None listed
Conditions
Interventions
On Day 1, paclitaxel (175 mg / m2) administered intravenously for approximately 3 hours followed by gemcitabine (1250 mg / m2). Administered as an intravenous infusion for 30 minutes (maximum infusion time: 60 minutes). On Day 8, gemcitabine (1250 mg / m2) administered as an intravenous infusion for 30 minutes (maximum infusion time: 60 minutes).
Group name:Arm B Type of group
Single agent paclitaxel 175 mg / m2 administered intravenously for approximately 3 hours on Day 1 every 21 days.
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients will have histological or cytological diagnosis that evidences unresectable, locally advanced or metastatic disease. Injuries should not be subject to surgery or radiation with healing intentions. • Women at least 18 years of age. • Patients who have relapsed after [a] receiving adjuvant / neoadjuvant chemotherapy with anthracycline, unless [b] is clinically contraindicated. • Treatment with humanized anit-HER2 antibody is allowed. • Clinically measurable disease defined as two-dimensionally measurable lesions with clear margins defined by imaging studies or physical examination. Ultrasound is not an acceptable method to document tumor measurements for this study. An indicator of injury that serves as measurable disease should be at least 1 cm by 1 cm, as defined by computerized tomography (CT) scan, magnetic resonance imaging (MRI), or x-ray, or at least less 2 cm by 2 cm defined by a physical examination. • Measurable disease that is outside a previously irradiated area. • Radiation must end at least 2 weeks prior to enrollment. Patients must have recovered from the toxic effects of previous therapy. • Activity status from 79 to more on the Karnofsky Scale • Estimated Life Expectancy for at least 12 weeks • Adequate reserve of bone marrow: Absolute granulocyte count (AGC)> 1.5 x 10 6 / L, platelets> 100 x 10 6 / L, and hemoglobin> 9.0 g / dL. • Adequate liver function (bilirubin <1.5 times the normal limit [ULN], alanine transaminase (ALT) and aspartate transaminase ASI <2 times ULN (Venook et al., 1998). • Calcium <1.2 times ULN. • Adequate renal function (creatinine <1.5 times ULN). • Antitumor hormone treatment terminated prior to enrollment (until the day of randomization). • Bisphophonated therapy is allowed, however, therapy can not stop or start within 4 weeks prior to enrollment. • Patient compliance and geographic proximity that allows adequate follow-up. • Informed Consent signed by the patient. • Women with reproductive potential should use an approved contraceptive method (eg, intrauterine device [IUD], birth control pills or barrier device) during and for 3 months after the study.
Exclusion criteria
Exclusion criteria: • Previous therapy with gemcitabine or a taxane. • Previous chemotherapy for metastatic cancer to the breast. • Inflammatory breast cancer without evidence of metastatic disease. • Active heart disease not controlled by therapy and / or myocardial infarction within the preceding 6 months. • Knowledge or suspicion of metastasis / recurrence to the brain that requires treatment with steroids or radiation. • Active infection (at the investigator´s discretion). • Serious concomitant seismic disorders including uncontrolled diabetes mellitus) incompatible with the study (at the discretion of the investigator). • Second primary neoplasia (except carcinoma in situ cervix or basal cell carcinoma to adequately treated skin or squamous cell carcinoma to the skin without relapse for 5 previous years). • Bone metastasis, pleural effusions, or ascites as the sole focus of disease. • Bone marrow transplant or autologous cell stem infusion followed by high dose chemotherapy for adjuvant or metastatic disease. • Radiation greater than 20% of total bone marrow producing areas • Concurrent administration of radiation therapy, chemotherapy, hormonal therapy or immunotherapy (including humanized HER2 antibody). • History of hypersensitive reactions with drugs formulated in Cremophor EL (polyoxyethylated castor oil). • Treatment with a drug within the last 30 days that has not received regulatory approval at the time of entry to the study. • Presence of severe psychiatric illness. • Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Total survival time is defined as the time from the date of randomization to the time of death from any cause. Survival time will be counted on the date of the last follow-up post-therapy visit for those patients who are still alive. Measure:Total survival time Timepoints:to the time of death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The time of the documented progression of the disease is defined as the time between the randomization date and the date of the first day of evaluation of the progression of the disease from any cause. The time that elapses until the progression of the disease is evaluated will be counted on the date of the last post-treatment follow-up visit for patients who are still alive and who have not evaluated the progression of the disease. Measure:The time of the documented progression of the disease Timepoints:date of the first day of evaluation of the progression of the disease from any cause. ; Outcome name:The time of survival free progression is defined as the time between the date of randomization and the first date that the progression of the disease is evaluated by any cause. The time of free progression of survival will be counted on the date of the last follow-up visit post therapy for patients who remain alive and who have not evaluated the progression of the disease. Measure:The time of survival free progression Timepoints:the first date that the progression of the disease is evaluated by any cause. ; Outcome name:Safety will be evaluated through adverse clinical events, laboratory tests (CTC) and non-laboratory toxicities Measure:Safety Timepoints:When the adverse event happens | — |
Outcome results
None listed