PER-056-01已完成未知
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
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
研究者
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