Clinical trial NCT00182715 (phase 3, status: unknown status)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: capecitabine, fluorouracil, leucovorin calcium, oxaliplatin
SMILES: [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, 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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of colorectal adenocarcinoma, defined by 1 of the following:

               -  Histologically confirmed primary adenocarcinoma of the colon or rectum with
                  clinical or radiological evidence of advanced and/or metastatic disease

               -  Histologically or cytologically confirmed metastatic adenocarcinoma with clinical
                  or radiological evidence of primary colorectal tumor

          -  Unidimensionally measurable disease

          -  Inoperable metastatic or locoregional disease

               -  Ineligible for hepatic resection after first-line combination chemotherapy

          -  No brain metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  WHO 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

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

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Bilirubin ≤ 1.25 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 5 times ULN

          -  AST or ALT ≤ 2.5 times ULN

        Renal

          -  Creatinine clearance or glomerular filtration rate ≥ 50 mL/min

        Cardiovascular

          -  No poorly controlled angina

          -  No myocardial infarction within the past 3 months

        Other

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Must be considered fit to undergo combination chemotherapy

          -  No psychiatric or neurological condition that would preclude study compliance or
             giving informed consent

          -  No partial or complete bowel obstruction

          -  No other malignant disease that would preclude study treatment

          -  No preexisting neuropathy > grade 1

          -  No known hypersensitivity reaction to any of the components of study drugs

          -  No known DPD deficiency or personal or family history suggestiv of DPD deficiency

          -  No other severe uncontrolled medical illness that would preclude study treatment

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior systemic palliative chemotherapy for metastatic disease

          -  No prior oxaliplatin

          -  More than 1 month since prior adjuvant fluorouracil (5-FU) (with or without leucovorin
             calcium), capecitabine, or irinotecan

          -  More than 1 month since prior rectal chemoradiotherapy with 5-FU (with or without
             leucovorin calcium) or capecitabine

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Chemotherapy

        Surgery

          -  Not specified

        Other

          -  No concurrent brivudine or sorivudine (for patients receiving capecitabine on study)