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Home > "L" Clinical Trials Conditions > Leucovorin and Fluorouracil With or Without Oxaliplatin Compared to Capecitabine With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer  Leucovorin and Fluorouracil With or Without Oxaliplatin Compared to Capecitabine With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
Leucovorin and Fluorouracil With or Without Oxaliplatin Compared to Capecitabine With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
For Condition: Rectal Cancer,Colon Cancer,Quality of Life
Status: Recruiting
Sponsor(s): National Cancer Research Institute (NCRI) , Medical Research Council
Synopsis: RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, capecitabine, and oxaliplatin, 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 whether leucovorin and fluorouracil with or without oxaliplatin is more effective than capecitabine with or without oxaliplatin in treating patients who have metastaticcolorectal cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of leucovorin and fluorouracil with or without oxaliplatin with that of capecitabine with or without oxaliplatin in treating patients who have metastatic colorectal cancer.
Details: OBJECTIVES: Primary - Compare the progression-free survival of patients with metastatic colorectal adenocarcinoma treated with leucovorin calcium and fluorouracil with vs without oxaliplatin or capecitabine with vs without oxaliplatin. - Compare the quality of life of patients treated with these fluorouracil-based vs capecitabine-based regimens. Secondary - Compare the failure-free and overall survival of patients treated with these regimens. - Compare the toxic effects and adverse events associated with these regimens in these patients. - Compare the limited health assessments of patients treated with these regimens. - Compare the health economics associated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms and receive 12 weeks of therapy. - Patients receive leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression during or within 8 weeks of the completion of this regimen may cross over and receive second-line therapy on arm II. - Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV over 46 hours beginning on day 1. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression during or within 8 weeks of the completion of this regimen may receive second-line therapy or supportive care off-study. - Patients receive oral capecitabine twice daily on days 1-15. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression during or within 8 weeks of the completion of this regimen may cross over and receive second-line therapy on arm IV. - Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-15. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression during or within 8 weeks of the completion of this regimen may receive second-line therapy or supportive care off-study. All patients are then re-evaluated at least every 6 weeks and begin another 12 weeks of therapy at any evidence (e.g., clinical, radiological, or tumor marker) of disease progression. Patients with chemo-sensitive disease may repeat alternating 12-week therapy sessions and evaluation periods indefinitely. Quality of life is assessed at baseline, at 12-14 weeks, at 24 weeks, and then every 3 months thereafter. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 460 patients (115 per treatment arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of colorectal adenocarcinoma, defined by 1 of the following: - Prior or current histologically confirmed primary adenocarcinoma of the colon or rectum with clinical/radiological evidence of advanced/metastatic disease - Histologically or cytologically confirmed metastatic adenocarcinoma with clinical/radiological evidence of colorectal primary tumor - Unidimensionally measurable disease - Unfit and unsuitable for full-dose combination chemotherapy, which would include 1 of the following circumstances: - Unsuitable or unwilling to be entered into any full-dose chemotherapy protocol - Ineligible or unsuitable for first-line standard combination as per National Institute of Clinical Excellence guidance PATIENT CHARACTERISTICS: Age - Not specified Performance status - WHO 0-2 Life expectancy - Not specified Hematopoietic - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic - Bilirubin no greater than 3 times upper limit of normal (ULN) - AST or ALT no greater than 2.5 times ULN Renal - Creatinine clearance greater than 50 mL/min OR - Glomerular filtration rate greater than 30 mL/min Cardiovascular - No uncontrolled angina - No recent myocardial infarction Other - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - No partial or complete bowel obstruction - No concurrent severe uncontrolled medical illness that would preclude study treatment - No psychiatric or neurological condition that would preclude giving informed consent or complying with oral study medication - No other prior or concurrent malignant disease that would preclude study treatment or assessment of response - No prior neuropathy greater than grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 4 months since prior adjuvant chemotherapy with fluorouracil with or without leucovorin calcium - More than 1 month since prior rectal chemoradiotherapy with fluorouracil with or without leucovorin calcium - No prior systemic palliative chemotherapy for metastatic disease Endocrine therapy - Not specified Radiotherapy - See Chemotherapy Surgery - Not specified Other - No concurrent brivudine or sorivudine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MatthewSeymour, , Cancer Research UK Clinical Centre at St. James's University Hospital
University of Leeds *Recruiting*
Leeds, England, LS2 9JT
United Kingdom
Recruiting Phil Quirke 44-113-233-3412
Medical Research Council Clinical Trials Unit *Recruiting*
London, England, NW1 2DA
United Kingdom
Recruiting Gareth Griffiths 44-20-7670-4704
Velindre Cancer Center at Velinde Hospital *Recruiting*
Cardiff, Wales, CF14 2TL
United Kingdom
Recruiting Alison Brewster 44-29-2031-6220
Cookridge Hospital at Leeds Teaching Hospital NHS Trust *Recruiting*
Leeds, England, LS16 6QB
United Kingdom
Recruiting Matthew Seymour 44-113-392-4307
Additional Information:
Study ID Numbers: CDR0000330142; EU-20303,MRC-CR09,NCRI-FOCUS2
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070213
Other Rectal Cancer Studies:
1. Computed Tomographic Colonography in Detecting Colorectal Polyps or Cancer
2. Screening for Cancer of the Prostate, Lung, Colon, Rectum, or Ovaries in Older Patients
3. Genetic Study of Patients and Families With a History of Colorectal Cancer
4. Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Colorectal Cancer
5. Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy
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Leucovorin and Fluorouracil With or Without Oxaliplatin Compared to Capecitabine With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
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