Panitumumab and Irinotecan as Third-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: 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. Drugs used in chemotherapy, such as
      irinotecan, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving panitumumab together with irinotecan may kill
      more tumor cells.

      PURPOSE: This phase II clinical trial is studying giving panitumumab together with irinotecan
      to see how well it works as third-line therapy in treating patients with metastatic
      colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess the objective response rate when panitumumab is administered in combination
           with irinotecan hydrochloride as third-line therapy in patients with advanced metastatic
           colorectal cancer without KRAS mutation (wild type) previously treated with FOLFOX or
           XELOX chemotherapy with or without bevacizumab and irinotecan hydrochloride alone or
           FOLFIRI or CAPIRI chemotherapy with or without bevacizumab.

      Secondary

        -  To assess the efficacy in terms of disease control rate, duration of response, time to
           response, progression-free survival, time to progression, time to treatment failure, and
           duration of stable disease.

        -  To assess the efficacy and safety of this regimen, followed by panitumumab alone in
           patients who discontinue third-line irinotecan hydrochloride due to toxicity.

      Tertiary

        -  To correlate this regimen with EGFR expression, detection of the functional genetic
           polymorphisms of the EGFR gene, EGFR gene amplification (FISH), EGFR activation
           detection, EGFR downstream protein and gene expression parameters, proteomics, and
           epigenetics.

      OUTLINE: This is a multicenter study.

      Patients receive panitumumab IV over 30-90 minutes and irinotecan hydrochloride IV over 90
      minutes on day 1. Patients who discontinue irinotecan hydrochloride may receive panitumumab
      monotherapy. Courses repeat every 14 days in the absence of disease progression and
      unacceptable toxicity.

      Archived tumor tissue specimens are obtained at baseline for correlative laboratory studies.
      Tissue samples are analyzed for EGFR amplification status by chromogenic in situ
      hybridization and fluorescence in situ hybridization, KRAS and KRAF mutations, and STAT3
      expression.

      After completion of study therapy, patients are followed at approximately 56 days.
    

Intervention name(s): Panitumumab; Irinotecan hydrochloride; Chromogenic in situ hybridization; Fluorescence in situ hybridization; Gene expression analysis; Laboratory biomarker analysis
Intervention type(s): Drug; Drug; Genetic; Genetic; Genetic; Other
Intervention description(s): 6 mg/kg; 180 mg/kg
Other intervention name(s): Vectibix; Camptosar
Intervention MeSH terms: Irinotecan; Panitumumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the colon; adenocarcinoma of the rectum; stage IV colon cancer; recurrent rectal cancer; stage IV rectal cancer; recurrent colon cancer