Clinical trial NCT00155883 (phase 2, status: terminated)
Conditions: gastric cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: taxteral, 5-fluorouracil, leucovorin
SMILES: FC1=CNC(=O)NC1=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    slow a accrul due to many competitive trials.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Histologically proven and inoperable advanced gastric adenocarcinoma.

          2. Bi-dimensionally measurable disease by physical examination or image study
             (roentgenogram or computed tomography scan). The index lesions should be at least 20
             mm × 10 mm in size.

          3. Age must be older than 18 and younger than 75 year-old.

          4. Karnofsky performance status>60% (see Appendix)

          5. Adequate bone marrow reserves, defined as white blood cell (WBC)>4,000/l, absolute
             neutrophil count (ANC)>1,500/l, platelet>100,000/l.

          6. Liver transaminases <2.5 times upper normal limit if no liver metastasis and 5 times
             upper normal limit if liver metastasis is present; total bilirubin <1.5 mg/dl; serum
             creatinine<1.5mg/dl.

          7. Serum triglyceride level>70mg/dl.

          8. Previous chemotherapy for metastatic disease is not allowed in this study. Previous
             adjuvant chemotherapy following curative gastrectomy is acceptable if the adjuvant
             chemotherapy has been completed for more than 6 months before enrollment into the
             present study.

          9. Previous radiotherapy is allowed if the treatment was completed at least 4 weeks
             before the enrollment into this study.

         10. Patients of childbearing age should have effective contraception during the study
             period.

         11. All patients must be informed of the investigational nature of this study and must
             sign and give written informed consent in accordance with institutional guidelines.

        Exclusion Criteria:

          1. Patients who are receiving concurrent radiotherapy, chemotherapy or other experimental
             therapy.

          2. Patients who refuse port-A catheter implantation.

          3. Patients with brain or leptomeningeal metastases.

          4. Patients who have significant cardiac arrhythmia or acute myocardial infarction within
             6 months before entry.

          5. Patients who have major systemic diseases that the attending physicians considered
             inappropriate for systemic chemotherapy.

          6. Life expectancy of less than 2 months.

          7. Pregnant or nursing women may not participate. Women or men with reproductive
             potential may not participate unless they have agreed to use an effective
             contraceptive method.

          8. No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancers, in situ cervical cancer, adequately treated
             stage I or II cancer from which the patient is currently in complete remission, or any
             cancer from which the patient has been disease-free for 5 years.