Gene Expression Profiling in Patients With Invasive Bladder Cancer Receiving Methotrexate, Vinblastine, Doxorubicin, and Cisplatin
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.
Drug: doxorubicin hydrochloride
Genetic: gene expression profiling
Procedure: neoadjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Clinical Trial Concerning Gene Expression Profiling to Predict the Chemosensitivity of Invasive Bladder Cancer|
- Detection of genes associated with sensitivity to the chemotherapy in tumor size reduction of original bladder tumor [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Overall survival rate [ Designated as safety issue: No ]
- Size reduction of metastatic lesion [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516750
|Nagoya University Hospital|
|Nagoya, Aichi, Japan, 466-8560|
|Shiga Medical Center for Adults|
|Moriyama, Shiga, Japan, 524-8524|
|Kyoto University Hospital|
|Kyoto, Japan, 606-8507|
|National Hospital Organization - Kyoto Medical Center|
|Kyoto, Japan, 612-0861|
|Osaka Red Cross Hospital|
|Osaka, Japan, 543-8555|
|Study Chair:||Osamu Ogawa, MD, PhD||Kyoto University|