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

Not Applicable

• 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

• Results First Posted: 1900-01-01
• Study Start: 2002-12-20
• Last Update Posted: 4 September 2023

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

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:• Study of the clinical history and physical examination, including the determination of height and weight.<br>• Evaluation of the general state<br>• Tumor measurement of palpable or visible lesions. Measurement CA-125.<br>• Questionnaire EORTC QLQ-030 and OV28 QoL filled by the patient, which should not be repeated before the first cycle of therapy.<br>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.<br>Timepoints:6 month<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Survival time<br>Measure:Survival time<br>Timepoints:throughout the study<br>