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

Phase 2

Terminated

• Conditions: Bladder Cancer

• Registration Number: NCT00516750
• Lead Sponsor: Kyoto University

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-14
• Study First Submitted QC: 2007-08-14
• Study First Posted: 2007-08-15
• Status Verified: 2008-03
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety
Overall survival rate
Size reduction of metastatic lesion

Trial Locations

Locations (5)

Shiga Medical Center for Adults; 🇯🇵 Moriyama, Shiga, Japan

Nagoya University Hospital; 🇯🇵 Nagoya, Aichi, Japan

Kyoto University Hospital; 🇯🇵 Kyoto, Japan

National Hospital Organization - Kyoto Medical Center; 🇯🇵 Kyoto, Japan

Osaka Red Cross Hospital; 🇯🇵 Osaka, Japan