NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program - Protocol Summary

Alliance A021502 - "RANDOMIZED TRIAL OF STANDARD CHEMOTHERAPY ALONE OR COMBINED WITH ATEZOLIZUMAB AS ADJUVANT THERAPY OF PATIENTS WITH STAGE III COLON CANCER WITH DEFICIENT DNA MISMATCH REPAIR"

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please follow the "Full Protocol" link or contact NCORP-KC for complete protocol information.



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GI Clinical Trial

CANCER TYPE: Colon
RESEARCH BASE: Alliance
NCT NUMBER: NCT02912559
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM

BRIEF DESCRIPTION

Colon, Stage III, deficient DNA mismatch repair, completely resected,  mFOLFOX6 +/- Atezolizumab.  DCP-001 Eligible



NOTES


Treatment Plan         (Supplied Drug:  Atezolizumab)

Arm 1:  mFOLFOX6 (12 cycles) Plus Atezolizumab (25 cycles)

Atezolizumab 840mg IV Day 1

Oxaliplatin 85mg/m2 IV Day 1

Leucovorin 400mg/m2 IV Day 1

Fluorouracil 400mg/m2 IV Day 1  +  2400mg/m2 IV Days 1-3

 

Arm 2:  mFOLFOX6 (12 cycles)

Oxaliplatin 85mg/m2 IV Day 1

Leucovorin 400mg/m2 IV Day 1

Fluorouracil 400mg/m2 IV Day 1  +  2400mg/m2 IV Days 1-3

 

1 Cycle = 14 days

 



ELIGIBILITY

Eligibility

  • 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.
  • FFPE tumor tissue is required for subsequent retrospective central confirmation of dMMR status.
  • Tumors must have been completely resected.
  • Entire tumor must be in the colon (rectal involvement is an exclusion).
  • No evidence of residual involved lymph node disease or metastatic disease at the time of registration based on clinician assessment of imaging.
  • No prior medical therapy (chemotherapy, immunotherapy, biologic or targeted therapy) or radiation therapy for colon cancer except for one cycle of mFOLFOX6.
  • Age ≥ 18 years
  • ECOG Performance Status ≤ 2
  • Not Pregnant and Not Nursing
  • Required Initial Laboratory Values:
    • Absolute Neutrophil Count (ANC) ≥ 1500 mm3
    • Platelet Count ≥ 100,000 mm3*
    • Creatinine ≤ 1.5 x upper limit of normal (ULN) or Calculated Creatinine Clearance ≥ 45 mL/min
    • Total Bilirubin ≤ 1.5 x upper limit of normal (ULN)
    • AST / ALT ≤ 2.5 x upper limit of normal (ULN)
    • TSH is WNL
  • 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.
  • Excluded if known active pulmonary disease with hypoxia
  • No grade ≥ 2 peripheral motor or sensory neuropathy.
  • Patients positive for HIV are eligible only if they meet all of the following:
    • A stable regimen of highly active anti-retroviral therapy (HAART)
    • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
    • A CD4 count above 250 cells/mcL, and an undetectable HIV viral load on standard PCR-based tests
  • 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 CHO cell products or any component of the atezolizumab formulation.
  • No known allergy to 5-fluorouracil, oxaliplatin, or leucovorin.





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