The trial is designed to determine the efficacy of OGX-427 Vs placebo in combination with Gemcitabine and Cisplatin in patients with Urinary tract cancer.El estudio está diseñado para determinar la eficacia de OGX-427 vS placebo en combinación con Gemcitabina y Cisplatino en pacientes con cancer en tracto urinario

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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