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A 2x2 (4-way) randomized phase 3 study of capecitabine in combo w/ oxaliplatin (XELOX) w/ or without bevacizumab vs. fluorouracil/leucovorin w/ oxaliplatin (FOLFOX-4) w/ or without bevacizumab as first-line treatment for patients w/ metastatic colorectal cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about A 2x2 (4-way) randomized phase 3 study of capecitabine in combo w/ oxaliplatin (XELOX) w/ or without bevacizumab vs. fluorouracil/leucovorin w/ oxaliplatin (FOLFOX-4) w/ or without bevacizumab as first-line treatment for patients w/ metastatic colorectal cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A 2x2 (4-way) randomized phase 3 study of capecitabine in combo w/ oxaliplatin (XELOX) w/ or without bevacizumab vs. fluorouracil/leucovorin w/ oxaliplatin (FOLFOX-4) w/ or without bevacizumab as first-line treatment for patients w/ metastatic colorectal cancer Clinical research trials and A 2x2 (4-way) randomized phase 3 study of capecitabine in combo w/ oxaliplatin (XELOX) w/ or without bevacizumab vs. fluorouracil/leucovorin w/ oxaliplatin (FOLFOX-4) w/ or without bevacizumab as first-line treatment for patients w/ metastatic colorectal cancer medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like A 2x2 (4-way) randomized phase 3 study of capecitabine in combo w/ oxaliplatin (XELOX) w/ or without bevacizumab vs. fluorouracil/leucovorin w/ oxaliplatin (FOLFOX-4) w/ or without bevacizumab as first-line treatment for patients w/ metastatic colorectal cancer. A 2x2 (4-way) randomized phase 3 study of capecitabine in combo w/ oxaliplatin (XELOX) w/ or without bevacizumab vs. fluorouracil/leucovorin w/ oxaliplatin (FOLFOX-4) w/ or without bevacizumab as first-line treatment for patients w/ metastatic colorectal cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a A 2x2 (4-way) randomized phase 3 study of capecitabine in combo w/ oxaliplatin (XELOX) w/ or without bevacizumab vs. fluorouracil/leucovorin w/ oxaliplatin (FOLFOX-4) w/ or without bevacizumab as first-line treatment for patients w/ metastatic colorectal cancer clinical trial. Test subjects typically obtain the finest healthcare available for their A 2x2 (4-way) randomized phase 3 study of capecitabine in combo w/ oxaliplatin (XELOX) w/ or without bevacizumab vs. fluorouracil/leucovorin w/ oxaliplatin (FOLFOX-4) w/ or without bevacizumab as first-line treatment for patients w/ metastatic colorectal cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.

Home > "A" Clinical Trials Conditions > A 2x2 (4-way) randomized phase 3 study of capecitabine in combo w/ oxaliplatin (XELOX) w/ or without bevacizumab vs. fluorouracil/leucovorin w/ oxaliplatin (FOLFOX-4) w/ or without bevacizumab as first-line treatment for patients w/ metastatic colorectal cancer

A 2x2 (4-way) randomized phase 3 study of capecitabine in combo w/ oxaliplatin (XELOX) w/ or without bevacizumab vs. fluorouracil/leucovorin w/ oxaliplatin (FOLFOX-4) w/ or without bevacizumab as first-line treatment for patients w/ metastatic colorectal cancer



A 2x2 (4-way) randomized phase 3 study of capecitabine in combo w/ oxaliplatin (XELOX) w/ or without bevacizumab vs. fluorouracil/leucovorin w/ oxaliplatin (FOLFOX-4) w/ or without bevacizumab as first-line treatment for patients w/ metastatic colorectal cancer

For Condition: Colorectal Cancer
Status: Recruiting
Sponsor(s): Hoffmann-La Roche ,
Synopsis: There are two primary purposes of the study. One is to show that the combination of capecitabine plus oxaliplatin (XELOX) with or without bevacizumab is at least as effective as the combination of fluorouracil/leucovorin (5-FU/LV) plus oxaliplatin (FOLFOX-4) with or without bevacizumab in terms of time to tumor progression or death in patients with metastatic colorectal cancer, who have not received previous treatment for metastatic disease. The other is to show that bevacizumab in combination with chemotherapy (XELOX or FOLFOX-4) is better than chemotherapy alone in the same patient population.
Details:
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Men or women (outpatients) at least 18 years old with good performance status - Histologically confirmed cancer of the colon or rectum with metastatic disease - Must have measurable tumors - Life expectancy of at least 3 months - Informed consent Exclusion Criteria: - No previous anti-cancer treatment for metastatic disease - No previous oxaliplatin or bevacizumab. (Certain allowances included for previous radiotherapy or surgery for metastatic disease, adjuvant treatment allowed with if completed at least 6 months ago, and disease not progressed during or within 6 months.) - Women who are pregnant or breast-feeding (including, if of childbearing potential, with a positive or no pregnancy test) - Sexually active men and women (of childbearing potential) unwilling to practice contraception during treatment - History of another cancer within the last five years, except basal cell skin cancer or cancer of cervix - Ascites (abdominal fluid) - Serious non-healing wound, ulcer or bone fracture - Bleeding or coagulation problems - Regular use of aspirin, NSAIDs, blood thinners - Central nervous system disease - Psychiatric disease - Clinically significant cardiovascular disease within the last year - Gastrointestinal problems such as poor absorption of nutrients or inability to digest tablets - Certain forms of pneumonia or lung disease - Peripheral neuropathy - Organ transplants - Serious uncontrolled infections - Moderate or severe kidney disease - Certain laboratory values - Prior unanticipated severe reaction to fluoropyrimidine therapy - Known DPD deficiency - Allergy to platinum compounds or study medications - Received another experimental drug or procedure in the past 4 weeks - Had major surgery within 4 weeks - Not completely recovered from major surgery - Need for surgery during the study
Total Enrollment: 

Location and Contact Information:


Additional Information:
Study ID Numbers:  NO16966; 
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069095

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A 2x2 (4-way) randomized phase 3 study of capecitabine in combo w/ oxaliplatin (XELOX) w/ or without bevacizumab vs. fluorouracil/leucovorin w/ oxaliplatin (FOLFOX-4) w/ or without bevacizumab as first-line treatment for patients w/ metastatic colorectal cancer
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