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Home > "C" Clinical Trials Conditions > Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer  Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
For Condition: Colon Cancer,Rectal Cancer
Status: Recruiting
Sponsor(s): Hoffmann-La Roche ,
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. PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastaticcolorectal cancer.
Details: OBJECTIVES: - Determine the overall objective response rate in patients with locally advanced, locally recurrent, or metastatic colorectal cancer treated with capecitabine and irinotecan. - Determine the time to treatment failure, time to overall response, duration of overall complete response, and time to progression in patients treated with this regimen. - Determine the 1-year survival and overall survival of patients treated with this regimen. - Determine the toxicity and safety profile of this regimen in these patients. - Determine the feasibility of predicting responses to this regimen by the molecular profile of tumor tissue in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days 2-15 and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients maintaining a response or stable disease after 12 courses may continue treatment at the discretion of the investigator. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 9 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma - At least 1 measurable lesion - At least 10 mm by spiral CT scan - At least 20 mm by conventional techniques - Bone metastases, ascites, or pleural effusions are not considered measurable disease - No evidence of CNS metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 80-100% Life expectancy: - Not specified Hematopoietic: - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present) - Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present or 10 times ULN if bone metastases present) - No known Gilbert's disease Renal: - Creatinine no greater than 1.5 times ULN - Creatinine clearance at least 50 mL/min Cardiovascular: - No clinically significant cardiac disease - No congestive heart failure - No symptomatic coronary artery disease - No cardiac arrhythmias uncontrolled with medication - No myocardial infarction within the past 12 months Gastrointestinal: - Able to swallow tablets - No lack of physical integrity of the upper gastrointestinal tract - No malabsorption syndrome Other: - No prior unanticipated severe reaction to fluoropyrimidine therapy - No hypersensitivity to fluorouracil - No history of uncontrolled seizures or CNS disorders - No psychological illness or condition that would preclude study entry - No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix - No serious infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 12 months since prior neoadjuvant or adjuvant, active or passive immunotherapy - No concurrent active or passive immunotherapy (e.g., 17-1A antibody) for colon cancer - No concurrent prophylactic hematopoietic growth factors Chemotherapy: - At least 12 months since prior neoadjuvant or adjuvant cytotoxic chemotherapy - No prior chemotherapy for metastatic colorectal cancer - No prior irinotecan or capecitabine - No other concurrent cytotoxic agents Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy - No prior radiotherapy to measurable lesion (newly arising lesions in a previously irradiated area allowed) - No concurrent radiotherapy Surgery: - At least 4 weeks since prior major surgery and recovered - No prior organ allograft Other: - At least 4 weeks since prior participation in an investigational drug study - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DvoritSamid, Study Chair, Hoffmann-La Roche
Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Pam Nylen 800-678-MTRA
Rockwood Clinic P.S. *Recruiting*
Spokane, Washington, 99202
United States
Recruiting Pam Nylen 800-678-MTRA
HemOnCare, P.C. *Recruiting*
Brooklyn, New York, 11235
United States
Recruiting Pam Nylen 800-678-MTRA
Cancer Center at the University of Virginia *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting Pam Nylen 800-678-MTRA
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107-5541
United States
Recruiting Pam Nylen 800-678-MTRA
George Washington University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20037
United States
Recruiting Pam Nylen 800-678-MTRA
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536-0084
United States
Recruiting Pam Nylen 800-678-MTRA
Eastern Connecticut Hematology and Oncology Associates *Recruiting*
Norwich, Connecticut, 06360
United States
Recruiting Pam Nylen 800-678-MTRA
Loma Linda University Cancer Institute at Loma Linda University Medical Center *Recruiting*
Loma Linda, California, 92354
United States
Recruiting Pam Nylen 800-678-MTRA
Charleston Hematology-Oncology, P.A. *Recruiting*
Charleston, South Carolina, 29403
United States
Recruiting Pam Nylen 800-678-MTRA
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Pam Nylen 800-678-MTRA
St. Louis University Hospital Cancer Center *Recruiting*
St. Louis, Missouri, 63110-0250
United States
Recruiting Pam Nylen 800-678-MTRA
West Virginia University Hospitals *Recruiting*
Morgantown, West Virginia, 26506-9300
United States
Recruiting Pam Nylen 800-678-MTRA
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Pam Nylen 800-678-MTRA
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Pam Nylen 800-678-MTRA
Lincoln Medical and Mental Health Center *Recruiting*
Bronx, New York, 10451
United States
Recruiting Pam Nylen 800-678-MTRA
University of Florida Health Science Center - Jacksonville *Recruiting*
Jacksonville, Florida, 32209
United States
Recruiting Pam Nylen 800-678-MTRA
Additional Information:
Study ID Numbers: CDR0000068843; ROCHE-ML16323
Study Start Date:
Record last reviewed: June 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022698
Other Colon Cancer Studies:
1. Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
2. Genetic Study of Patients and Families With a History of Colorectal Cancer
3. Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
4. Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction
5. Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum
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Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
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