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Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer Clinical research trials and Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer. Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer clinical trial. Participants frequently get the best healthcare available for their Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer  Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer
Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer
For Condition: stage 3 rectal cancer,recurrent rectal cancer,Stage 4 rectal cancer,stage 4 colon cancer,recurrent colon cancer,stage 3 colon cancer
Status: Completed
Sponsor(s): Memorial Sloan-Kettering Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of raltitrexed and fluorouracil in treating patients who have colorectal cancer that is metastatic, recurrent, or cannot be surgically removed.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of raltitrexed when administered with fluorouracil in patients with advanced colorectal carcinoma. II. Determine the toxicity and safety of this regimen in these patients. III. Assess, in a preliminary manner, the antitumor activity of this regimen in these patients. PROTOCOL OUTLINE: This is a dose-escalation study of raltitrexed. Patients receive raltitrexed IV over 15 minutes followed 24 hours later by fluorouracil IV. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of raltitrexed until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 6-10 patients are treated at the MTD. Patients are followed for 6 weeks. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-20 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven metastatic, locally recurrent, or surgically unresectable colorectal carcinoma - Measurable disease - No CNS metastasis --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No more than 1 prior chemotherapy regimen; Prior fluorouracil-based regimen for advanced colorectal cancer allowed; Prior fluorouracil with radiotherapy not considered therapy for advanced disease; At least 4 weeks since prior chemotherapy (8 weeks for mitomycin or nitrosoureas) and recovered - Endocrine therapy: No concurrent steroids except for antiemesis or as replacement therapy - Radiotherapy: See Chemotherapy; No prior radiotherapy to more than 30% of bone marrow - Surgery: See Disease Characteristics; At least 4 weeks since prior surgery unless fully recovered - Other: No concurrent vitamin supplements containing folic acid; No other concurrent anticancer therapy --Patient Characteristics-- - Age: 18 and over - Performance status: WHO 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 2,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT no greater than 2.5 times normal (5 times normal if known liver metastases) - Renal: Creatinine no greater than 1.5 mg/dL - Other: No severe concurrent infection; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GarySchwartz, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000065019; MSKCC-95021A4,NCI-V96-0987,ZENECA-MSKCC-95021A4
Study Start Date: April 1995
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002828
Other Recurrent Colon Cancer Studies:
1. Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy
2. Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
3. Erlotinib and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
4. Fluorouracil and Leucovorin Plus Either Irinotecan or Oxaliplatin With or Without Cetuximab in Treating Patients With Previously Untreated Metastatic Adenocarcinoma of the Colon or Rectum
5. Leucovorin and Fluorouracil With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
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Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer
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