METASTATIC UROTHELIAL CARCINOMA:

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.

Trial ID: OGX-427-02

Coordination: CUOG

Trial Design: Phase III

Patient Population: Metastatic urothelial carcinoma of the urinary tract (bladder, urethra, ureter and renal pelvis)

Sample size and primary endpoint: Overall survival

CUOG is undertaking a clinical trial with OncoGenex Technologies Inc. This study is comparing OGX-427 in combination with gemcitabine and cisplatin vs. placebo in combination with gemcitabine and cisplatin in patients with metastatic advanced transitional cell carcinoma (TCC) of the urinary tract (bladder, urethra, ureter and renal pelvis). OGX-427 is an inhibitor of Hsp27 that has been shown to increase apoptosis, inhibit tumor growth and sensitize cells to chemotherapy in a variety of malignancies including bladder cancer.

Eligible patients receive six cycles of Study Drug (either OGX-427 or Placebo) and Gem/Cis, with possibility of weekly Study Drug maintenance following the initial six cycles. The study’s primary endpoint is overall survival. Secondary study objectives include safety, tolerability, efficacy, disease response, and other correlative-science endpoints. Patients must meet these key protocol inclusion points:

  • Histologically documented metastatic or locally inoperable, advanced (T4b, N2, N3 or M1) urothelial cancer (bladder, urethra, ureter and renal pelvis primaries allowed).

NOTE: Certain mixed histologies that are predominately (≥ 50%) urothelial are eligible: squamous, adenocarcinoma, and undifferentiated. Mixed undifferentiated histology requires IHC consistent with a TCC origin. Mixed small-cell his- tologies are excluded.

  • No prior systemic chemotherapy with the following exceptions:
  • Prior history 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.

One hundred and eighty patients from seven countries will participate in this study, and 7 Canadian centres are participating. If you know a patient over 18 years of age who may be eligible for this study, we invite you to consider referral to one of the investigators listed below. As well, they are encouraged to review the listing on clinicaltrials.gov under ID NCT01454089.

With your help and support, we may be able to find a new treatment option for advanced TCC. If you would like addi- tional information on this study, please visit the OncoGenex Technologies website at www.OncoGenex.com.

Investigators participating in the OGX-427-02 study are as follows:

  • Bernie Eigl, MD, British Columbia Cancer Agency, Vancouver, BC, Bernie.Eigl@bccancer.bc.ca (Study PI for Canada)
  • Daniel Heng, MD, Tom Baker Cancer Centre, Calgary, AB, daniel.heng@albertahealthservices.ca
  • Scott North, MD, Cross Cancer Institute, Edmonton AB, scottnor@cancerboard.ab.ca
  • Som Mukherjee, MD, Juravinski Cancer Centre, Hamilton, ON, som.mukherjee@jcc.hhsc.ca
  • Normand Blais, MD, CHUM-Hospital Notre Dame, Montreal, QC, Normand.blais.chum@ssss.gouv.qc.ca
  • Srikala Sridhar, MD, Princess Margaret Hospital, Toronto, ON, srikala.sridhar@uhn.on.ca
  • Pawel Zalewski, MD, R.S. McLaughlin Durham Regional Cancer Centre, Oshawa, ON, pzalewski@lakeridgehealth.on.ca