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

NCT ID: NCT00516750

Last Updated: 2013-07-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-02-28

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.

Conditions

Bladder Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cisplatin

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

methotrexate

Intervention Type: DRUG

vinblastine

Intervention Type: DRUG

gene expression profiling

Intervention Type: GENETIC

neoadjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyoto University

OTHER

Sponsor Role: lead

Principal Investigators

Osamu Ogawa, MD, PhD

Role: STUDY_CHAIR

Kyoto University Hospital

Locations

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

National Hospital Organization - Kyoto Medical Center

Kyoto, Kyoto, Japan

Shiga Medical Center for Adults

Moriyama, Shiga, Japan

Osaka Red Cross Hospital

Osaka, , Japan

Countries

Japan

Other Identifiers

CDR0000561303

Identifier Type: REGISTRY

Identifier Source: secondary_id

TRIC-UHA-GU-03-01

Identifier Type: -

Identifier Source: org_study_id