Randomized Phase II Study of Trastuzumab and Pertuzumab Compared to Cetuximab and Irinotecan in Advanced Metastatic Colorectal Cancer with HER-2 Amplification

April 9, 2020

Clinical Trial Information

Schema S1613

PROTOCOL: SWOG-S1613

Please note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

  1. Patients must have histologically or cytologically documented adenocarcinoma of the colon or rectum that is metastatic or locally advanced and unresectable.
  2. All patients must have molecular testing performed in a CLIA certified lab which includes KRAS and NRAS gene and exon 15 of BRAF gene (BRAF V600E mutation). Patients with any known activating mutation in exon 2 [codons 12 and 13], exon 3 [codons 59 and 61] and exon 4 [codons 117 and 146]) of KRAS/NRAS genes and in exon 15 (BRAFV600E mutation) of BRAF gene are not eligible.
  3. Patients must not have been treated with any of the following prior to Step 1 Initial Registration:
    1. • Cetuximab, or any other monoclonal antibody against EGFR or inhibitor of
      EGFR.
      • HER-2 targeting for treatment of colorectal cancer. Patients who have received
      prior trastuzumab or pertuzumab for other indications such as prior history of
      adjuvant or neoadjuvant breast cancer treatment prior to the development of
      advanced colorectal cancer are eligible.
  4. Patients must not have had history of severe toxicity and intolerance to or hypersensitivity to irinotecan or any other study drug. Patients must not have had a severe infusion-related reaction during any prior therapy with pertuzumab or trastuzumab.
  5. Patients must have HER-2 amplification as determined by central testing (3+ or 2+by immunohistochemistry and HER-2 gene amplification by in situ hybridization with a ratio of HER-2 gene signals to centromere 17 signals ≥ 2.0).
  6. Patients must have measurable disease that is metastatic or locally advanced and unresectable.
  7. Patients must have had at least one prior regimen of systemic chemotherapy for metastatic or locally advanced, unresectable disease. Patients must have progressed following the most recent therapy. Prior treatment with irinotecan is allowed. For patients that received adjuvant chemotherapy: Prior treatment for metastatic disease is not required for patient who experienced disease recurrence
    during or within 6 months of completion of adjuvant chemotherapy. If the patient received one line of adjuvant treatment and had disease recurrence after 6 months of completing chemotherapy, patients will only be eligible after failing one additional line of chemotherapy used to treat the metastatic or locally advanced, unresectable disease. Patients who have received ≥3 lines of systemic
    chemotherapy for metastatic or locally advanced, unresectable disease are not eligible.
  8. Patients must have a Zubrod Performance Status of 0 or 1.
  9. Patients must be ≥ 18 years of age.

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