Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Biomarker/Laboratory analysis, Treatment Active 20 to 80 Other TRIC-UHA-GU-03-01 UHA GU 03-01, NCT00516750

Objectives

Primary

1. Analyze the correlation between gene expression profile and the effect of chemotherapy and detect the significant cluster of genes useful to predict chemosensitivity.
2. Confirm the reduction in original tumor size in patients with invasive bladder cancer treated with methotrexate, vinblastine, doxorubicin hydrochloride, and cisplatin.

Secondary

1. Determine the safety of this regimen in these patients.
2. Determine the overall survival rate in patients treated with this regimen.
3. Assess the reduction in size of metastatic lesions in patients treated with this regimen.

Entry 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

Prior/Concurrent Therapy:

• No prior systemic chemotherapy

Patient Characteristics:

• ECOG performance status 0-1
• WBC ≥ 3,000/mm³
• Neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

Outcomes

Detection of genes associated with sensitivity to the chemotherapy in tumor size reduction of original bladder tumor

Safety
Overall survival rate
Size reduction of metastatic lesion

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.

Trial Contact Information

Trial Lead Organizations

Kyoto University Hospital

Osamu Ogawa, MD, PhD, Protocol chair		Ph: 81-75-751-3329

Japan
	Osaka
	Osaka Red Cross Hospital
		Kazuo Nishimura, MD	Ph:  81-6-6774-5111-5192
Aichi
	Nagoya
	Nagoya University Hospital
		Yasushi Yoshino, MD	Ph:  81-52-744-2985
Kyoto
	Kyoto
	Kyoto University Hospital
		Osamu Ogawa, MD, PhD	Ph:  81-75-751-3329
	National Hospital Organization - Kyoto Medical Center
		Hiroshi Okuno, MD	Ph:  81-75-641-9161
Shiga
	Moriyama
	Shiga Medical Center for Adults
		Yuzuru Megumi, MD	Ph:  81-77-582-5031

Registry Information
Official Title		Phase II Clinical Trial Concerning Gene Expression Profiling to Predict the Chemosensitivity of Invasive Bladder Cancer
Trial Start Date		2007-07-31
Trial Completion Date		2011-03-31 (estimated)
Registered in ClinicalTrials.gov		NCT00516750
Date Submitted to PDQ		2007-07-31
Information Last Verified		2008-03-30

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