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Bladder Cancer

OGX-427 Plus Chemotherapy for Advanced Bladder Cancer (UW11028)
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
Status Conditions Phase Study ID
Closed Urologic Neoplasms
Metastatic Bladder Cancer
Urinary Tract Neoplasms
Phase II UW 11028
NCT01454089
Summary

This study evaluates the safety and efficacy of standard chemotherapy in combination with the investigational drug OGX-427 in patients with advanced bladder cancer.


Investigator
Evan Ya-Wen Yu, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  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 chemotherapy may be allowed
  5. Minimum of 21 days since prior major surgery or radiation therapy
  6. Karnofsky performance status ≥70%
  7. Required laboratory values at baseline:

    • ANC ≥ 1.5x109 cells/L
    • platelet count ≥ 125 x 109/L
    • Calculated creatinine clearance ≥60 mL/minute
    • 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 contraceptives
  9. Willing to give written informed consent
Exclusions (conditions that would prevent participation in this study)
  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. 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
  9. Pregnant or nursing (must have a negative serum or urine pregnancy test within 72 hours prior to randomization)
  10. Participating in a concurrent clinical trial of an experimental drug, vaccine or device. Participation in an observational study is allowed.
Last Updated
April 11, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.