Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: panitumumab; erlotinib hydrochloride; irinotecan hydrochloride
Intervention description: Given intravenously 6mg/kg every 2 weeks; Given orally 150mg daily; Given intravenously 120mg/m2 for 6/6 genotype and 60mg/m2 for 6/7 genotype
Intervention MeSH terms: Irinotecan; Erlotinib Hydrochloride; Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
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: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the
      enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, 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. Panitumumab
      may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used
      in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth
      of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet
      known whether erlotinib hydrochloride given together with panitumumab is more effective with
      or without irinotecan in treating patients with metastatic colorectal cancer.

      PURPOSE: This randomized phase II trial is studying giving erlotinib hydrochloride together
      with panitumumab to see how well it works with or without irinotecan hydrochloride as
      second-line therapy in treating patients with metastatic colorectal cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed colorectal cancer

               -  Metastatic disease

                    -  Biopsy of either the primary cancer or metastatic site required

               -  Tumor expressing wild-type Kras mutations

          -  Progressive disease within 3 months after treatment with first-line fluorouracil
             (5-FU) and oxaliplatin-based chemotherapy OR evidence of metastatic disease within 6
             months of completing adjuvant therapy with 5-FU and oxaliplatin

          -  Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1
             dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques OR
             as ≥ 10 mm with spiral CT scan

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy > 6 months

          -  ANC > 1,500/mm^3

          -  Platelet count > 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL

          -  Creatinine < 1.5 times upper limit of normal (ULN)

          -  Bilirubin < 1.5 times ULN (or < 2 mg/dL)

          -  AST and/or ALT < 3 times ULN (< 5 times ULN with liver metastases)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No concurrent malignancy requiring therapy except minor surgery for non-melanoma skin
             cancer removal

          -  No interstitial lung disease with symptoms (e.g., dyspnea or cough) including any of
             the following significant conditions:

               -  Parenchymal lung disease

               -  Metastatic disease

               -  Pulmonary infections

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior EGFR inhibitors, irinotecan hydrochloride, or other second-line chemotherapy
             regimens

          -  More than 4 weeks since prior radiotherapy

          -  No other concurrent investigational agents

          -  No other concurrent anticancer treatment modalities (e.g., radiotherapy)