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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), March 2008

Sponsored by: Kyoto University
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00516750
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Drug: cisplatin
Drug: doxorubicin hydrochloride
Drug: methotrexate
Drug: vinblastine
Procedure: gene expression profiling
Procedure: neoadjuvant therapy
Phase II

Genetics Home Reference related topics:   bladder cancer   

MedlinePlus related topics:   Bladder Cancer    Cancer   

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride    Cisplatin    Methotrexate    Vinblastine    Vinblastine sulfate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Phase II Clinical Trial Concerning Gene Expression Profiling to Predict the Chemosensitivity of Invasive Bladder Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Detection of genes associated with sensitivity to the chemotherapy in tumor size reduction of original bladder tumor [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Overall survival rate [ Designated as safety issue: No ]
  • Size reduction of metastatic lesion [ Designated as safety issue: No ]

Estimated Enrollment:   100
Study Start Date:   July 2007
Estimated Primary Completion Date:   March 2011 (Final data collection date for primary outcome measure)

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.

  Eligibility
Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516750

Locations
Japan
Osaka Red Cross Hospital     Recruiting
      Osaka, Japan, 543-8555
      Contact: Kazuo Nishimura, MD     81-6-6774-5111-5192        
Kyoto University Hospital     Recruiting
      Kyoto, Japan, 606-8507
      Contact: Osamu Ogawa, MD, PhD     81-75-751-3329        
National Hospital Organization - Kyoto Medical Center     Recruiting
      Kyoto, Japan, 612-0861
      Contact: Hiroshi Okuno, MD     81-75-641-9161        
Japan, Aichi
Nagoya University Hospital     Recruiting
      Nagoya, Aichi, Japan, 466-8560
      Contact: Yasushi Yoshino, MD     81-52-744-2985        
Japan, Shiga
Shiga Medical Center for Adults     Recruiting
      Moriyama, Shiga, Japan, 524-8524
      Contact: Yuzuru Megumi, MD     81-77-582-5031        

Sponsors and Collaborators
Kyoto University

Investigators
Study Chair:     Osamu Ogawa, MD, PhD     Kyoto University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000561303, TRIC-UHA-GU-03-01
First Received:   August 14, 2007
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00516750
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent bladder cancer  
stage II bladder cancer  
stage III bladder cancer  
stage IV bladder cancer  

Study placed in the following topic categories:
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Urogenital Neoplasms
Vinblastine
Urologic Neoplasms
Recurrence
Doxorubicin
Folic Acid
Urologic Diseases
Cisplatin
Methotrexate
Urinary tract neoplasm
Bladder neoplasm

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Antibiotics, Antineoplastic
Neoplasms by Site
Therapeutic Uses
Abortifacient Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Tubulin Modulators
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 07, 2008




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