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Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer health trials occur in a lot of of places throughout 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer. Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer  Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer
Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer
For Condition: Stage 4 rectal cancer,recurrent rectal cancer,recurrent colon cancer,adenocarcinoma of the rectum,stage 4 colon cancer,adenocarcinoma of the colon
Status: No longer recruiting
Sponsor(s): Medical Research Council ,
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. It is not yet known which regimen of combination chemotherapy is more effective for advanced colorectal cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of fluorouracil combined with leucovorin and either irinotecan or oxaliplatin in treating patients who have unresectablemetastatic colorectal cancer.
Details: OBJECTIVES: - Compare the efficacy of combination chemotherapy comprising fluorouracil (5-FU) with leucovorin calcium (CF) and either irinotecan (CPT-11) or oxaliplatin vs standard sequential single-agent therapy comprising 5-FU with CF followed by CPT-11 in patients with unresectable metastatic colorectal cancer. - Determine whether combination chemotherapy is best used as first-line therapy or reserved for second-line therapy after progression on first-line single-agent therapy in these patients. - Compare the efficacy and toxicity of an irinotecan-containing regimen vs an oxaliplatin-containing regimen in these patients. - Compare the overall survival, progression-free survival, and quality of life of patients treated with these regimens. - Compare the safety and toxicity of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of five treatment arms. - Arm I (standard therapy): Patients receive first-line chemotherapy comprising leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours on days 1-2 every 14 days. Patients with progressive disease then receive second-line therapy comprising irinotecan IV over 90 minutes on day 1 every 21 days. - Arm II: Patients receive first-line chemotherapy as in arm I. Patients with progressive disease then receive second-line therapy comprising irinotecan IV over 30 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1-2 every 14 days. - Arm III: Patients receive first-line chemotherapy comprising irinotecan, leucovorin calcium, and fluorouracil as in second-line therapy of arm II. - Arm IV: Patients receive first-line chemotherapy as in arm I. Patients with progressive disease then receive second-line therapy comprising leucovorin calcium IV and oxaliplatin IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours on days 1-2 every 14 days. - Arm V: Patients receive first-line chemotherapy comprising leucovorin calcium, oxaliplatin, and fluorouracil as in second-line therapy of arm IV. Treatment continues in all arms in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at weeks 6 and 12, and then every 12 weeks thereafter. PROJECTED ACCRUAL: A total of 2,100 patients (700 in arm I and 350 each in arms II-V) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic adenocarcinoma of the colon or rectum - Unresectable disease - Measurable or evaluable disease - No partial or complete bowel obstruction PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - WBC greater than 4,000/mm^3 - Platelet count greater than 150,000/mm^3 Hepatic: - Bilirubin less than 1.25 times upper limit of normal (ULN) - Alkaline phosphatase less than 5 times ULN - AST or ALT less than 3 times ULN - No Gilbert's syndrome or other congenital abnormality of biliary transport (e.g., Crigler-Najjar syndrome or Dubin-Johnson syndrome) Renal: - Creatinine clearance greater than 50 mL/min OR - Glomerular filtration rate normal Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - No other uncontrolled medical illness - No other prior or concurrent malignancy that would preclude study entry - No chronic diarrhea or inflammatory bowel disease - No grade 2 or greater pre-existing neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 6 months since prior adjuvant chemotherapy - Prior adjuvant fluorouracil allowed - No prior chemotherapy for metastatic disease - No prior oxaliplatin or irinotecan Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - No prior transplantation surgery requiring immunosuppressive therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
M.T.Seymour, Study Chair, Medical Research Council
Medical Research Council Clinical Trials Unit
London, England, NW1 2DA
United Kingdom
Additional Information:
Study ID Numbers: CDR0000068372; MRC-CR08-FOCUS,EU-20038,ISRCTN79877428
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008060
Other Recurrent Colon Cancer Studies:
1. Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer
2. Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
3. SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer
4. Gemcitabine in Treating Patients With Advanced Colorectal Cancer
5. Intravenous Compared With Intrahepatic Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
Related Studies:
Other recurrent colon cancer Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer
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