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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
Overall Recruitment Status: Active, currently enrolling
 
Official Title
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
 
Region Sponsors
Colorado
National Cancer Institute (NCI)
 
Acronym KP IRB No.
CO-17-2486
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Colon Adenocarcinoma; DNA Repair Disorder; Lynch Syndrome; Stage III Colon Cancer AJCC v7; Stage IIIA Colon Cancer AJCC v7; Stage IIIB Colon Cancer AJCC v7; Stage IIIC Colon Cancer AJCC v7;
 
Purpose
This randomized phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with colon cancer.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Histologically proven stage III colon adenocarcinoma (any T [Tx, T1, T2, T3, or T4], N1-2M0 includes N1C)
  • 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. Formalin-fixed paraffin-embedded (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 polymerase chain reaction (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
  • Tumors must have been completely resected. In patients with tumor adherent to adjacent structures, en bloc R0 resection must be documented. Positive radial margins are not excluded as long as en bloc resection was performed. Proximal or distal margin positivity is excluded
  • Absolute neutrophil count (ANC) >= 1500 mm^3
  • Platelet count >= 100,000 mm^3
  • platelets >= 75,000 required for patients who received cycle 1 of mFOLFOX6 prior to registration
  • Contact site personnel for more study details
 
Exclusion Criteria
  • 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
  • No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for colon cancer except for one cycle of mFOLFOX6
  • 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
  • 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
  • No known history of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins
  • No known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component of the atezolizumab formulation
  • No known allergy to 5-fluorouracil, oxaliplatin, or leucovorin
  • Contact site personnel for more study details

 
Keywords and/or Specific Medical Conditions
  • Colon Cancer
  • Oncology (Adult)
 
KP Clinical Facility
  • Franklin Medical Offices - Denver
  • Lone Tree Medical Offices - Lone Tree
  • Rock Creek Medical Offices - Lafayette
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Alex R Menter, MD
Contact Information:
- Patricia L Bourie
-303-649-5281
-Patricia.L.Bourie@kp.org
-Lone Tree Medical Offices - Lone Tree


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