Clinical trial NCT00516750: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: recurrent bladder cancer
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Detection of genes associated with sensitivity to the chemotherapy in tumor size reduction of original bladder tumor
Secondary outcomes:
measure: Safety
measure: Overall survival rate
measure: Size reduction of metastatic lesion
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Moriyama
country: Japan
facility: Shiga Medical Center for Adults
state: Shiga
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Kyoto
country: Japan
facility: National Hospital Organization - Kyoto Medical Center
city: Osaka
country: Japan
facility: Osaka Red Cross Hospital
Study officials:
affiliation: Kyoto University Hospital
name: Osamu Ogawa, MD, PhD
role: STUDY_CHAIR
References: