Clinical trial NCT03295084 (phase 1, status: completed)
Conditions: metastatic colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: irinotecan, capecitabine
SMILES: CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=CC=CC=C4N=C13)C2=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Signed written Informed Consent

          -  18 years of age or older

          -  Capable of understanding the protocol requirements and risk associated with the study

          -  Patients must have histological confirmed malignancy (solid tumor) that is metastatic
             or unresectable and for which standard curative or palliative measures do not exist or
             are no longer effective

          -  Patients with either measurable disease according to RECIST 1.1 or non-measurable
             disease

          -  Performance status 0-1 (ECOG)

          -  Life expectancy ≥ 3 months

          -  Coagulation INR < 1.3 and APTT within normal limits

          -  WBC ≥ 3000/mm3

          -  Absolute neutrophil count ≥ 1500/mm3

          -  Hemoglobin ≥ 6.0 mmol/L

          -  Platelet count ≥ 100.000/mm3

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

          -  AST and ALT ≤ 2.5 times ULN AST and ALT ≤ 2.5 times ULN. For patients with liver
             metastasis adequate hepatic function is defined by aspartate aminotransferase (AST) ≤
             5 x ULN and alanine aminotransferase ALT ≤ 5 x ULN

          -  No severe or uncontrolled renal condition (creatinine ≤ than 1.5 ULN)

          -  No significant cardiovascular disease (New York Heart Association Class III and IV)

          -  No other severe cardiac condition not defined above

          -  No significant cardiovascular disease (incl. myocardial infarction, unstable angina,
             symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1
             year prior for patients to be enrolled and treated in combination with oral
             capecitabine

          -  No severe or uncontrolled pulmonary condition

          -  No known prior hypersensitivity reaction to irinotecan

          -  No known prior hypersensitivity to capecitabine or 5-fluorouracil for patients to be
             enrolled and treated in combination with oral capecitabine

          -  No chronic enteropathy (e.g. active inflammatory bowel disease, extensive intestinal
             resection or chronic diarrhea)

          -  No bowel obstruction or sub-obstruction

          -  No prior history of intestinal malabsorption

          -  Patients have to be able to swallow normally and have to be willing to comply with the
             intake of tablets

          -  No psychiatric condition that would preclude study participation

          -  No co-existing active infection requiring antibiotics or any co-existing medical
             conditions likely to interfere with study procedures

          -  No other condition that will preclude study participation

          -  A negative pregnancy test for women of childbearing potential. For men and women of
             child-producing potential, the use of effective contraceptives methods during the
             study and at least 3 months after discontinuations of the study drug is required.

          -  Not pregnant or nursing

          -  Peripheral neuropathy NCI CTCAE grade less than 2 for patients to be enrolled and
             treated in combination with oral capecitabine

          -  The patient is willing and able to comply with hospitalization for treatment and
             scheduled follow-up visits and examinations

        Exclusion Criteria:

          -  Simultaneous participation in any other study involving investigational drugs or
             having participated in a study within 4 weeks prior to start of study treatment

          -  Symptomatic brain metastases

          -  Intake of any prohibited concomitant medication

          -  Known Dihydropyrimidine dehydrogenase (DPD) deficiency for patients to be enrolled and
             treated in combination with oral capecitabine.