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

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 Genetic: gene expression profiling Procedure: neoadjuvant therapy	Phase 2

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

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Methotrexate Vinblastine sulfate Vinblastine Methotrexate sodium Cisplatin Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

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
Nagoya University Hospital
Nagoya, Aichi, Japan, 466-8560
Shiga Medical Center for Adults
Moriyama, Shiga, Japan, 524-8524
Kyoto University Hospital
Kyoto, Japan, 606-8507
National Hospital Organization - Kyoto Medical Center
Kyoto, Japan, 612-0861
Osaka Red Cross Hospital
Osaka, Japan, 543-8555

Sponsors and Collaborators

Kyoto University

Investigators

Study Chair:

Osamu Ogawa, MD, PhD

Kyoto University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00516750 History of Changes
Other Study ID Numbers:	CDR0000561303, TRIC-UHA-GU-03-01
Study First Received:	August 14, 2007
Last Updated:	February 11, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Cisplatin
Doxorubicin
Methotrexate
Vinblastine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

Physiological Effects of Drugs
Antibiotics, Antineoplastic
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013