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

OncoGenex Technologies Inc.0 sites180 target enrollmentOctober 28, 2011

Overview

No summary available.

Registry

who.int

Start Date

October 28, 2011

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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:

•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).