Phase II Trial of Lapatinib & Capecitabine for Patients With Refractory Advanced Colorectal Adenocarcinoma
Condition: Metastatic Colorectal Cancer
MeSH terms: Adenocarcinoma
Intervention: lapatinib; Capecitabine
Intervention description: 1250mg by mouth daily one hour before or after breakfast on a continuous basis.; 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
Intervention MeSH terms: Capecitabine; Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out how effective this combination is as a second line
      treatment for colorectal cancer that has spread from one part of the body to another
      (metastasized) or has not metastasized but is considered inoperable (unable to be removed by
      surgery). The side effects and survival experienced by subjects receiving these drugs will
      also be evaluated. This is a phase II research study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  Pathologically confirmed, locally advanced or metastatic adenocarcinoma of the colon
             or rectum

          -  Patients must have had progression of disease on prior therapy with an
             oxaliplatin-containing or irinotecan containing regimen

          -  Proper radiographic documentation of measurable disease using RECIST criteria

          -  ECOG performance status (PS) of 0 or 1

          -  Laboratory parameters:

        Hgb: ≥ 9.0 g/dl ANC ≥ 1500/ul Platelet ≥ 100,000/ul Creatinine ≤ 2x ULN OR Creatinine
        clearance ≥ 30 mg/ml Bilirubin ≤ 2x ULN AST ≤ 2x ULN or 5X ULN if liver metastases are
        present

          -  Patient has signed informed consent

          -  Toxicities from prior therapy (except alopecia and neuropathy) must have resolved to
             grade 1 or better prior to enrollment

        Exclusion Criteria:

          -  Administration of more than one prior systemic chemotherapy for metastatic disease

          -  Pregnant or breast-feeding women: female patients must agree to use effective
             contraception, must be surgically sterile, or must be postmenopausal. Male patients
             must agree to use effective contraception or be surgically sterile. The definition of
             effective contraception will be based on the judgment of the principal investigator or
             a designated associate. All at-risk female patients must have a negative serum
             pregnancy test within 7 days prior to randomization.

          -  Active inflammatory bowel disease, significant bowel obstruction, or chronic diarrhea
             (grade 2).

          -  Known human immunodeficiency virus (HIV) positivity or
             acquired-immunodeficiency-syndrome (AIDS)-related illness.

          -  No previous or concurrent malignancy is allowed except for adequately treated basal
             cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer for which
             the patient has been disease-free for 3 years.

          -  Known CNS metastases

          -  Prior therapy which specifically and directly targets the EGFR pathway

          -  Significant history of uncontrolled cardiovascular disease, defined as:

               -  History of uncontrolled or symptomatic angina

               -  History of arrhythmias requiring medications, or clinically significant, with the
                  exception of asymptomatic atrial fibrillation requiring anticoagulation

               -  Myocardial infarction < 6 months prior to study entry

               -  Cerebrovascular accident <6 months prior to study entry

               -  Uncontrolled or symptomatic congestive heart failure

               -  Ejection fraction below the institutional normal limit

               -  Any other cardiac condition, which in the opinion of the treating physician,
                  would make this protocol unreasonably hazardous for the patient