PHASE II STUDY: COMBINATION OF GEMCITABIN WITH CARBOPLATIN IN PATIENTS WITH REFERENCED OR RECURRENT ADVANCED EPITHELIAL OVARY CANCER

Not Applicable

Completed

• Conditions: C56; -C56 Malignant neoplasm of ovary; Malignant neoplasm of ovary

• Registration Number: PER-080-02
• Lead Sponsor: ELI LILLY INTERAMERICA INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12-20
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified