Cetuximab and Capecitabine in Treating Patients With Metastatic Colorectal Cancer That Failed Irinotecan Treatment
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: cetuximab; capecitabine; gene expression analysis; microarray analysis; polymorphism analysis; reverse transcriptase-polymerase chain reaction; immunohistochemistry staining method
Intervention MeSH terms: Capecitabine; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent colon cancer; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer

Summary:

      RATIONALE: Monoclonal antibodies such as cetuximab, can block tumor growth in different ways.
      Some block the ability of tumor cells to grow and spread. Others find tumor cells and help
      kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of
      colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as
      capecitabine, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving cetuximab together with capecitabine may kill
      more tumor cells.

      PURPOSE: This phase II trial is studying how well giving cetuximab together with capecitabine
      work in treating patients with metastatic colorectal cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of metastatic colorectal cancer

          -  Measurable disease

          -  Disease progression during prior fluoropyrimidine-containing therapy comprising
             irinotecan with or without oxaliplatin

               -  Received standard first- and second-line irinotecan and oxaliplatin-based therapy

                    -  Patients who completed 1 prior treatment for metastatic disease but refused
                       standard second-line therapy are eligible

               -  Patients who's disease progressed within 6 months of previous therapy are
                  eligible

          -  EGFR negative patients allowed

          -  No untreated or uncontrolled brain metastasis

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Absolute neutrophil count ≥ 1,500/μL

          -  Platelet count ≥ 100,000/μL

          -  ALT ≤ 5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 5 times ULN

          -  Serum creatinine ≤ 1.5 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other prior malignancy within the past 5 years except nonmelanoma skin cancer or
             carcinoma in situ of the cervix

          -  No serious intercurrent infections or medical problems

          -  No active or uncontrolled infections

          -  No significant history of uncontrolled cardiac disease, including any of the
             following:

               -  Uncontrolled hypertension

               -  Unstable angina

               -  Myocardial infarction within the past 6 months

               -  Uncontrolled congestive heart failure

               -  Cardiomyopathy with decreased ejection fraction

          -  No prior severe infusion reaction to a monoclonal antibody

          -  No known dihydropyrimidine dehydrogenase deficiency or evidence of past
             hypersensitivity to fluoropyrimidine

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No more than 2 prior treatments for metastatic colorectal cancer

          -  More than 2 weeks since prior therapy

          -  Prior radiotherapy allowed if < 30% of bone marrow involvement

          -  No other concurrent investigational agents

          -  No concurrent highly active antiretroviral therapy for HIV-positive patients

          -  No prior therapy that specifically and directly targets the EGFR pathway