EUCTR2004-000722-69-ES进行中（未招募）不适用
A PHASE II, RANDOMIZED STUDY OF CARBOPLATIN-GEMCITABINE PLUS CARBOPLATIN-PACLITAXEL VERSUS CARBOPLATIN-PACLITAXEL IN PLATINUM-SENSITIVE PATIENTS WITH RECURRENT OVARIAN CARCINOMA, PRIMARY PERITONEAL CARCINOMA OR FALLOPIAN TUBE CANCER.
Grupo Español de Investigación en Cáncer de Ovario (GEICO)0 个研究点开始时间: 2004年9月16日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Recurrent ovarian epithelial cancer, primary peritoneal carcinoma or fallopian tube cancer histologically tested and previously treated.
- •Maximum 2 lines of previous treatment.
- •The last line of treatment received by the patient should include a platinum compound (cisplatin or carboplatin) and meet the sensitive-platinum criteria according to Thigpen´s definition (Platinum-sensitive patients are those who obtain an initial response to a platinum treatment and present a platinum-free interval > 6 months. We consider platinum-free interval treatment the time elapsed since the last cycle with platinum and the recurrent or progression date).
- •Patients should have received a taxane (docetaxel or paclitaxel) in any of the prior treatment lines.
- •Presence of unidimensionally measurable and/or valuable illness according to Rustin´s CA-125 response criteria (see 8.b.1.1. clinical response valuation).
- •Patients older than 18 years
- •Functional performance status < or = 2 by ECOG scale
- •Life expectancy higher than 12 weeks
- •Adequate renal, hepatic and haematological function defined by any of the following criteria.
- •- Creatinine clearance > or = 40 ml/min
- •- Bilirubin no greater than 1,5 times upper limit of normal (ULN)
- •- SGOT no greater than 2,5 times ULN (In case of metastases no greater than
- •5 times upper limit of normal).
- •- Prothrombin time test> 50%
- •- Hemoglobin > 10 mg/dL
- •- Platelets > 100.000 / mm3
- •- Neutrophils > 2000 / mm3
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with recurrent ovarian cancer considered platinum-resistant according to Thipgen´s criteria (progression, with no response with platinum-based drug treatment or recurrence within 6 months after a platinum treatment).
- •Patients who have received more than two lines of prior treatments.
- •Patients who have not received a platinum compound drug during the last chemotherapy line.
- •Patients who have not received a prior taxane therapy.
- •Patients who have received prior gemcitabine treatment.
- •Non-measurable or valuable illness according to Rustin´s criteria.
- •Active infection or another serious medical condition that in investigator´s opinion could interfere with the study´s development.
- •Central nervous system metastases.
- •Patients who does not present an adequate hepatic, renal or haematological function according to the previously defined criteria.
- •Patients with a history of another neoplasia except carcinoma in situ of the cervix properly treated, or basal cell carcinoma properly treated.
- •Pregnant women, nursing mothers or women of childbearing potential not practicing adequate means of contraception.
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