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

Bladder Cancer Clinical Trial

Official title:

Phase II Clinical Trial Concerning Gene Expression Profiling to Predict the Chemosensitivity of Invasive Bladder Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00516750
• Other study ID #: TRIC-UHA-GU-03-01
• Secondary ID: CDR0000561303
• Status: Terminated
• Phase: Phase 2
• First received: August 14, 2007
• Last updated: July 9, 2013
• Start date: July 2007
• Est. completion date: February 2009

Study information

• Verified date: March 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• cisplatin

• doxorubicin hydrochloride

• methotrexate

• vinblastine

Genetic:
• gene expression profiling

Procedure:
• neoadjuvant therapy

Locations

Country	Name	City	State
Japan	Kyoto University Hospital	Kyoto
Japan	National Hospital Organization - Kyoto Medical Center	Kyoto
Japan	Shiga Medical Center for Adults	Moriyama	Shiga
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Osaka Red Cross Hospital	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of genes associated with sensitivity to the chemotherapy in tumor size reduction of original bladder tumor			No
Secondary	Safety			Yes
Secondary	Overall survival rate			No
Secondary	Size reduction of metastatic lesion			No