EUCTR2011-002424-41-IT
Active, Not Recruiting
N/A
A Randomized, Double-blind Phase 2 Study Comparing Gemcitabine and Cisplatin in Combination with OGX-427 or Placebo in Patients With Advanced Transitional Cell Carcinoma
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ONCOGENEX TECHNOLOGIES INC
- Enrollment
- 180
- Status
- Active, Not Recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically documented metastatic or locally inoperable, advanced (T4b, N2, N3 or M1\) TCC of the urinary tract (bladder, urethra, ureter and renal pelvis)
- •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.
- •Measurable disease according to RECIST 1\.1\.
- •No prior systemic chemotherapy with the following exceptions:
- •o Prior history of radiosensitizing single agent therapy is allowed.
- •o 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.
- •Karnofsky performance status \=70%.
- •Required laboratory values at baseline:
- •o ANC \= 1\.5 x 109 cells/L and platelet count \= 125 x 109/L.
- •o calculated creatinine clearance \=60 mL/minute according to the modified Cockcroft\-Gault formula.
Exclusion Criteria
- •A candidate for potential curative surgery or radiotherapy.
- •Intravesicular therapy within the past 3 months.
- •Documented brain metastasis or carcinomatous meningitis, treated or untreated.
- •Peripheral neuropathy \=Grade 2\.
- •Cerebrovascular accident, myocardial infarction, or pulmonary embolus within 6 months of randomization.
- •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.
Outcomes
Primary Outcomes
Not specified
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