Gene Expression Profiling in Patients With Invasive Bladder Cancer Receiving Methotrexate, Vinblastine, Doxorubicin, and Cisplatin
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bladder Cancer
Intervention: cisplatin (Drug); doxorubicin hydrochloride (Drug); methotrexate (Drug); vinblastine (Drug); gene expression profiling (Procedure); neoadjuvant therapy (Procedure)
Phase: Phase 2
Sponsored by: Kyoto University
Official(s) and/or principal investigator(s):
Osamu Ogawa, MD, PhD, Study Chair, Affiliation: Kyoto University
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.
Official title: Phase II Clinical Trial Concerning Gene Expression Profiling to Predict the Chemosensitivity of Invasive Bladder Cancer
Study design: Treatment, Open Label
Primary outcome: Detection of genes associated with sensitivity to the chemotherapy in tumor size reduction of
original bladder tumor
Overall survival rate
Size reduction of metastatic lesion
- 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.
Minimum age: 20 Years.
Maximum age: 80 Years.
- 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
- 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
Locations and Contacts
Osaka Red Cross Hospital, Osaka 543-8555, Japan; Recruiting
Kazuo Nishimura, MD, Phone: 81-6-6774-5111-5192
Kyoto University Hospital, Kyoto 606-8507, Japan; Recruiting
Osamu Ogawa, MD, PhD, Phone: 81-75-751-3329
National Hospital Organization - Kyoto Medical Center, Kyoto 612-0861, Japan; Recruiting
Hiroshi Okuno, MD, Phone: 81-75-641-9161
Nagoya University Hospital, Nagoya, Aichi 466-8560, Japan; Recruiting
Yasushi Yoshino, MD, Phone: 81-52-744-2985
Shiga Medical Center for Adults, Moriyama, Shiga 524-8524, Japan; Recruiting
Yuzuru Megumi, MD, Phone: 81-77-582-5031
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 2007
Last updated: July 23, 2008