PHASE III RANDOMIZED STUDY COMPARING THE COMBINATION OF GEMCITABIN WITH CARBOPLATINE VERSUS THE CARBOPLATINE MONOTHERAPY, IN PATIENTS WITH ADVANCED EPITHELIAL OVARY CANCER WHOSE RESULTS WITH FIRST-LINE THERAPY WITH PLATINUM WERE NOT SATISFACTORY

Not Applicable

Completed

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

• Registration Number: PER-056-01
• Lead Sponsor: ELI LILLY INTERAMERICA INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08-07
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

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

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

• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified