Clinical trial NCT00070122 (phase 3, status: terminated)
Conditions: adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer, stage iii colon cancer, stage iii rectal cancer, stage iv colon cancer, stage iv rectal cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: oxaliplatin, leucovorin calcium, capecitabine, fluorouracil
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: 
    administratively complete.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed locally advanced, recurrent, or metastatic
             colorectal adenocarcinoma

               -  Not curable by surgery or amenable to radiotherapy with curative intent

               -  Previously resected colorectal cancer with new evidence of metastasis does not
                  require separate histologic or cytologic confirmation unless one of the following
                  is true:

                    -  More than 5 years has elapsed between primary surgery and development of
                       metastatic disease

                    -  Primary tumor was T1-T2, N0, M0

          -  Site of primary lesion must be or have been in the large bowel as determined by
             endoscopy, radiology, or surgery

          -  Measurable or evaluable disease

          -  No known brain or leptomeningeal disease

          -  Performance status - Zubrod 0-2

          -  No history of hemorrhagic or thrombotic disorders

          -  Absolute neutrophil count greater than 1,500/mm^3

          -  Platelet count greater than 100,000/mm^3

          -  Bilirubin no greater than 2.0 times upper limit of normal (ULN)

          -  SGOT no greater than 2.5 times ULN (5 times ULN for patients with liver involvement)

          -  Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN for patients with
             liver involvement or 10 times ULN for patients with bone involvement)

          -  INR no greater than 1.5

          -  PTT no greater than ULN

          -  Creatinine no greater than 1.5 times ULN

          -  Creatinine clearance at least 50 mL/min

          -  Proteinuria less than 1+*

          -  Protein less than 500mg/24 hours*

          -  No uncontrolled hypertension

               -  Hypertension must be well-controlled (i.e., less than 160/90) and on a stable
                  regimen of antihypertensive therapy

          -  No unstable angina

          -  No symptomatic congestive heart failure

          -  No myocardial infarction within the past 6 months

          -  No serious uncontrolled cardiac arrhythmia

          -  No New York Heart Association class III or IV heart disease

          -  No symptomatic pulmonary fibrosis

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
             stage I or II cancer currently in complete remission

          -  No active or uncontrolled severe infection

          -  No contraindication to oral medications (e.g., severe dysphagia)

               -  G-tubes or J-tubes allowed

          -  No peripheral neuropathy greater than grade 1

          -  No serious non-healing wound, ulcer, or bone fracture

          -  No significant traumatic injury within the past 28 days

          -  No other severe acute or chronic medical condition or laboratory abnormality that
             would preclude study participation

          -  No psychiatric condition that would preclude study participation

          -  No prior bevacizumab

          -  No prior oxaliplatin

          -  No prior chemotherapy for advanced colorectal cancer

               -  Prior adjuvant therapy for resected stage II-III disease allowed provided at
                  least 12 months have elapsed between completion of therapy and diagnosis of
                  recurrent disease

          -  At least 28 days since prior radiotherapy and recovered

          -  See Disease Characteristics

          -  More than 28 days since prior major surgical procedure or open biopsy

          -  More than 7 days since prior fine needle aspiration or core biopsy

          -  No concurrent major surgery

          -  More than 10 days since prior full-dose aspirin (325 mg)

          -  No concurrent antiplatelet agents (e.g., dipyridamole, ticlopidine, clopidogrel, or
             cilostazol)

          -  No other concurrent investigational agents

          -  No concurrent therapeutic anticoagulation

               -  Prophylactic anticoagulation of central venous lines allowed

               -  Low-dose prophylactic enoxaparin or heparin allowed

          -  No concurrent cimetidine

          -  No concurrent sorivudine or its related analogs (e.g., brivudine)

          -  No concurrent use of a cold cap or iced mouth rinses