|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 8, 2002 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | May 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Response by RECIST criteria at 8 weeks [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Response by RECIST criteria at 8 weeks | ||||
| Change History | Complete list of historical versions of study NCT00041340 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Biologic effects by patient reports and observations at 8 weeks or completion of study treatment [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Biologic effects by patient reports and observations at 8 weeks or completion of study treatment | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer | ||||
| Official Title ICMJE | Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known As(STI571) (NSC #716051) In Patients With Colorectal Cancer Stage IV | ||||
| Brief Summary | RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells by blocking certain enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have stage IV colorectal cancer. |
||||
| Detailed Description | OBJECTIVES:
OUTLINE: Patients receive oral imatinib mesylate twice daily. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better continue therapy until disease progression or 1 year after complete response. PROJECTED ACCRUAL: A total of 14-37 patients will be accrued for this study within 5-37 months. |
||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Colorectal Cancer | ||||
| Intervention ICMJE | Drug: imatinib mesylate | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* 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 ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 37 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| 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:
|
||||
| Gender | Both | ||||
| Ages | |||||
| 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 ID ICMJE | NCT00041340 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000069475, MDA-ID-01557, NCI-5652 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2006 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||