![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | January 27, 2003 | ||||
Last Updated Date | July 23, 2008 | ||||
Start Date † | April 2004 | ||||
Current Primary Outcome Measures † |
Response as measured by RECIST criteria [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00053209 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
|
||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium | ||||
Official Title † | 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. |
||||
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. |
||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † |
|
||||
Intervention † |
|
||||
Study Arms / Comparison Groups | |||||
Publications * | Dreicer R, Li H, Cooney MM, Wilding G, Roth BJ. Phase 2 trial of pemetrexed disodium and gemcitabine in advanced urothelial cancer (E4802) : a trial of the Eastern Cooperative Oncology Group. Cancer. 2008 May 5; [Epub ahead of print] | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | 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
|
||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00053209 | ||||
Responsible Party | |||||
Secondary IDs †† | ECOG-E4802 | ||||
Study Sponsor † | Eastern Cooperative Oncology Group | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
|
||||
Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | October 2005 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |