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

NCT00516750 | Terminated Phase 2

• 2 other identifiers: TRIC-UHA-GU-03-01CDR0000561303
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

Bladder Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• Safety

• Overall survival rate

• Size reduction of metastatic lesion

Interventions

cisplatin DRUG

doxorubicin hydrochloride DRUG

methotrexate DRUG

vinblastine DRUG

gene expression profiling GENETIC

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Kyoto University: lead

Study Sites (5)

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

National Hospital Organization - Kyoto Medical Center

Kyoto, Kyoto, 612-0861, Japan

Location

Shiga Medical Center for Adults

Moriyama, Shiga, 524-8524, Japan

Location

Osaka Red Cross Hospital

Osaka, 543-8555, Japan

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cisplatin; Doxorubicin; Methotrexate; Vinblastine; Gene Expression Profiling; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Genetic Techniques; Investigative Techniques; Combined Modality Therapy; Therapeutics

Study Officials

• Osamu Ogawa, MD, PhD

  Kyoto University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 14, 2007
• First Posted: August 15, 2007
• Study Start: July 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 10, 2013

Record last verified: 2008-03

Locations

JP (5)