Clinical trial NCT00640081 (phase 2, status: completed)
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:

               -  Prior or current histologically confirmed primary adenocarcinoma of colon or
                  rectum with clinical or radiological evidence of advanced and/or metastatic
                  disease

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

          -  Unidimensionally measurable disease by RECIST criteria

          -  Inoperable metastatic or locoregional disease

               -  Potentially resectable liver metastases allowed provided the following criteria
                  are met:

                    -  Fewer than 4 unilobar liver metastases, each < 4 cm in size and without
                       major vascular involvement

                    -  No combination chemotherapy allowed prior to the planned resection of
                       operable liver metastases

          -  No confirmed K-ras mutation of tumor after screening

          -  No brain metastases

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-2

          -  Must be considered fit to undergo combination chemotherapy

          -  ANC ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Serum bilirubin ≤ 1.25 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 5 times ULN

          -  AST or ALT ≤ 2.5 times ULN

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

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No severe uncontrolled concurrent medical illness (including poorly controlled angina
             or myocardial infarction within the past 12 weeks) likely to interfere with protocol
             treatments

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

          -  No partial or complete bowel obstruction

          -  No preexisting neuropathy > grade 1

          -  No prior or current malignant disease which, in the judgement of the treating
             investigator, is likely to interfere with COIN-B treatment or assessment of response

          -  No patients with known hypersensitivity reactions to any of the components of the
             study treatments

          -  No proven dihydropyrimidine dehydrogenase deficiency (DPD) or personal or family
             history of DPD

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior systemic palliative chemotherapy for metastatic disease

          -  No prior oxaliplatin

          -  More than 1 month since prior adjuvant chemotherapy comprising fluorouracil (with or
             without leucovorin calcium), capecitabine, or irinotecan hydrochloride

          -  More than 1 month since prior chemoradiotherapy comprising fluorouracil (with or
             without leucovorin calcium) or capecitabine for rectal cancer

          -  No ongoing requirement for contraindicated concurrent medication

          -  No concurrent enrollment in any type of study other than observational studies