COMPARATIVE STUDY OF PHASE II OF GEMCITABIN + PACLITAXEL IN PATIENTS WITH ADVANCED BREAST CANCER

ELI LILLY INTERAMERICA INC.,0 个研究点目标入组 0 人开始时间: 2000年8月11日最近更新: 2023年9月4日

适应症

试验速览

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•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.

•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.
•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.

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