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
- Conditions
- -C56 Malignant neoplasm of ovaryMalignant neoplasm of ovaryC56
- Registration Number
- PER-056-01
- Lead Sponsor
- ELI LILLY INTERAMERICA INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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
• 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
- Primary Outcome Measures
Name Time Method <br>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.<br>Measure:Time to progression of the disease (TTPD) in patients treated with gemcitabine plus carboplatin versus carboplatin monotherapy.<br>Timepoints:6 months<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:A patient who responds to treatment will be defined as one that presents a GR, PR, or PRNM.<br>Measure:Response Index<br>Timepoints:6 months<br>;<br>Outcome name:The duration of the response is measured from the date of the first documented response to the date of disease progression.<br>Measure:Response duration<br>Timepoints:to the date of disease progression.<br>;<br>Outcome name:Survival is defined as the time from the date of randomization to the date of death from any cause.<br>Measure:Survival time<br>Timepoints:to the date of death from any cause.<br>;<br>Outcome name:Appearence of adverse events<br>Measure:Toxicity<br>Timepoints:When the adverse event appears<br>