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Research & Trial Information

SCHEMA S1613

Protocol #: S1613

Cancer Type: GI Colorectal Metastatic

ELIGIBILITY CRITERIA:

Step 1 Initial Registration: HER-2 Testing

  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:

    • Cetuximab, panitumumab, 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 tumor slides available for submission for HER-2 testing. HER-2 testing must be completed by the central lab.

    Step 2 Randomization:

    1. Results of HER-2 testing will be available on the SWOG Specimen Tracking Website and sites will be notified by e-mail within 14 calendar days from submission of the tissue specimen to the central lab.

2. 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).

3. Patients must have measurable disease that is metastatic or locally advanced and unresectable. Imaging used to assess all disease per RECIST 1.1 must have been completed within 28 days prior to Step 2 Randomization.

4. 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.

5. Patients must have completed prior chemotherapy, immunotherapy, or radiation therapy at least 14 days prior to Step 2 Randomization and all toxicity must be resolved to CTCAE v4.0 Grade 1 (with the exception of CTCAE v4.0 Grade 2 neuropathy) prior to Step 2 Randomization.

6. Brain metastases are allowed if they have been adequately treated with radiotherapy or surgery and stable for at least 30 days prior to Step 2 Randomization. Eligible patients must be neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to Step 2 Randomization.

7.  Patients must have a Zubrod Performance Status of 0 or 1.

8. Patients must be ≥ 18 years of age.

9.  No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ, other low grade lesions such as incidental appendix carcinoid, or any other cancer from which the patient has been disease and treatment free for two years. Prostate cancer patients on active surveillance are eligible.

 

 



Research & Trial Information

SCHEMA A021502

Protocol #: A021502

Cancer Type: GI Colorectal

Eligibility Criteria:

  1. Histologically proven stage III colon adenocarcinoma (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C). Tumors must be deemed to originate in the colon including tumors that extend into/involve the small bowel (e.g. those at the ileocecal valve).

    DNA Mismatch Repair (MMR) Status: Presence of deficient (d) DNA mismatch repair (dMMR). MMR status must be assessed by immunohistochemistry (IHC) for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR.

    dMMR may be determined either locally or by site-selected reference lab.

    Note: loss of MLH1 and PMS2 commonly occur together.

    FFPE tumor tissue is required for subsequent retrospective central confirmation of dMMR status.

    Patients with testing that did not show dMMR (loss of MMR protein) are not eligible to participate. Patients whose tumors show MSI-H by PCR-based assay are not eligible to participate unless they also have MMR testing by IHC and are found to have dMMR (i.e. loss of one or more MMR proteins).

    Patients who are known to have Lynch Syndrome and have been found to carry a specific germline mutation in an MMR gene (MLH1, MSH2, MSH6, PMS2) are eligible to participate.

  2. Tumors must have been completely resected. In patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented in the operative report or otherwise confirmed by the surgeon. Near or positive radial margins are acceptable so long as en bloc resection was performed. Proximal or distal margin positivity is not permitted.

    Entire tumor must be in the colon (rectal involvement is an exclusion). Surgeon confirmation that entire tumor was located in the colon is required only in cases where it is important to establish if the tumor is a colon vs. rectal primary.

    Based upon the operative report and other source documentation, the location of the primary tumor will be categorized as proximal or distal to the splenic flexure (distal includes), and further categorization will be as follows: cecum/ascending, descending, sigmoid colon, or rectosigmoid colon.

    No evidence of residual involved lymph node disease or metastatic disease at the time of registration based on clinician assessment of imaging. The treating physician will determine if incidental lesions on imaging require workup to exclude metastatic disease. If based on review of images, the treating physician determines the patient to be stage III, then the patient is eligible.

  3. No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for the current colon cancer except for one cycle of mFOLFOX6.
  4. Age ≥ 18 years.
  5. No active known autoimmune disease, including colitis, inflammatory bowel disease (i.e. ulcerative colitis or Crohn’s disease), rheumatoid arthritis, panhypopituitarism, adrenal insufficiency.

    No known active hepatitis B or C.

  6. No other planned concurrent investigational agents or other tumor directed therapy (chemotherapy, radiation) while on study.

    No systemic daily treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of registration.

  7. No known history of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins.

    No known hypersensitivity to CHO cell products or any component of the atezolizumab formulation.

    No known allergy to 5-fluorouracil, oxaliplatin, or leucovorin.

 


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