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Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer Clinical research trials and Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer. Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer  Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer
Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer
For Condition: stage 4 colon cancer,recurrent rectal cancer,recurrent colon cancer,Stage 4 rectal cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: OBJECTIVES: - Determine the response in patients with stage IV colorectal cancer expressing c-Kit, Arg, Abl, or PDGF-R treated with imatinib mesylate. - Determine the side effects of this drug in these patients. - Determine the biologic effects of this drug on c-Kit and PDGF-R expression and downstream signaling in these patients. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage IV colorectal cancer - Arg, KIT (CD117), or PDGF-R expression (1+ in 20% of cells) in the tumor or microvasculature - At least one unidimensionally measurable lesion - At least 10 mm by spiral CT scan - No known brain metastases PATIENT CHARACTERISTICS: Age: - Any age Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - At least 12 weeks Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 2.0 mg/dL - AST/ALT less than 2.5 times upper limit of normal Renal: - Creatinine no greater than 2.0 mg/mL Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 3 months after study participation - No other malignancy within the past 3 years except non-melanoma skin cancer or carcinoma in situ of the cervix - No concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: - Not specified Radiotherapy: - More than 4 weeks since prior radiotherapy and recovered Surgery: - More than 3 weeks since prior surgery (excluding diagnostic biopsy) Other: - No more than 2 prior treatments for metastatic disease - No other concurrent investigational agents - No concurrent therapeutic doses of anticoagulants (e.g., warfarin) - No concurrent grapefruit - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RazelleKurzrock, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting James Abbruzzese 713-792-2828
Additional Information:
Study ID Numbers: CDR0000069475; NCI-5652,MDA-ID-01557
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041340
Other Stage 4 Colon Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
2. Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
3. ZD 1839 Plus Combination Chemotherapy in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Colorectal Cancer
4. Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer
5. Tocladesine in Treating Patients With Recurrent or Progressive Metastatic Colorectal Cancer
Related Studies:
Other stage 4 colon cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer
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