Clinical trial NCT00056030 (phase 2, status: completed)
Conditions: colorectal cancer, metastatic cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: fluorouracil, leucovorin calcium, oxaliplatin
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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  History of completely resected primary adenocarcinoma of the colon or rectum

               -  No gross or microscopic evidence of residual disease

          -  Liver metastases, meeting 1 of the following criteria:

               -  Not optimally resectable

               -  Requires resection of all 3 major hepatic veins, the portal vein bifurcation, or
                  the retrohepatic vena cava

               -  Includes the main right or main left portal vein and the main hepatic vein of the
                  opposite lobe

               -  Requires more than a right or left trisegmentectomy

               -  At least 6 metastatic lesions distributed diffusely in both lobes of the liver

          -  Measurable disease

               -  At least 1 measurable lesion ≥ 20 mm

          -  No evidence of extrahepatic metastases by physical examination or x-ray

          -  No previously resected extrahepatic metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Hemoglobin ≥ 9 g/dL

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

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  AST ≤ 3 times upper limit of normal (ULN)

          -  Bilirubin ≤ ULN

          -  No preexisting chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis)
             that would preclude surgical resection of metastases

        Renal

          -  Creatinine ≤ 1.5 times ULN

        Cardiovascular

          -  No myocardial infarction within the past 6 months

          -  No clinical evidence of congestive heart failure

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

          -  No significant cardiac disease

          -  No uncontrolled hypertension

          -  No unstable angina

          -  No congestive heart failure

          -  No uncontrolled arrhythmias

        Gastrointestinal

          -  Adequate oral nutrition with estimated caloric intake of ≥ 1,500 calories/day

          -  No severe anorexia or frequent nausea and/or vomiting

          -  No history of gastrointestinal bleeding that has not been appropriately addressed

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Able to tolerate major surgery

          -  No prior allergic reaction or known sensitivity to chimerized or murine monoclonal
             antibody therapy

          -  No documented presence of human anti-mouse antibodies

          -  No known allergy to other platinum compounds

          -  No other malignancy within the past 5 years except basal cell or squamous cell skin
             cancer, carcinoma in situ, or tumors associated with less than 10% probability of
             death within 5 years of diagnosis

          -  No preexisting neuropathy ≥ grade 2

          -  No symptomatic pulmonary fibrosis or interstitial pneumonitis

          -  No uncontrolled bacterial or viral infection

          -  HIV negative

          -  No fungal infection

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No colony-stimulating factors within 24 hours of day 1 of each course

          -  No concurrent immunotherapy

        Chemotherapy

          -  At least 1 year since prior adjuvant systemic fluorouracil with or without levamisole
             or with or without leucovorin calcium

          -  No prior oxaliplatin

          -  No prior systemic chemotherapy for metastatic disease

          -  No prior chemoembolization for metastatic disease

          -  No prior hepatic artery infusion chemotherapy for metastatic disease

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  At least 12 months since prior adjuvant radiotherapy

          -  Prior radiofrequency ablation allowed

          -  No prior radiotherapy to the liver

          -  No prior radiotherapy to more than 25% of the bone marrow

          -  No concurrent radiotherapy

        Surgery

          -  See Disease Characteristics

          -  More than 21 days since prior abdominal exploration (with or without intestinal
             resection)

        Other

          -  No prior anti-EGFR-directed therapy

          -  Prior cryotherapy allowed

          -  No oral cryotherapy on day 1 of each course