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Bladder Cancer

Sirolimus + Cisplatin/Gemcitabine for Bladder Cancer (8027)
A Phase 1-2 Study of Rapamycin (Sirolimus) and Cisplatin/Gemcitabine for Treatment of Patients With Bladder Cancer
Status Conditions Phase Study ID
Recruiting Bladder Cancer Phase I/II 8027
NCT01938573
Summary

This phase I/II trial studies the side effects and the best dose of sirolimus when given together with cisplatin and gemcitabine hydrochloride and to see how well it works in treating patients with bladder cancer. Biological therapies, such as sirolimus, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sirolimus together with cisplatin and gemcitabine hydrochloride may be an effective treatment for bladder cancer.

 


Investigator
Bruce Montgomery, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information
  • Histologically or cytologically confirmed carcinoma of the bladder of all histologies except neuroendocrine differentiation or squamous cell histology
  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 1
  • Eligibility for Phase 1 and Phase 2 components:

    • Phase 1 - clinical T3 or T4 or N1 or M1 cancer which is untreated or previously treated with cisplatin based therapy with primary tumor still present in the bladder and amenable to sampling before and after treatment, as indicated
    • Phase 2 - clinical T2-4 N0 or N1 untreated with primary tumor still present in the bladder and amenable to sampling before and after treatment, as indicated
  • Life expectancy >= 12 weeks
  • No prior malignancy is allowed except:

    • Adequately treated basal cell or squamous cell skin cancer or
    • In situ carcinoma of any site or
    • Other adequately treated malignancy for which the patient is currently disease free for at least one year
  • Absolute neutrophil count >= 1.5 x 10^9 cells/L
  • Hemoglobin (Hgb) >= 9.0 g/dL
  • Platelets >= 100,000 x 10^9/L
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin levels =< 1.5 x upper limit of normal (ULN)
  • Total bilirubin =< 1.5 x ULN
  • Serum creatinine < 1.5 mg/DL OR creatinine clearance >= 50 mL/min
Exclusions (conditions that would prevent participation in this study)
  • Patients currently receiving active therapy for other neoplastic disorders
  • Known parenchymal brain metastasis
  • Active or symptomatic viral hepatitis or chronic liver disease
  • Estimated creatinine clearance less than 50 ml/minute
  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class II-IV heart disease or cardiac ejection fraction measurement of < 45 % at baseline, if done
  • Atrial fibrillation, or other cardiac arrhythmia requiring medical therapy
  • Administration of an investigational therapeutic within 30 days of cycle 1, day 1
  • Patients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consent
  • Patients with medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligible
  • Any condition which, in the opinion of the investigator, would preclude participation in this trial
Last Updated
January 23, 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.