None listed
Conditions
Interventions
ALIMTA Type of group
Infusion of 500 mg / m2 IV daily
A cycle is defined as a 21-day interval (a cycle delay due to holidays, weekends and bad weather will be allowed and will not be considered a protocol violation). A cycle includes an ALIMTA treatment on Day 1. The actual dose to be administered will be determined by calculating the body surface area (SC) at the beginning of each cycle.
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: • Suspected or confirmed breast cancer (the diagnosis must be confirmed before the first administration of ALIMTA). The disease will be classified as T3 or T4 and NO, NI, or N2. • The condition of the disease must be that measurable disease defined as: Two-dimensionally measurable lesions with clear margins defined by any of the following: o Computed tomography (CT), magnetic resonance imaging (MRI) or other image scans (except bone scan) with both diameters greater than the distance between the slices of the imaging study. or palpation, with both diameters greater than or equal to 2 cm, together with an adequate imaging procedure. • 70 to more activity status in the Kamofsky Scale. • Estimated Life Expectancy of at least 12 weeks. • Suitability of the patient and geographical proximity that allows an appropriate follow-up. • Adequate functioning of the organ, including the following: o Adequate reserve of bone marrow: absolute neutrophil count (segmented abraded), Absolute Neutrophil Count (ANC)> 1.5 X 10 9 / L, platelets> 100 x 10 9 / L, and hemoglobin> 9 g / dL. or Hepatic: bilirubin 45 mL / min using only the body mass formula (Cockcroft and Gault) • Informed Consent signed by the patient. • Women at least 18 years of age. • Patients with reproductive potential should use a contraceptive method if necessary (for example, intrauterine device [IUD], or barrier device) during and for 3 months after the study. Oral contraceptives should be discontinued at least 3 weeks before the enrollment, and not used during study therapy. • Patients must be able to tolerate surgical procedures according to the recommendation of their doctors and descriptions of this protocol.
Exclusion criteria
Exclusion criteria: • Treatment with any drug in the last 30 days that has not received regulatory approval at the time of entering the study. • Any previous or concomitant antitumor therapy (such as cytotoxic, hormonal, or radiotherapy)). • Patients must have discontinued the use of any steroid medication no less than 3 weeks prior to enrollment. • Pregnancy or breastfeeding. • Serious concomitant systemic disorders, including active infection that could compromise patient safety or the patient´s ability to complete the study, at the discretion of the investigator. • Second primary neoplasm (except in situ carcinoma of the cervix or carcinoma to the non-melanoma skin adequately treated or another neoplasm treated at least 5 years previously, without evidence of relapse). • Inability to discontinue aspirin or other non-steroidal anti-inflammatory agents 2 days before, the day of, or two days after the dose of ALIMTA (5 days before for long-acting agents such as piroxicam) • Presence of clinically detectable fluid collection (by physical examination); for example, ascites or pleural effusions (collection of fluids may be by drainage to allow the patient to enroll in the study). • Significant weight loss (for example,> 10%). if known, in the last 6 weeks before entering the study. • Inability to take folic acid or Vitamin B12 supplement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Physical exam, Tumor measurement (visible or palpable), radiological tests for tumor measurements, biochemistry and hematology tests Measure:The correlation between expression levels of TS, DHFR, GARPT, p53 and erbB2, in breast cancer and normal tissues, and the patients response to ALIMTA therapy. Timepoints:Within 10 days of enrollment in the study, then +3 days on Day 8, within 4 days before each cycle, and if possible in the poststudy visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Tumor measurement (visible or palpable), Radiological tests for tumor measurements Measure:Tumor response rate of advanced breast cancer patients who have not been previously treated after receiving 3 cycles of ALIMTA (LY231514) Timepoints:It is repeated before each cycle, and before surgery ; Outcome name:Biochemical tests (homocysteinic and methylmalonic acid), Physical exam. Measure:The impact of a patients nutritional status on safety and efficacy, as measured before treatment by homocysteinic and methylmalonic acid levels Timepoints:Within 10 days of enrollment in the study, then ± 3 days on Days 8 and 15 as indicated, within 4 days before each cycle, and if possible in the post-study visit ; Outcome name:Biochemical tests (TS, DHFR, GARFT, p53 and erbB2) Measure:Levels of TS, DHFR, GARFT, p53 and erbB2, in breast cancer and normal tissues Timepoints:Within 10 days of enrollment in the study, then ± 3 days on Day 8, within 4 days before each cycle, and if possible in the post-study visit | — |
Outcome results
None listed