Clinical trial NCT03300609 (phase 3, status: terminated)
Conditions: colorectal adenocarcinoma, ras wild type, stage iii colorectal cancer ajcc v7, stage iiia colorectal cancer ajcc v7, stage iiib colorectal cancer ajcc v7, stage iiic colorectal cancer ajcc v7, stage iv colorectal cancer ajcc v7, stage iva colorectal cancer ajcc v7, stage ivb colorectal cancer ajcc v7
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: oxaliplatin, leucovorin calcium, fluorouracil, capecitabine
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    insufficient accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Metastatic or locally advanced (unresectable) colorectal cancer with histological
             confirmation of adenocarcinoma (patients with or without measurable disease by imaging
             are eligible)

          -  No prior systemic chemotherapy for metastatic disease; subjects who received adjuvant
             therapy with FOLFOX and at the time of recurrence are at least 6 months away from last
             chemotherapy are eligible for this study

          -  At the time of randomization to maintenance therapy only patients who didn't progress
             by Response Evaluation Criteria in Solid Tumors (RECIST) criteria are eligible;
             patients with complete response (CR) and those who are candidates for resection will
             not be eligible for randomization to maintenance therapy, subjects who undergo surgery
             potentially have curable disease with defined duration of treatment and use of EGFR in
             the adjuvant setting is deemed to be detrimental in these population; likelihood of
             achieving CR is low and standard of care in this unique patient population is not well
             defined

          -  Provide written informed consent

          -  RAS wild-type tumor

          -  Negative serum or urine pregnancy test done =< 7 days prior to registration, for women
             of childbearing potential only

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 or 1

          -  Total serum bilirubin =< institutional upper limit of normal (ULN)

          -  Absolute neutrophil count (ANC) >= 1500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Hemoglobin >= 9.0 g/dL (hemoglobin may be supported by transfusion)

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (=< 5
             x ULN for subjects with liver involvement of their cancer)

          -  Creatinine within institutional limits of normal OR creatinine clearance > 60
             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

          -  Magnesium >= lower limit of normal

          -  Willing to provide tissue and blood samples for mandatory correlative and research
             purposes

        Exclusion Criteria:

          -  Patients who are candidates for upfront metastasectomy (defined as those with limited
             liver metastatic disease) are not eligible for this study; the candidacy for
             resectability can be determined by the treating physician and or local surgeon; in
             ambiguous situations, please discuss the case with the principle investigator (PI)

          -  Known or suspected brain or central nervous system (CNS) metastases

          -  Active, uncontrolled infection, including hepatitis B, hepatitis C

          -  Patients with history of interstitial lung disease/pulmonary fibrosis

          -  Concurrent anti-cancer therapy, including chemotherapy agents, targeted agents, or
             biological agents not otherwise specified in this protocol

          -  Radiation therapy =< 2 weeks prior to randomization

          -  Any of the following

               -  Pregnant or nursing women

               -  Men or women of childbearing potential who are unwilling to employ adequate
                  contraception

          -  Co-morbid systemic illnesses or other severe concurrent disease, history of any
             psychiatric or addictive disorder, or laboratory abnormality, which, in the judgment
             of the investigator, would make the patient inappropriate for entry into this study or
             interfere significantly with the proper assessment of safety and toxicity of the
             prescribed regimens

          -  Patients known to be human immunodeficiency virus (HIV) positive

          -  Uncontrolled intercurrent illness whom in the opinion of the investigator, may
             increase the risks associated with study participation or study treatment, or may
             interfere with the conduct of the study or the interpretation of the study results

          -  Receiving any other investigational agent, which would be considered as a treatment
             for the primary neoplasm

          -  Other active malignancy =< 3 years prior to registration; exceptions are: nonmelanoma
             skin cancer or carcinoma-in-situ of the cervix that has been treated

          -  History of prior malignancy for which patient is receiving other specific treatment
             for their cancer

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to study drugs