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Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

Official Title: Oxaliplatin (NSC 266046) in Combination With 5-Fluorouracil and Leucovorin (FOLFOX4) for Patients Who Have Not Received Prior Chemotherapy for Advanced Colorectal Cancer

Study ID: NCT00039611

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Clinical trial to study the effectiveness of combination chemotherapy in treating patients who have advanced colorectal cancer.

Detailed Description: OBJECTIVES: * Provide oxaliplatin in combination with fluorouracil and leucovorin calcium using the FOLFOX4 regimen for front-line treatment in patients with no prior chemotherapy for advanced colorectal cancer who are not eligible for entry into ongoing clinical trials of higher priority. (The regimen in this Treatment Referral Center protocol is one that was found to be superior in a recent national intergroup study.) * Further determine the safety of this regimen in these patients. * Further determine the anti-tumor activity of this regimen, defined as the rate of time-to-treatment failure, time to progression, and survival, in these patients. * Capture data on subsequent salvage therapy administered to patients treated with this protocol. OUTLINE: This is an open-label, multicenter study. Patients receive oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on days 1 and 2, and fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients with clinical evidence of benefit from this treatment, defined as stable disease, partial response, or complete response as well as no increase in size of any measurable or evaluable lesion and no new sites of disease, may be eligible for additional courses. Patients are followed until death. PROJECTED ACCRUAL: A maximum of 300 patients per month will be accrued for this study.

Eligibility

Minimum Age: 15 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Anchorage Oncology Centre, Anchorage, Alaska, United States

Mayo Clinic Scottsdale, Scottsdale, Arizona, United States

University of California San Diego Cancer Center, La Jolla, California, United States

Yale Comprehensive Cancer Center, New Haven, Connecticut, United States

Mayo Clinic, Jacksonville, Florida, United States

Atlanta Cancer Care, Atlanta, Georgia, United States

Cancer Center of Kansas - Wichita, Wichita, Kansas, United States

Louisiana State University School of Medicine, New Orleans, Louisiana, United States

Cancer Therapy Evaluation Program, Bethesda, Maryland, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

St. Vincent Hospital and Health Center, Billings, Montana, United States

Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States

Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States

Ireland Cancer Center, Cleveland, Ohio, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Huntsman Cancer Institute, Salt Lake City, Utah, United States

Virginia Mason Medical Center, Seattle, Washington, United States

Contact Details

Name: S. Percy Ivy, MD

Affiliation: NCI - Investigational Drug Branch

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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