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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000561303 | Registry Identifier | PDQ (Physician Data Query) |
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Withdrawn due to lack of enrollment.
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| doxorubicin hydrochloride | Drug | |||
| methotrexate | Drug | |||
| vinblastine | Drug | |||
| gene expression profiling | Genetic | |||
| neoadjuvant therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of genes associated with sensitivity to the chemotherapy in tumor size reduction of original bladder tumor |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | ||
| Overall survival rate | ||
| Size reduction of metastatic lesion |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Osamu Ogawa, MD, PhD | Kyoto University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8560 | Japan | ||
| Kyoto University Hospital |
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| Kyoto |
| Kyoto |
| 606-8507 |
| Japan |
| National Hospital Organization - Kyoto Medical Center | Kyoto | Kyoto | 612-0861 | Japan |
| Shiga Medical Center for Adults | Moriyama | Shiga | 524-8524 | Japan |
| Osaka Red Cross Hospital | Osaka | 543-8555 | Japan |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D004317 | Doxorubicin |
| D008727 | Methotrexate |
| D014747 | Vinblastine |
| D020869 | Gene Expression Profiling |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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