Cisplatin Combined With Oral TS-1 in Patients With Advanced Solid Tumors With Different Degrees of Liver Dysfunction

This is an interventional basic science trial for Cancer Read More

Inclusion Criteria:

Patients must fulfill ALL the following inclusion criteria

• Age 18 years.
• Histologic or cytologic diagnosis of carcinoma, that is either refractory to standard therapy or has no available therapies.
• Measurable disease using the RECIST v1.1 criteria
• ECOG performance 0 or 1.
• Estimated life expectancy of at least 12 weeks.
• Adequate bone marrow and renal function as follows:

Bone marrow: Absolute neutrophil count (ANC) 1.5 x 109/L Platelets 100 x 109/L Renal: calculated creatinine clearance >60ml/minute Total bilirubin and AST/ALT as described in Table 1

• Able to swallow pills
• Signed informed consent from patient or legal representative
• Patients with reproductive potential must use an approved contraceptive method if appropriate (e.g., intrauterine device, birth control pills, or barrier device) during and for three months after the study.
• Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.

Exclusion Criteria:

Patients will be excluded from the study for any of the following reasons:

• Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
• Treatment of a small molecule targeted agents ≤ 2 weeks prior to starting study treatment
• Treatment within the last 30 days with any investigational drug.
• Radiotherapy ≤4 weeks prior to starting study treatment or who have not recovered from radiotherapy-related toxicities. Limited field palliative radiotherapy ≤ 2 weeks prior to starting study treatment is allowed
• Major surgery within 28 days of study drug administration.
• History or presence of serious uncontrolled ventricular arrhythmias
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of TS-1 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
• Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory)
• Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
• Pregnancy.
• Breast feeding.
• Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
• Poorly controlled diabetes mellitus.
• Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
• Symptomatic brain metastasis.
• History of significant neurological or mental disorder, including seizures or dementia.