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FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen Clinical research trials and FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen. FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen clinical trial. Human subjects often obtain the finest healthcare possible for their FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen  FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen
FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen
For Condition: stage 4 colon cancer,Stage 4 rectal cancer,recurrent rectal cancer,recurrent colon cancer
Status: Not yet recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as FR901228 work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have advanced colorectal cancer that has progressed after one previous fluorouracilregimen.
Details: OBJECTIVES: Primary - Determine the response rate (complete and partial response) in patients with advanced colorectal cancer that has progressed after a prior fluorouracil-containing regimen when treated with FR901228. Secondary - Determine the toxicity of this drug in these patients. - Determine the median and overall survival of patients treated with this drug. - Determine the time to tumor progression in patients treated with this drug. - Correlate changes in the p21 gene and thymidylate synthase expression with response and time to progression in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive FR901228 IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 14-42 patients will be accrued for this study within 10-14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed colorectal cancer - Advanced disease - At least 1 unidimensionally measurable lesion - At least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan - Failed 1, and only 1, prior fluorouracil-containing regimen (e.g., fluorouracil/leucovorin calcium, fluorouracil/leucovorin calcium/irinotecan, or fluorouracil/leucovorin calcium/oxaliplatin) - Not amenable to curative surgery - Must have pre-treatment tumor specimens available OR willing to undergo pre-treatment tumor biopsy - Tumor must be accessible for core needle biopsy - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 OR - Karnofsky 70-100% Life expectancy - More than 12 weeks Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 - WBC 3,000/mm^3 Hepatic - AST and ALT 2.5 times upper limit of normal - Bilirubin normal Renal - Creatinine normal OR - Creatinine clearance 60mL/min Cardiovascular - LVEF > 40% by MUGA - QTc < 500 msec - No significant cardiac disease - No New York Heart Association class III or IV congestive heart failure - No myocardial infarction within the past year - No prior serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation 3 beats in a row) - No uncontrolled dysrhythmias - No poorly controlled angina Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reaction to compounds of similar chemical or biological composition to FR901228 - No peripheral neuropathy > grade 1 - No other concurrent uncontrolled illness - No active or ongoing infection - No poorly controlled comorbidities - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - No other concurrent biologic therapy Chemotherapy - See Disease Characteristics - Prior adjuvant chemotherapy allowed - More than 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No more than 1 prior chemotherapy regimen for metastatic colorectal cancer - No prior FR901228 - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy Surgery - Not specified Other - No other concurrent drugs with known histone deacetylase inhibitor activity (e.g., sodium valproate) - No concurrent agents that cause QTc prolongation - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent antineoplastic agents - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HedyKindler, Study Chair, University of Chicago Cancer Research Center
Additional Information:
Study ID Numbers: CDR0000361712; NCI-6349,UCCRC-NCI-6349
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082901
Other Stage 4 Colon Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer
2. Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer
3. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
4. BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
5. Antineoplaston Therapy in Treating Patients With Colon Cancer
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FR901228 in Treating Patients With Advanced Colorectal Cancer That Has Progressed After a Previous Fluorouracil-Containing Regimen
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