Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Capecitabine; Irinotecan
Intervention MeSH terms: Capecitabine; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

Summary:

      PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan
      in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.
    

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