Phase II Clinical Trial Concerning Gene Expression Profiling to Predict the Chemosensitivity of Invasive Bladder Cancer
20 Years
80 Years
Both
Bladder Cancer
Trial Information
Phase II Clinical Trial Concerning Gene Expression Profiling to Predict the Chemosensitivity of Invasive Bladder Cancer
OBJECTIVES:
Primary
- Analyze the correlation between gene expression profile and the effect of chemotherapy
and detect the significant cluster of genes useful to predict chemosensitivity.
- Confirm the reduction in original tumor size in patients with invasive bladder cancer
treated with methotrexate, vinblastine, doxorubicin hydrochloride, and cisplatin.
Secondary
- Determine the safety of this regimen in these patients.
- Determine the overall survival rate in patients treated with this regimen.
- Assess the reduction in size of metastatic lesions in patients treated with this
regimen.
OUTLINE: This is a multicenter study.
Patients receive methotrexate on days 1, 15, and 22, vinblastine on days 2, 15, and 22,
doxorubicin hydrochloride and cisplatin on day 2. Treatment repeats every 4 weeks in the
absence of disease progression or unacceptable toxicity.
Patient samples will be collected for gene expression profiling.
After completion of study treatment, patients are followed for 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of invasive bladder cancer
- Must be confirmed by chest and abdominal CT scan OR pelvic MRI scan and transurethral
biopsy (with definitive muscle invasion > T2) within 4 weeks prior to registration
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC ≥ 3,000/mm^3
- Neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Total bilirubin ≤ 1.5 mg/dL
- Serum creatinine ≤ 1.5 mg/dL
- AST and ALT ≤ 2.5 x upper limit of normal
- Not pregnant
- No liver cirrhosis
- No ischemic cardiovascular disease or arrhythmia for which treatment is necessary
- No cardiac infarction within the past 6 months
- No interstitial pneumonia, pulmonary fibrosis, or any other diseases by which oxygen
inhalation therapy is needed
- No active cancerous lesion other than upper urinary tract tumor
- No high fever or any other infectious symptom
- No uncontrolled hypertension or diabetes mellitus
PRIOR CONCURRENT THERAPY:
- No prior systemic chemotherapy
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Detection of genes associated with sensitivity to the chemotherapy in tumor size reduction of original bladder tumor
Safety Issue:
No
Principal Investigator
Osamu Ogawa, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Kyoto University
Authority:
United States: Federal Government
Study ID:
CDR0000561303
NCT ID:
NCT00516750
Start Date:
July 2007
Completion Date:
Related Keywords:
- Bladder Cancer
- recurrent bladder cancer
- stage II bladder cancer
- stage III bladder cancer
- stage IV bladder cancer
- Urinary Bladder Neoplasms
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