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

Primary Purpose

Bladder Cancer

Status

Terminated

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

cisplatin

doxorubicin hydrochloride

methotrexate

vinblastine

gene expression profiling

neoadjuvant therapy

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring recurrent bladder cancer, stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Nagoya University Hospital
Shiga Medical Center for Adults
Kyoto University Hospital
National Hospital Organization - Kyoto Medical Center
Osaka Red Cross Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety

Overall survival rate

Size reduction of metastatic lesion

Full Information

NCT ID

NCT00516750

First Posted

August 14, 2007

Last Updated

July 9, 2013

Sponsor

Kyoto University

1. Study Identification

Unique Protocol Identification Number

NCT00516750

Brief Title

Gene Expression Profiling 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 Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Terminated

Why Stopped

Withdrawn due to lack of enrollment.

Study Start Date

July 2007 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Kyoto University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

recurrent bladder cancer, stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

doxorubicin hydrochloride

Intervention Type

Drug

Intervention Name(s)

methotrexate

Intervention Type

Drug

Intervention Name(s)

vinblastine

Intervention Type

Genetic

Intervention Name(s)

gene expression profiling

Intervention Type

Procedure

Intervention Name(s)

neoadjuvant therapy

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Safety

Title

Overall survival rate

Title

Size reduction of metastatic lesion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Osamu Ogawa, MD, PhD

Organizational Affiliation

Kyoto University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Nagoya University Hospital

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

Shiga Medical Center for Adults

City

Moriyama

State/Province

Shiga

ZIP/Postal Code

524-8524

Country

Japan

Facility Name

Kyoto University Hospital

City

Kyoto

ZIP/Postal Code

606-8507

Country

Japan

Facility Name

National Hospital Organization - Kyoto Medical Center

City

Kyoto

ZIP/Postal Code

612-0861

Country

Japan

Facility Name

Osaka Red Cross Hospital

City

Osaka

ZIP/Postal Code

543-8555

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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