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Home > "C" Clinical Trials Conditions > Comparison of Adjuvant Combination Chemotherapy Regimens in Treating Patients With Resected Stage III Colon Cancer  Comparison of Adjuvant Combination Chemotherapy Regimens in Treating Patients With Resected Stage III Colon Cancer
Comparison of Adjuvant Combination Chemotherapy Regimens in Treating Patients With Resected Stage III Colon Cancer
For Condition: stage 3 colon cancer,adenocarcinoma of the colon
Status: 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 chemotherapy drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapyregimen is more effective after surgery in treating stage III colon cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of three adjuvant combination chemotherapy regimens in treating patients who have resected stage III colon cancer.
Details: OBJECTIVES: - Compare the overall survival of patients with curatively resected stage III colon cancer when treated with adjuvant irinotecan vs oxaliplatin with fluorouracil and leucovorin calcium vs both regimens given consecutively. - Compare the disease-free survival of patients treated with these regimens. Secondary - Compare the toxic effects of these regimens in these patients. - Determine the quality of life, measures of patient satisfaction, nutrition, and cancer risk in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to positive lymph node involvement (1-3 vs 4 or more) and histology (high [poorly differentiated or undifferentiated] vs low [well to moderately differentiated]). Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on day 1. Treatment repeats every 2 weeks for up to 12 courses in the absence of unacceptable toxicity or recurrent disease. - Arm II: Patients receive irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm I. Treatment repeats every 2 weeks for up to 12 courses in the absence of unacceptable toxicity or recurrent disease. - Arm III: Patients receive the same treatment as in arm I for 6 courses followed by the same treatment as in arm II for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease. Quality of life is assessed at baseline, before course 6, and at the end of therapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for up to 3 years. PROJECTED ACCRUAL: A total of 3,750 patients (1,250 per treatment arm) will be accrued for this study within 3.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the colon - Stage III disease - No rectal cancer - Gross inferior (caudad) margin of the primary tumor must be 12 cm from the anal verge by rigid proctoscopy - Tumor must have been completely resected within the past 56 days - Must have documented en bloc resection in patients with tumor adherence to adjacent structures - Tumor-related obstructions and colonic perforation are allowed - At least 1 pathologically confirmed positive lymph node - No evidence of residual involved lymph node disease - Synchronous primary colon cancer allowed - No distant metastatic disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count lower limit of normal - Platelet count 100,000/mm^3 Hepatic - Bilirubin upper limit of normal (ULN) Renal - Creatinine 1.5 times ULN Cardiovascular - No uncontrolled high blood pressure - No unstable angina - No symptomatic congestive heart failure - No myocardial infarction with the past 6 months - No New York Heart Association class III or IV heart disease Pulmonary - No symptomatic pulmonary fibrosis - No symptomatic interstitial pneumonitis Immunologic - No active uncontrolled bacterial, viral, or fungal infection - HIV negative - No clinically defined AIDS Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No grade 2 pre-existing peripheral sensory or motor neuropathy - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or lobular carcinoma in situ in 1 breast - No other concurrent medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent biologic therapy - No concurrent routine prophylactic colony-stimulating factors - No concurrent oprelvekin Chemotherapy - No prior chemotherapy for colon cancer - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for colon cancer Surgery - See Disease Characteristics Other - No concurrent ketoconazole or other potent inhibitors of CYP3A4 (e.g., itraconazole or voriconazole) - No other concurrent anticancer therapy - No concurrent targeted agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenAlberts, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Steven Alberts 507-284-2511
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212-4772
United States
Recruiting Jane Raymond 412-359-6147
Allan Blair Cancer Centre *Recruiting*
Regina, Saskatchewan, S4T 7T1
Canada
Recruiting Muhammad Salim 306-766-2203
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54301
United States
Recruiting Anthony Jaslowski 920-884-3135
CCOP - Atlanta Regional *Recruiting*
Atlanta, Georgia, 30342-1701
United States
Recruiting Thomas Seay 404-851-2340
CentraCare Health Plaza *Recruiting*
St. Cloud, Minnesota, 56303
United States
Recruiting Harold Windschitl 320-229-5199
Medcenter One Health System *Recruiting*
Bismark, North Dakota, 58501-5505
United States
Recruiting Edward Wos 701-323-5741
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-544-1013
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Daniel Nikcevich 218-786-3625
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
Altru Cancer Center *Recruiting*
Grand Forks, North Dakota, 58201
United States
Recruiting Todor Dentchev 701-780-6363
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting Mark Olsen 918-499-2000
Additional Information:
Study ID Numbers: CDR0000355132; NCCTG-N0147
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079274
Other Stage 3 Colon Cancer Studies:
1. SU011248 in Treating Patients With Metastatic Colorectal Adenocarcinoma (Cancer) That Has Not Responded to Previous Treatment With Irinotecan, Oxaliplatin, and a Fluoropyrimidine With or Without Bevacizumab
2. Vaccine Therapy in Treating Patients With Stage II or Stage III Colon Cancer That has Been Removed During Surgery
3. Genetic Study in Patients With Stage II or Stage III Colon Cancer
4. Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer
5. BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Related Studies:
Other stage 3 colon cancer Clinical Trials
Other South Dakota Clinical Trials
Other Sioux Falls Clinical Trials
Comparison of Adjuvant Combination Chemotherapy Regimens in Treating Patients With Resected Stage III Colon Cancer
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