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April 9, 2020 Colorectal

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

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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April 9, 2020 Colorectal

Phase III Randomized Study of mFOLFOX6/Bevacizumab Combination Chemotherapy with or without Atezolizumab or Atezolizumab Monotherapy in First-Line Treatment of Patients with Deficient DNA Mismatch Repair Metastatic Colorectal Cancer (COMMIT)

Clinical Trial Information

SCHEMA NRG-GI004

PROTOCOL: NRG-GI004

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

ELIGIBILITY:

  1. Age ≥ 18 years.
  2. ECOG Performance Status of 0, 1 or 2.
  3. Diagnosis of metastatic adenocarcinoma of colon or rectum without previous chemotherapy or any other systemic therapy for metastatic colorectal cancer.
  4. Tumor determined to be mismatch-repair deficient (dMMR).
  5. Documentation by PET/CT scan, CT scan, or MRI that the patient has untreated measurable metastatic disease.
  6. No immediate need for surgical intervention for the primary tumor or palliative diversion/bypass.
  7. Patients with CNS metastases are excluded, with the following exceptions. Patients with asymptomatic untreated CNS metastases may be enrolled, provided all eligibility criteria are met, as well as the following:
    1. Evaluable or measurable disease outside the CNS.
    2. No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm).
    3. No history of intracranial hemorrhage or spinal cord hemorrhage.
    4. No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted.
    5. No neurosurgical resection or brain biopsy within 28 days prior to randomization.
  8. Patients with asymptomatic treated CNS metastases may be enrolled, provided all eligibility criteria are met, as well as the following:
    1. Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.
    2. No stereotactic radiation or whole-brain radiation within 28 days prior to randomization.
    3. Screening CNS radiographic study ≥ 28 days from completion of radiotherapy and ≥ 14 days from discontinuation of corticosteroids.
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April 9, 2020 Colorectal

Phase III Randomized Double-Blind Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer

Clinical Trial Information

SCHEMA A021703

PROTOCOL: Alliance-A021703

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

ELIGIBILITY:

  1. Histologically confirmed locally advanced/metastatic colorectal adenocarcinoma with no planned metastasectomy.
  2. No dMMR or MSI-H disease.
  3. – Measurable disease.
  4. No prior systemic treatment for metastatic disease.
  5. Prior neoadjuvant or adjuvant chemotherapy/radiation allowed if completed > 12 months prior to colorectal cancer recurrence.
  6. Prior rectal chemoradiation permitted if radiotherapy was to ≤ 25% of bone marrow and completed ≥ 4 weeks prior to registration.
  7. No continuous daily vitamin D ≥ 2,000 IU/day for the 12 months prior to registration.
  8. Major surgery/open biopsy completed ≥ 4 weeks and/or minor surgery/core biopsy completed ≥ 1 weeks prior to registration.
  9. Age ≥ 18 years; ECOG PS: 0-1.
  10. No resectable metastatic disease for which potentially curative metastasectomy is planned.
  11. No “currently active” second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ.
  12. Concurrent use of calcium, vitamin D, thiazide diuretics, oral corticosteroids, or other anti-cancer therapy not permitted
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April 8, 2020 Colorectal

Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair

Clinical Trial Information

SCHEMA

PROTOCOL: Alliance-A021502

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

ELIGIBILITY:

  1. Histologically proven stage III colon adenocarcinoma.
  2. Presence of deficient MMR (dMMR) via IHC.
  3. Completely resected tumors.
  4. Entire tumor in colon.
  5. No evidence of residual involved lymph node disease or metastatic disease.
  6. Patients known to have Lynch Syndrome are eligible.
  7. No other planned concurrent investigational agents or other tumor directed therapy.
  8. Age ≥ 18 years.
  9. ECOG PS≤ 2.
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