Clinical trial NCT00498225 (phase 3, status: completed)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: gemcitabine plus ts-1, ts-1, gemcitabine
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
Eligibility criteria:

        Inclusion Criteria:

          -  Pancreatic carcinoma histologically determined to be adenocarcinoma or adenosquamous
             carcinoma.

          -  Advanced unresectable pancreatic (including pancreatic cancer with local progression
             and recurrent pancreatic cancer).Presence/absence of measurable lesions is not
             considered. Patients with measurable lesions must undergo diagnostic imaging tests
             within 28 days before registration.

          -  Patients with no previous treatment (radiotherapy,chemotherapy etc) for pancreatic
             cancer, except resection. Intra-operative radiotherapy during resection of pancreatic
             cancer will be permitted, although registration must occur at least 4 weeks after the
             radiotherapy. Patients that have undergone preoperative/postoperative adjuvant
             chemotherapy may be enrolled if relapse is diagnosed beyond week 24 after the final
             administration (on day 169 when the day following the final day is set as day 1).

          -  Age: 20 years to 79 years.

          -  ECOG Performance Status (PS) of 0 or 1.

          -  Sufficient function of major organs as defined below. (The following criteria are
             satisfied in laboratory tests conducted within 14 days before registration. Laboratory
             tests conducted 2 weeks before registration (on the same weekday) will be included.)
             White blood cell count≥ 3500/mm3 Neutrophil count≥ 2000/mm3 Hemoglobin≥9.0 g/dL
             Platelet count≥100000/mm3 Total bilirubin≤ 2.0 mg/dL* *≤ 3.0 mg/dL in patients treated
             by biliary drainage for obstructive jaundice. AST and ALT≤ 150 U/L Serum
             creatinine≤1.2 mg/dL Creatinine clearance≥50mL/min.** **Measured values will be used
             if available. Otherwise, values calculated by the Cockcroft-Gault method will be
             used.Formula for estimation:body weight (kg) x [140 - age (years) / 72 x serum
             creatinine (mg/dL)] *Estimated value will be multiplied by 0.85 for females.

          -  Able to take capsules orally.

          -  No clinically abnormal ECG findings within 28 days (4 weeks)before registration.

          -  Voluntarily signed the written consent form.

        Exclusion Criteria:

          -  Pulmonary fibrosis or interstitial pneumonia (to be confirmed by chest X-ray within 28
             days before enrollment).

          -  Watery diarrhoea.

          -  Active infections (e.g. patients with pyrexia of 38°C or greater), excluding viral
             hepatitis.

          -  Serious complications (e.g. heart failure, renal failure,hepatic failure, haemorrhagic
             peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled
             diabetes).

          -  Moderate or severe (requiring drainage) ascites or pleural effusion requiring
             treatment.

          -  Metastasis in the CNS.

          -  Active double cancer (synchronous double cancer or asynchronous double cancer with
             disease-free duration of 3 years or less). Carcinoma in situ and lesions of
             intramucosal carcinoma will not be included in active double cancer and will be
             permitted for registration.

          -  Patients under treatment with flucytosine, phenytoin or warfarin potassium.

          -  Pregnant females, possibly pregnant females, females wishing to become pregnant and
             nursing mothers. Males that are currently attempting to produce a pregnancy.

          -  Severe mental disorder.

          -  Judged ineligible by physicians for participation in the study from a safety
             viewpoint.