Clinical trial NCT00209612 (phase 1/phase 2, status: withdrawn)
Conditions: gastric cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: taxol, campt, topotesin
SMILES: [H][C@]12[C@H](OC(=O)C3=CC=CC=C3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)C4=CC=CC=C4)C4=CC=CC=C4)C(C)=C([C@@H](OC(C)=O)C(=O)[C@]1(C)[C@@H](O)C[C@H]1OC[C@@]21OC(C)=O)C3(C)C, CCC1=C2CN3C(=CC4=C(COC(=O)[C@]4(O)CC)C3=O)C2=NC2=CC=C(OC(=O)N3CCC(CC3)N3CCCCC3)C=C12
Reason stopped: 
    due to strong side effect
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed metastatic or recurrent gastric cancer with prior treatment
             for advanced disease.

          -  Patients who have received 1cycle cancer therapy (radiotherapy, chemotherapy or
             chemoradiotherapy) given > 4 weeks prior to the beginning of study therapy

          -  At least one measurable lesion according to the RECIST criteria. Minimum indicator
             lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional
             techniques(Except for Phase I setting).

          -  Patients aged between 20 and 75 years, inclusive, at the time of acquisition of
             informed consent

          -  Patients with performance status(ECOG) 0 to 2

          -  Abnormal hematologic values (WBC ≥ 3.5 x 109/L, Hemoglobin ≥ 9.0g/dl, platelet count ≥
             100 x 109/L)

          -  Serum cleatinine ≤ 1.5mg/dl

          -  Serum bilirubin ≤ 1.5mg/dl. ALT, AST ≤ 2.0 x upper normal limit (or ≤ 3 x upper normal
             limit in the case of liver metastases)

          -  Normal ECG

          -  Life expectancy ≥ 3 months

          -  Patients who have given written informed consent to participate in this study

        Exclusion Criteria:

          -  Patients with active multiple cancers; or even if the multiple cancers are
             metachronous, have a disease-free period of less than 5 years (but excluding cancer in
             situ and skin cancer) (Except for Phase I setting)

          -  Serious, uncontrolled, concurrent infection(s) or illness(es)

          -  Patients with no serious concurrent complications (such as heart disease, Intestinal
             pneumonia)

          -  Patients with Liver cirrhosis

          -  Patients with fresh hemorrhage from the gastrointestinal tract

          -  Patients with poorly controlled diabetes or are treated by continuous use of insulin

          -  Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have
             difficulties participating in the study

          -  Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion)
             necessitating treatment

          -  Patients with diarrhea (watery stool)

          -  Patients with infection, intestinal palsy or intestinal occlusion

          -  Patients with brain metastasis

          -  Patients with Gilbert syndrome

          -  Patients who have experienced serious drug allergy in the past

          -  Patients who are pregnant and lactating or hope to become pregnant during the study
             period

          -  Patients with prior Taxan (Paclitaxel, Docetaxel) or CPT-11 treatment

          -  Patients with neuropathy ≥ grade 2

          -  Others, patients judged by the investigator or subinvestigator to be inappropriate as
             subject