Clinical trial NCT00276861 (phase 2, status: terminated)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: gemcitabine hydrochloride, oxaliplatin
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed adenocarcinoma of the colon

               -  Metastatic or recurrent disease

               -  Redocumentation of tumor histology or cytology prior to protocol therapy is not
                  required if documented tumor was confirmed prior to initial therapy

          -  Measurable disease

               -  Lesion of ≥ 1 cm in longest diameter that can be repetitively assessed by
                  radiographic measurement or any lesion of ≥ 2 cm in longest diameter that can be
                  repetitively assessed by physical examination

               -  Positive bone scans, osteoblastic or osteolytic bone lesions, pleural effusions,
                  and positive bone marrow biopsies are not considered measurable or evaluable
                  lesions

          -  Metastatic disease to the brain allowed if emergent radiotherapy for symptomatic CNS
             disease is not required

          -  Must have received at least one prior chemotherapy regimen (with or without
             radiotherapy)

               -  One of the prior regimens must include irinotecan hydrochloride, fluorouracil,
                  and leucovorin calcium or irinotecan hydrochloride and other fluoropyrimidine

               -  Previous therapy with C-225 and/or bevacizumab is allowed

          -  .

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Granulocyte count ≥1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Creatinine ≤ 2.0 mg/dL

          -  Bilirubin < 1.5 mg/dL

          -  SGOT ≤ 2 times upper limit of normal (ULN)

          -  Alkaline phosphatase < 2.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No serious medical or psychiatric illness that would render chemotherapy unsafe

          -  No concurrent clinically evident malignancy except inactive nonmelanoma skin cancer,
             low-grade low-stage bladder carcinoma followed off therapy, or lobular neoplasia of
             the breast

          -  No clinical AIDS or known positive HIV serology

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from prior therapy

          -  No investigational agent for at least 30 days prior to study entry

          -  No chemotherapy within the past 3 weeks

          -  No radiotherapy for palliation within the past 2 weeks prior to study entry

          -  No prior oxaliplatin or gemcitabine hydrochloride

          -  No concurrent participation in another clinical trial

          -  No other concurrent anticancer therapy including chemotherapy, radiotherapy, hormonal
             therapy, or immunotherapy

          -  No other concurrent investigational drugs