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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005086 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IV locally advanced or metastatic bladder cancer.
Condition | Intervention | Phase |
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Bladder Cancer |
Drug: cisplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: methotrexate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of "Sequential Doublets" Chemotherapy in Patients With Locally Advanced or Metastatic Bladder Cancer |
Study Start Date: | August 1999 |
OBJECTIVES:
OUTLINE: Patients receive methotrexate IV on days 1 and 8 and docetaxel IV over 1 hour on day 8 every 3 weeks for 9 weeks. Patients then receive cisplatin IV over 2 hours on day 1 and gemcitabine IV over 100 minutes on days 1 and 8 every 3 weeks for 9 weeks. This 18 week sequential regimen constitutes 1 full course. Treatment continues in the absence of unacceptable toxicity or disease progression.
Patients are followed until death or until 2 years after study entry, whichever comes first.
PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 9-24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV locally advanced or metastatic transitional cell carcinoma of the urothelium that is not amenable to curative surgery or radiotherapy
No active CNS metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
Louis A. Weiss Memorial Hospital | |
Chicago, Illinois, United States, 60640 | |
Oncology/Hematology Associates of Central Illinois, P.C. | |
Peoria, Illinois, United States, 61602 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, Indiana | |
Fort Wayne Medical Oncology and Hematology, Inc. | |
Fort Wayne, Indiana, United States, 46885-5099 |
Study Chair: | Walter M. Stadler, MD, FACP | University of Chicago |
Study ID Numbers: | CDR0000067702, UCCRC-11203, NCI-G00-1733 |
Study First Received: | April 6, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005086 History of Changes |
Health Authority: | United States: Federal Government |
stage IV bladder cancer transitional cell carcinoma of the bladder |
Antimetabolites Urinary Tract Neoplasm Cystocele Immunologic Factors Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Neoplasms Folic Acid Antagonists Carcinoma, Transitional Cell Urologic Neoplasms Antiviral Agents Immunosuppressive Agents |
Carcinoma Folic Acid Docetaxel Radiation-Sensitizing Agents Cisplatin Urologic Diseases Methotrexate Bladder Neoplasm Antirheumatic Agents Gemcitabine Transitional Cell Carcinoma |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Reproductive Control Agents Urologic Neoplasms Neoplasms by Site Urologic Diseases Therapeutic Uses Abortifacient Agents Methotrexate |
Gemcitabine Dermatologic Agents Nucleic Acid Synthesis Inhibitors Urinary Bladder Diseases Urinary Bladder Neoplasms Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Antirheumatic Agents |