None listed
Conditions
Interventions
Gemcitabine plus Carboplatin Type of group
Gemcitabine 1000 mg / m2 administered intravenously once a week for 2 weeks (day 1 and 8) followed by a week of rest. Carbopyatin will be administered on day 1, after Gemcitabine, at a dose compatible with a target AUC of 5 mg / mL.
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: Ovarian cancer histologically tested with evidence of recurrence or progression, which is not a tributary of curative surgery. Failure to first-line therapy with regimens containing Cisplatin, up to 6 months after the suspension of treatment (including patients with maintenance treatment.) The standard for first-line treatment in ovarian cancer chemotherapy is the combination of Cisplatin and Taxol derivatives. Prior homional therapy or radiotherapy (limited to the minor pelvis) should culminate 3 weeks before the administration of the study drug.
Exclusion criteria
Exclusion criteria: Concomitante u otro tratamiento antineoplastico concomitante. Se autoriza la terapia de reemplazo hormonal, siempre que se trate de esteroides antiemeticos La evidencia clinica de metastasis del sistema nervioso central (CNS) Infeccion activa (a criterio del investigador) Incapacidad para cumplir un seguimiento adecuado durante la duracion del estudio Una segunda neoplasia maligna primaria (salvo carcinoma cervical in situ o carcinoma de la piel de celula basa) adecuadamente tratado
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:• Study of the clinical history and physical examination, including the determination of height and weight. • Evaluation of the general state • Tumor measurement of palpable or visible lesions. Measurement CA-125. • Questionnaire EORTC QLQ-030 and OV28 QoL filled by the patient, which should not be repeated before the first cycle of therapy. Measure:To evaluate the response rate of the regimen in patients with Combatant plus Carboplatin, carrier of epithelial Ovarian Cancer primary refractory to Cisplatin or recurrent who failed primary therapy within the first 6 months after the initial episode was interrupted. Timepoints:6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Survival time Measure:Survival time Timepoints:throughout the study | — |
Countries
Peru
Outcome results
None listed