EUCTR2006-006950-81-DE进行中（未招募）1 期
A PHASE 3 STUDY OF SAFETY AND EFFICACY OF KARENITECIN VERSUS TOPOTECAN ADMINISTERED FOR 5 CONSECUTIVE DAYS EVERY 3 WEEKS IN PATIENTS WITH ADVANCED EPITHELIAL OVARIAN CANCER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- •1. Age = 18 years.
- •2. Documented histopathological or cytological diagnosis of stage III or IV epithelial ovarian cancer as defined by the International Federation of Gynecology and Obstetrics (FIGO) (Appendix D of the protocol).
- •3. The following tumor histological epithelial cell types will be accepted:
- •Serous adenocarcinoma
- •Endometrioid adenocarcinoma
- •Mucinous adenocarcinoma
- •Undifferentiated carcinoma
- •Clear cell adenocarcinoma
- •Mixed epithelial carcinoma
- •Transitional cell carcinoma
- •Adenocarcinoma (grade = 2) not otherwise specified.
- •4. Documented resistance to platinum/taxane-based chemotherapy, as indicated by
- •relapse/progression while on or within 6 months of completion of treatment in a first-line or second-line setting; or a best response of stable disease (SD) after 6 cycles of platinum/taxane treatment in the first-line setting. Platinum/taxane-based regimens must have included either cisplatin or carboplatin, and paclitaxel.
- •5. Have measurable disease, defined by the presence of at least one radiographicallyconfirmed (computed tomography[CT]/magnetic resonance imaging [MRI]) measurable lesion that can be accurately measured in at least one dimension (longest diameter [LD] to be recorded) as = 20 mm with conventional techniques (CT/MRI), or = 10 mm with spiral CT scan.
- •6. Documentation of progressive disease (PD) according to RECIST or WHO criteria following the immediate prior treatment regimen or a best response of SD after 6 cycles of platinum/taxane treatment in the first-line setting.
- •7. More than 3 weeks (21 days) must have elapsed since completion of the last treatment with any investigational or approved hormonal therapy, radiation, chemotherapy, or surgery, prior to randomization.
- •8. Have an ECOG PS = 2 within 14 days before randomization.
- •9. Have baseline laboratory parameters within the following ranges (without need for
- •hematopoietic growth factor use or transfusion support) within 14 days before randomization:
- •Absolute neutrophil count (ANC) = 1.5 × 109/L
- •Hemoglobin = 9 g/dL
- •Platelet count = 100 × 109/L
- •Total bilirubin = 1.5 times the upper limit of normal (ULN)
- •Aspartate aminotransferase (AST/SGOT) = 2 × ULN
- •Alanine aminotransferase (ALT/SGPT) = 2 × ULN
- •Alkaline phosphatase = 2.5 × ULN.
- •10. Have a calculated creatinine clearance normalized to BSA that is > 40 mL/min determined within 14 days before randomization.
- •11. Disease-free period of > 5 years from any previous malignancies, excluding curativelytreated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- •12. Provide informed consent within 21 days before randomization (informed consent to be obtained prior to any screening procedures).
- •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
- •1. Patients with the following tumor histological epithelial cell types will not be accepted:
- •Malignant Brenner or borderline tumor
- •Low-potential (grade 0) tumor
- •Squamous cell carcinoma
- •Granulosa theca cell tumor
- •Germ cell tumor
- •Sex cord-stromal tumor
- •Carcinosarcoma
- •Mixed Müllerian tumor
- •Metastatic carcinoma from other sites to ovary
- •Low-grade (grade 1) adenocarcinoma.
- •2. Have current evidence of congestive heart failure (New York Heart Association Classification Class II or greater).
- •3. Have a recent onset (< 6 months prior to randomization) of angina pectoris, unstable angina pectoris, uncontrolled ventricular tachycardia, myocardial infarction, stroke, or transient ischemic attacks.
- •4. Have recent history (within 6 months) of uncontrolled seizures.
- •5. Have an active infection (including viral, fungal, bacterial, rickettsial, mycobacterial, or parasitic).
- •6. Have uncontrolled high blood pressure, uncontrolled diabetes mellitus, or other serious underlying medical condition not compatible with study entry.
- •7. Received prior treatment with a camptothecin (topotecan, CPT-11, or investigational camptothecins).
- •8. Received prior treatment with any platinum agent other than cisplatin or carboplatin.
- •9. Received prior radiation therapy to greater than one-third of the hematopoietic sites (one-third of the pelvis and axial skeleton combined).
- •10. Concurrently receiving investigational drug therapy for cancer treatment or investigational treatment for any other indication.
- •11. Have a positive pregnancy test or are unwilling to practice an effective contraceptive method during study (premenopausal patients).
- •12. Are breast feeding.
- •13. Have a life expectancy < 3 months.
- •14. Are judged by the Investigator to be unlikely to be able to fully comply with the study protocol and/or to complete the study or required study procedures.
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