Gene Expression Profiling in Patients With Invasive Bladder Cancer Receiving Methotrexate, Vinblastine, Doxorubicin, and Cisplatin

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyoto University
• Treatments: Cisplatin; Doxorubicin; Liposomal doxorubicin; Methotrexate; Vinblastine

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