Clinical trial NCT00720512 (phase 3, status: terminated)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: fluorouracil, irinotecan hydrochloride, leucovorin calcium, 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, 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:

          -  Histologically confirmed colorectal adenocarcinoma

               -  Metastatic or unresectable disease

          -  Progressive disease based on the following criteria:

               -  Progression during or after first-line chemotherapy for metastatic disease,
                  including any of the following:

                    -  Fluoropyrimidine-based monotherapy with bevacizumab

                    -  Fluoropyrimidine and irinotecan hydrochloride-based doublet with bevacizumab

                    -  Fluoropyrimidine and oxaliplatin-based doublet with bevacizumab

               -  Progression after more than 3 months from the last administration of first-line
                  chemotherapy for metastatic disease with a fluoropyrimidine, irinotecan
                  hydrochloride, and oxaliplatin triplet (FOLFOXIRI) with bevacizumab to which the
                  patient had previously responded

          -  Measurable disease, as assessed by RECIST criteria

          -  No prior or concurrent CNS metastasis

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy > 3 months

          -  ANC ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL

          -  INR ≤ 1.5 times upper limit of normal (ULN)

          -  aPTT ≤ 1.5 ULN

          -  Serum bilirubin ≤ 1.5 times ULN

          -  AST and ALT ≤ 2.5 times ULN (< 5 times ULN if liver metastases present)

          -  Alkaline phosphatase ≤ 2.5 times ULN (< 5 times ULN if liver metastases present)

          -  Serum creatinine ≤ 1.5 times ULN

          -  Proteinuria < 2+ OR protein ≤ 1g by 24-hour urine

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No bowel obstruction or subobstruction

          -  No history of inflammatory enteropathy

          -  No prior extensive intestinal resection (i.e., > hemicolectomy or extensive small
             intestine resection with chronic diarrhea)

          -  No symptomatic peripheral neuropathy > grade 2

          -  No active uncontrolled infection

          -  No active disseminated intravascular coagulation

          -  No prior or concurrent malignancy, except for curatively treated basal cell and
             squamous cell carcinoma of the skin, or in situ carcinoma of the cervix

          -  No clinically significant cardiovascular disease, including any of the following:

               -  Cerebrovascular accident within the past 6 months

               -  Myocardial infarction within the past 6 months

               -  Unstable angina

               -  NYHA class II-IV chronic heart failure

               -  Uncontrolled arrhythmia

          -  No uncontrolled hypertension

          -  No thromboembolic or hemorrhagic events within the past 6 months

          -  No evidence of bleeding diathesis or coagulopathy

          -  No serious, non healing wound/ulcer or serious bone fracture

          -  No significant traumatic injury within the past 28 days

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 6 weeks since prior radiotherapy

          -  At least 4 weeks since prior surgery

          -  No prior first-line chemotherapy for metastatic disease without bevacizumab

          -  No prior cetuximab or other investigational agents

          -  More than 28 days since prior open biopsy

          -  More than 28 days since prior and no concurrent major surgical procedure

          -  No concurrent therapeutic anticoagulation, antiplatelet agents, or NSAID with
             anti-platelet activity

               -  Acetylsalicylic acid ≤ 325 mg/day allowed