Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum
Eligibility 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 therapy with 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
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
- Eastern Connecticut Hematology and Oncology Associates
- Lombardi Cancer Center at Georgetown University Medical Center
- George Washington University Medical Center
- University of Florida Health Science Center - Jacksonville
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- St. Louis University Hospital Cancer Center
- Lincoln Medical and Mental Health Center
- HemOnCare, P.C.
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center
- Charleston Hematology-Oncology, P.A.
- Cancer Center at the University of Virginia
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Rockwood Clinic P.S.
- West Virginia University Hospitals
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cohort 1,Initial Regimen:(Capecitabine + Irinotecan )
Cohort 2,Amended Regimen:(Capecitabine + Irinotecan)
Participants will receive capecitabine (Xeloda) 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discretion of the investigator, participants who are responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Participants will receive capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discretion of the investigator, participants who will be responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).