Phase II Clinical Trial Concerning Gene Expression Profiling to Predict the Chemosensitivity of Invasive Bladder Cancer
- 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.
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
Detection of genes associated with sensitivity to the chemotherapy in tumor size reduction of original bladder tumor
Osamu Ogawa, MD, PhD
United States: Federal Government