Clinical trial NCT00296062 (phase 1, status: terminated)
Conditions: colorectal cancer, unspecified adult solid tumor, protocol specific
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: capecitabine, irinotecan hydrochloride, oxaliplatin
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    trial did not move to phase ii portion due to poor tolerance of treatment
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Phase I:

               -  Histologically or cytologically confirmed solid tumor

                    -  Metastatic OR locally advanced unresectable disease

                    -  No curative therapy exists

               -  Measurable or evaluable disease

                    -  Measurable disease is defined as ≥ 1 lesion that can be accurately measured
                       in ≥ 1 dimension as ≥ 20 mm with conventional techniques OR ≥ 10 mm with
                       spiral CT scan

               -  No known brain metastases

          -  Phase II:

               -  Histologically or cytologically confirmed colorectal cancer

                    -  Metastatic OR locally advanced unresectable disease

               -  Measurable disease (as defined in phase I)

               -  No tumor involving major blood vessels

               -  No evidence of CNS disease, including primary brain tumor or brain metastases

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 70-100%

          -  Life expectancy ≥ 12 weeks

          -  Absolute neutrophil count (ANC) ≥ 1,500/mm^3

               -  ANC < 1,500/mm^3 allowed, if in the opinion of the investigator, this represents
                  an ethnic or racial variation of normal

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin > 10.0 g/dL

          -  Bilirubin ≤ 1.5 mg/dL

          -  AST/ALT ≤ 2 times upper limit of normal (ULN)

          -  Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min

          -  Urine protein:creatinine ratio < 1.0 OR protein < 1 g by 24-hour urine collection
             (phase II)

          -  PT/INR ≤ 1.5 unless on full-dose anticoagulants (phase II)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile female patients must use effective double-barrier contraception during and for
             28 days (phase I) or 3 months (phase II) after completion of study treatment

          -  Fertile male patients must use effective contraception during and for 6 months after
             completion of study treatment

          -  No history of allergic reaction attributed to compounds of similar chemical or
             biologic composition to capecitabine, irinotecan hydrochloride, oxaliplatin, or
             bevacizumab

          -  No other uncontrolled illness including, but not limited to, any of the following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness or social situation that would preclude study compliance

          -  No cardiac ischemia within the past 6 months (phase I)

          -  No New York Heart Association class II-IV congestive heart failure or symptomatic
             arrhythmia (phase II)

          -  No arterial thrombotic events within the past 6 months including, but not limited to,
             any of the following (phase II):

               -  Transient ischemic attack

               -  Cerebrovascular accident

               -  Unstable angina or angina requiring surgical or medical intervention

               -  Myocardial infarction

          -  No clinically significant peripheral vascular disease (phase II)

          -  No history of hypertension unless well controlled (< 150/90 mm Hg) on an
             antihypertensive regimen (phase II)

          -  No evidence of bleeding diathesis or coagulopathy (phase II)

          -  No gastrointestinal (GI) perforation, abdominal fistula, or intra-abdominal abscess
             within the past 30 days (phase II)

          -  No significant history of bleeding events (phase II)

               -  Patients with a history of significant bleeding episodes (e.g., hemoptysis or
                  upper or lower GI bleeding) within the past 6 months are not eligible unless the
                  source of bleeding has been resected

          -  No significant traumatic injury within the past 28 days (phase II)

          -  No serious or nonhealing wound, ulcer, or bone fracture (phase II)

          -  No peripheral neuropathy > grade 1

        PRIOR CONCURRENT THERAPY:

          -  At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
             (phase I)

          -  At least 2 weeks since prior immunotherapy or biologic therapy and recovered (phase I)

          -  No prior treatment for advanced or metastatic colorectal cancer (phase II)

          -  More than 12 months since prior adjuvant chemotherapy and/or biologic therapy (e.g.,
             bevacizumab or cetuximab) and recovered (phase II)

          -  At least 4 weeks since prior radiotherapy and recovered

          -  No prior radiotherapy to the only site of measurable disease unless there is
             measurable disease progression within the radiation port after completion of
             radiotherapy

          -  No prior radiotherapy to ≥ 20% of the bone marrow

          -  More than 28 days since prior major surgical procedure* or open biopsy and recovered
             (phase II)

          -  More than 14 days since prior minor surgery* and recovered (phase II)

          -  Concurrent full-dose anticoagulation (e.g., warfarin) allowed provided the following
             criteria are met (phase II):

               -  Patient has an in-range INR (between 2 and 3) and is on a stable dose of oral
                  anticoagulants or a stable dose of low molecular weight heparin

               -  No active bleeding or pathological condition that carries a high risk of bleeding
                  (e.g., known varices)

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational agents

          -  No concurrent sargramostim (GM-CSF) NOTE: *Insertion of a vascular device is not
             considered major or minor surgery