurement of the specific prostate antigen. Measure:Laboratorial Efficacy Timepoints:Will be measured on the first visit and on all of the weeks of treatment | — |
Outcome results
None listed