Bladder Cancer Clinical Trial
Official title:
Phase II Clinical Trial Concerning Gene Expression Profiling to Predict the Chemosensitivity of Invasive Bladder Cancer
RATIONALE: Drugs used in chemotherapy, such as methotrexate, vinblastine, doxorubicin, and
cisplatin, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Giving more than one drug (combination
chemotherapy) may kill more tumor cells. Evaluating blood or tissue samples from patients
with cancer may help doctors learn more about changes that occur in DNA, identify biomarkers
related to cancer, and predict how well patients will respond to combination chemotherapy.
PURPOSE: This phase II trial is studying gene expression profiling to see how well it works
in predicting response to treatment in patients with invasive bladder cancer receiving
methotrexate, vinblastine, doxorubicin, and cisplatin.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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