None listed
Conditions
Interventions
Gemcitabine + Paclitaxel Type of group
Gemcitabine will be administered on Days 1 and 8 of each cycle. Paclitaxel will be administered on day 1 of the cycle. 1200 mg / m2 of gemcitabine will be administered intravenously for 30 to 60 minutes, and Paclitaxel 175 mg / m2 intravenously in a 3-hour infusion. In addition 50 mg of Benadryl IV will be administered 30 minutes before the infusion of Paclitaxel. Dexamethasone (20 mg) will be administered orally 6 and 12 hours before Paclitaxel. The cycles will be repeated every 21 days, accord
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: • Histological or cytological diagnosis of breast carcinoma. • Two-dimensionally measurable advanced and / or metastatic disease. • Patients may have received adjuvant with anthracyclines, but should not have received chemotherapy treatment for advanced disease. • They may have received multiple lines of hormone treatment. • Prior radiotherapy allowed provided that the irradiated area is not the only source of measurement of the disease. • Activity level from 0 to 2 on the Zubrod scale • Performance Status 0 or 1 on the Zubrod Performance Scale). • Adequate adequate bone marrow reserve: leukocyte count (WBC)> 3000 X 10 6 / L, platelets> 100,000 x 10 6 / L and hemoglobin> 10g / dL • Calcium within 10% of normal limits. • Expected life expectancy of at least 12 weeks. • Patient compliance and geographical proximity that allow adequate follow-up. • Patient´s duly signed Informed Consent. • Written informed consent of the patient. • Age> 21 years. • If patient is of childbearing age,pregnancy prevention measures should be used.
Exclusion criteria
Exclusion criteria: • For at least 4 weeks before the start of the study, no other form of antineoplastic treatment such as neoadjuvant chemotherapy or radiation has been received. Patients must have recovered from any significant toxicity associated with the most recent treatment. • Hepatic insufficiency: bilirubin 2.0 times higher than normal; ALT / AST 3 times above the normal maximum limit. • Renal insufficiency: creatinine 2 times higher than normal. • Pregnancy or the absence of birth control methods during the study. •Lactation • Active heart disease requiring treatment for insufficiency, angina and / or arrhythmias; infarcts during the previous 6 months (exception: any patient whose heart failure is compensated with medication). • Severe pulmonary disease or significant peripheral vascular disease. • Significant neurological (such as seizures) or psychiatric disorders. • Bone metastatic disease (with the exception of pure lesions greater than or equal to 2 cm in diameter clearly visible and measurable in simple Rx), pleural effusion or ascites as the only manifestation of the disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Tumor measurement Measure:Efficacy Timepoints:Tumor measurements should be made before the start of treatment and before the third cycle. From the third cycle, measurements must be made every other cycle. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Any severe adverse effects related to the use of the drugs must be reported immediately by fax through the Adverse Effects of the Study Information Form. Measure:Safety Timepoints:Patients will be questioned at least once before each cycle regarding the appearance and the nature of any adverse effects during the elapsed cycle. | — |
Countries
Argentina, Chile, Peru
Outcome results
None listed