None listed
Conditions
Interventions
Group A Type of group
1000 mg / m2 of gemcitabine given intravenously once a week for 2 weeks (day 1 and 8) followed by a week of rest. Carboplatin will be administered on day 1 after gemcitabine, which is consistent with a target AUC of 4 mg / mL min.
Group name:Group B Type of group
Carboplatin applied on day 1 every 3 weeks, consistent with a target AUC of 5 mg / mL min
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: • Histologically proven ovarian cancer with evidence of recurrence or progression, which can not be treated by curative surgery or radiotherapy • That you do not get good results from the therapy with platinum content after 6 months of the suspension of the treatment • Documented lesion using an adequate computerized axial tomography (CAT), magnetic resonance imaging (MRI), chest x-ray, or ultrasound. Physical examinations are allowed to rule out lymph nodes and skin metastases. Likewise, physical gynecological examinations of well-defined palpable tumor lesions are authorized. Patients must have a disease that can be evaluated outside the area previously irradiated. • Prior hormonal therapy or radiotherapy (limited to the minor pelvis) should end 3 weeks before the administration of the study drug. • Women> 18 years old • General status of O to 2 of the Scale of the Oncological Group of Eastern Cooperation (ECOG) • Approximate life expectancy of at least 12 weeks • Adequate bone marrow reserve ie: neutrophils> 1.5 x 10 6 / L and platelets> 100 x 10 6 / L • Ability to understand the nature of the study and grant authorization
Exclusion criteria
Exclusion criteria: • Reception of concomitant cytotoxic or other antineoplastic treatment. Hormone replacement therapy is authorized, as long as it is antiemetic steroids • Clinical evidence of central nervous system (CNS) metastasis • Active infection (at the discretion of the researcher) • You can not be followed properly during the duration of the study • A second primary malignancy (except cervical carcinoma in situ or adequately treated basal cell carcinoma) • Use of any research agent 3 weeks before inclusion • Serious concomitant systemic disorders incompatible with the study (at the discretion of the Investigator) • More than one prior chemotherapy regimen or previous treatment with gemcitabine • Patients with borderline malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The time that elapses until the progression of the disease is defined as the time from the date of the evaluation to the date of documented progression or death from any cause. Measure:Time to progression of the disease (TTPD) in patients treated with gemcitabine plus carboplatin versus carboplatin monotherapy. Timepoints:6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:A patient who responds to treatment will be defined as one that presents a GR, PR, or PRNM. Measure:Response Index Timepoints:6 months ; Outcome name:The duration of the response is measured from the date of the first documented response to the date of disease progression. Measure:Response duration Timepoints:to the date of disease progression. ; Outcome name:Survival is defined as the time from the date of randomization to the date of death from any cause. Measure:Survival time Timepoints:to the date of death from any cause. ; Outcome name:Appearence of adverse events Measure:Toxicity Timepoints:When the adverse event appears | — |
Outcome results
None listed