Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium
Tracking Information | |||||
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First Received Date ICMJE | January 27, 2003 | ||||
Last Updated Date | May 29, 2009 | ||||
Start Date ICMJE | April 2004 | ||||
Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Response as measured by RECIST criteria [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Response as measured by RECIST criteria | ||||
Change History | Complete list of historical versions of study NCT00053209 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium | ||||
Official Title ICMJE | Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer | ||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) | |||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | |||||
Completion Date | |||||
Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00053209 | ||||
Other Study ID Numbers ICMJE | CDR0000269302, ECOG-E4802 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Eastern Cooperative Oncology Group | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | October 2005 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |