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Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic 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 Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer Clinical research trials and Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic 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 Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer. Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic 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 Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer clinical trial. Participants frequently get the best healthcare available for their Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic 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 > "I" Clinical Trials Conditions > Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer  Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
For Condition: adenocarcinoma of the rectum,stage 4 colon cancer,adenocarcinoma of the colon,Stage 4 rectal cancer
Status: Not yet recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, work in 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 II trial to study the effectiveness of combination chemotherapy as first-line therapy in treating patients who have metastaticcolorectal cancer.
Details: OBJECTIVES: Primary - Determine the tumor response rate in patients with metastatic colorectal cancer treated with irinotecan, fluorouracil, leucovorin calcium, and oxaliplatin as first-line treatment. Secondary - Determine the time to tumor progression, time to treatment failure, and overall survival of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. - Determine the quality of life of patients treated with this regimen. - Determine whether UGT1A1 polymorphism is related to toxicity (especially leukopenia, diarrhea, or neutropenia) or response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before each chemotherapy course, and at the end of treatment. Patients are followed every 3 months until 5 years after registration. PROJECTED ACCRUAL: A total of 50-105 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of colorectal adenocarcinoma - Metastatic disease - Not curable by surgery or amenable to radiotherapy with curative intent - Measurable disease - Patients with only lesions measuring 1 cm but < 2 cm must use spiral CT scan for pre- and post-treatment tumor assessments - No known CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - AST 5 times upper limit of normal (ULN) - Bilirubin 0.5 mg/dL above ULN Renal - Creatinine 1.5 times ULN OR - Creatinine clearance 60 mL/min Cardiovascular - No unstable angina - No symptomatic congestive heart failure - No serious uncontrolled cardiac arrhythmia Pulmonary - No prior clinical diagnosis of interstitial lung disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active or uncontrolled infection - No other concurrent serious illness - No pre-existing paraesthesias/dysesthesias of grade 2 that would interfere with function - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent sargramostim (GM-CSF) Chemotherapy - At least 6 months since prior adjuvant chemotherapy - No prior fluorouracil for advanced colorectal cancer - No prior adjuvant oxaliplatin - No prior adjuvant irinotecan Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to > 25% of bone marrow Surgery - At least 4 weeks since prior major surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesErlichman, Study Chair, Mayo Clinic Cancer Center
Additional Information:
Study ID Numbers: CDR0000357571; NCCTG-N0341
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080951
Other Stage 4 Rectal Cancer Studies:
1. Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
2. Fluorouracil, Leucovorin, and Irinotecan in Treating Patients With Recurrent or Refractory Metastatic Unresectable Colorectal Cancer
3. Combination Chemotherapy With or Without Chemoembolization in Treating Patients With Colorectal Cancer Metastatic to the Liver
4. R115777 in Treating Patients With Advanced Colorectal Cancer
5. 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
Related Studies:
Other Stage 4 rectal cancer Clinical Trials
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Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
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