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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00053209 |
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining pemetrexed disodium with gemcitabine in treating patients who have advanced cancer of the urothelium.
Condition | Intervention | Phase |
---|---|---|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: gemcitabine hydrochloride Drug: pemetrexed disodium |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer |
Study Start Date: | April 2004 |
Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive pemetrexed disodium IV over 10 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Patients also receive cyanocobalamin intramuscularly once every 9 weeks and folic acid orally once daily beginning on day -6 and continuing until 3 weeks after the completion of study therapy. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 24-46 patients will be accrued for this study within 15 -18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed cancer of the urothelium (renal pelvis, ureter, bladder, or urethra)
Any of the following types:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Robert Dreicer, MD, FACP | The Cleveland Clinic |
Study ID Numbers: | CDR0000269302, ECOG-E4802 |
Study First Received: | January 27, 2003 |
Last Updated: | May 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00053209 History of Changes |
Health Authority: | United States: Federal Government |
metastatic transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter regional transitional cell cancer of the renal pelvis and ureter transitional cell carcinoma of the bladder recurrent bladder cancer stage III bladder cancer |
stage IV bladder cancer anterior urethral cancer posterior urethral cancer recurrent urethral cancer urethral cancer associated with invasive bladder cancer |
Antimetabolites Anti-Infective Agents Urinary Tract Neoplasm Immunologic Factors Folate Ureteral Diseases Urogenital Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Vitamin B9 Renal Cancer Urologic Diseases Kidney Neoplasms Urethral Cancer Kidney Diseases |
Bladder Neoplasm Gemcitabine Kidney Cancer Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Folinic Acid Folic Acid Antagonists Immunosuppressive Agents Antiviral Agents Recurrence Carcinoma Folic Acid Pemetrexed Radiation-Sensitizing Agents |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Ureteral Diseases Urogenital Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses |
Urethral Diseases Kidney Diseases Gemcitabine Neoplasms by Histologic Type Urinary Bladder Diseases Urinary Bladder Neoplasms Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Carcinoma Pemetrexed Neoplasms Radiation-Sensitizing Agents |