EUCTR2011-002424-41-ES进行中（未招募）不适用
A Randomized, Double-blind Phase 2 Study Comparing Gemcitabine and Cisplatin in Combination with OGX-427 or Placebo in Patients With Advanced Transitional Cell CarcinomaEstudio fase 2, doble ciego y aleatorizado para comparar lagemcitabina y el cisplatino en combinación con OGX-427 oplacebo en pacientes con carcinoma de células transicionalesavanzado
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- All
入选标准
- •1) Age = 18 years at the time of consent.
- •2) Histologically documented metastatic or locally inoperable advanced TCC of the urinary tract (bladder, urethra, ureter and renal pelvis) (T4b, N2, N3 or M1 disease).
- •NOTE: Certain mixed histologies that are predominately (= 50%) TCC are eligible: squamous, adenocarcinoma, and undifferentiated. Mixed undifferentiated histology requires IHC consistent with a TCC origin. Mixed small-cell histologies are excluded.
- •3) Measurable disease defined as at least one target lesion that has not been irradiated and can be accurately measured in at least one dimension by RECIST 1.1 criteria.
- •4) No prior systemic chemotherapy with the following exceptions:
- •- Prior use of radiosensitizing single agent therapy is allowed.
- •- Prior neoadjuvant and adjuvant systemic chemotherapy are permissible if the interval from the end of therapy to the diagnosis of metastatic disease is at least 12 months.
- •5) Minimum of 21 days have elapsed since prior major surgery or radiation therapy, with recovery from any adverse events.
- •6) Karnofsky performance status =70%.
- •7) Required laboratory values at baseline:
- •- ANC = 1.5x10^9 cells/L
- •- platelet count = 125 x 10^9/L
- •- Calculated creatinine clearance =60 mL/minute (by modified Cockcroft-Gault formula).
- •- bilirubin = 1.5 x ULN (= 2.5 x ULN if secondary to Gilbert's disease)
- •- AST and ALT = 3.0 x ULN
- •8) If of child-bearing potential, willing to use contraceptive measures during and for 3 months after completion of therapy.
- •9) willing to give written informed consent
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1) A candidate for potential curative surgery or radiotherapy.
- •2) Intravesical therapy within the last 3 months,
- •3) Documented brain metastasis or carcinomatous meningitis, treated or untreated. NOTE: Brain imaging is not required unless the patient has symptoms or physical signs of CNS disease.
- •4) Peripheral neuropathy =Grade 2.
- •5) Known serious hypersensitivity to gemcitabine, cisplatin or carboplatin.
- •6) Current serious, uncontrolled medical condition such as congestive heart failure, angina, hypertension, arrhythmia, diabetes mellitus, infection, etc. or any condition such as a psychiatric illness which in the opinion of the investigator would make the patient unacceptable for the protocol.
- •7) Cerebrovascular accident, myocardial infarction or pulmonary embolus within 6 months of randomization.
- •8) History of significant bleeding disorder or recent bleeding event within 3 months of randomization or currently receiving warfarin anticoagulation therapy
- •9) Active second malignancy (except non-melanomatous skin cancer): active secondary malignancy is defined as a current need for cancer therapy or a high possibility (>30%) of recurrence during the study.
- •10) Pregnant or nursing (must have a negative serum or urine pregnancy test within 72 hours prior to randomization).
- •11) Participating in a concurrent clinical trial of an experimental drug, vaccine or device. Participation in an observational study is allowed.
研究者
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