ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) in the Intravescical Therapy of Patients With Non-muscle Invasive Cancer of the Bladder. A Phase II Marker Lesion. STUDY
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 14
- 主要终点
- CR at control visit (V8) after intravescical administration of Oncofid-P-B on a papillary marker tumor.
研究概览
简要总结
The purpose of the study is to assess, at control visit (V8), the ablative activity of intravesical administration of Oncofid-P-B on a papillary marker tumor on patients suffering from multiple primary and recurrent Ta G1-G2 papillary cancer of the bladder after 6 weeks of weekly study drug administration, through number and percentage of patients with Complete Response.
详细描述
This study will investigate the preliminary activity of Oncofid-P-B administered by intravescical route at the Recommended Dose of 600 mg, once a week, for six weeks evaluating the ablative activity on a papillary marker tumor in patients suffering from non-muscle invasive cancer of the bladder. When a patient will present a Complete Response at the end of the six weekly administration of Oncofid-P-B , he/she can enter a second phase of the study defined maintenance phase. During this phase, the patients will be treated with the study drug administered by intravesical infusion once a month for 2 cycles of treatment with the duration of 6 months separated by a period during which study drug will not be administered, due to the necessity to perform histological evaluation of efficacy. This scheme will follow a clinical usual approach for the maintenance treatment of patients suffering from non-muscle invasive cancer of the bladder.
Complete Response is defined as follows: complete disappearance of the marker lesion, as confirmed by negative post-treatment cystoscopy including a biopsy at the marker lesion site and the absence of new tumors at other site and negative cytology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes aged > 18 years, women in menopause (defined as surgically sterile or one year postmenopausal);
- •Cytological or histological diagnosis of bladder cancer;
- •Multiple primary or recurrent Ta G1-G2 papillary cancer;
- •ECOG Performance Status 0 to 1;
- •Adequate bone marrow function: neutrophils ≥1.5 103/mL; platelet count ≥100 103/ mm3; Hb ≥ 10 g/dL;
- •Written informed consent;
- •Willing and able to comply with the protocol for the duration of the study.
排除标准
- •Hypersensitivity to Paclitaxel or one of its constituents;
- •T1 papillary cancer or muscle-invasive disease (T2-T4) ;
- •Previous or concomitant tumor of the upper urinary tract, of the prostatic urethra, CIS;
- •Any other malignancy diagnosed within 3 years of study entry (except basal or squamous cell skin cancers or non-invasive cancer of the cervix);
- •Presence of significant urologic disease interfering with intravesical therapy;
- •Participation in another clinical trial with any investigational drug within 30 days prior to study screening or concurrent treatment with other experimental drugs;
- •Other chemotherapy or radiotherapy within four weeks of study entry;
- •Previous intravesical immunotherapy or chemotherapy less than 3 months before study entry;
- •Bladder capacity less than 300 mL;
- •Renal and hepatic function values exceeding 2 times the upper normal value;
- •Severe cardiovascular diseases considered a contraindication to intravesical treatment;
- •Pregnant, lactating or childbearing potential aged women.
研究组 & 干预措施
Oncofid-P-B
Oncofid-P-B will be administered once a week for 6 weeks in the first treatment phase and once a month for 6 months followed by other 6 months in the second maintenance phase
干预措施: Oncofid-P-B (Drug)
结局指标
主要结局
CR at control visit (V8) after intravescical administration of Oncofid-P-B on a papillary marker tumor.
时间窗: Visit 8 will be performed 2-4 weeks after the last treatment visit (Visit 7)
Rate of complete response, estimated at V8, after 6 weeks of weekly study drug administration: number and percentage of patients with complete response. Complete response is defined as follows: complete disappearance of the marker lesion, as confirmed by negative post-treatment cystoscopy including a biopsy at the marker lesion site and the absence of new tumors at other sites and negative cytology.
次要结局
- Time to relapse after Oncofid-P-B instillation during the maintenance phase.(The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks).)
- Number of patients with relapse within V 22.(The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks).)
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0"(The second treatment maintenance phase constituted by 2 treatment periods with a duration of 6 months each (comprehensively considered equal to 52 weeks).)