Malignant pleural mesothelioma
Conditions
Interventions
21-Day period as one course.Cisplatin 60mg/m2 and pemetrexed 500mg/m2 on Day1.Repeat for 2-6 courses
Sponsors
Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically proved malignant pleural mesothelioma 2. Patients who were not candidates for curative surgery. 3. Previously treated with chemotherapy drugs except for pemetrexed. 4. Measurable disease 5. Age : >=20 and <75 6. Performance status of 0-1 (ECOG) 7. Treatment area of irradiation <= 25% of hematogenous marrow 8. More than 21days after surgery 9. Adequate organ function listed below. Hb: >=9.0g/dL WBC: >=3,000/mm3 or Neu: >=2,000/mm3 Plt: >=100,000/mm3 AST and ALT: <=2.5times the upper limit of normal T-Bil: <= 1.5times the upper limit of normal Cr: <1.5mg/dL SpO2 (or SaO2): >=92% ECG: normal 10. Patients with an estimated life expectancy of more than 12 weeks 11. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Serious or uncontrolled complication 2. Active infection 3. Active concomitant malignancy 4. Symptomatic brain metastasis 5. With prior unapproved drugs or investigational new drugs 6. With a history of sensitivity to platinum agent, folic acid or vitamin B12 7. Women with confirmed, lactating or suspected pregnancy. Patients who won't avoid pregnancy. 8. Peripheral neuropathy >= grade 2 9. Interstitial pneumonia or fibroid lung 10. Medically endorsed anticonception can't be assured till 90 days after the final administration 11. Inappropriate patients for entry on this trial in the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate Overall survival Incidence of treatment-emergent adverse events | — |
Countries
Japan
Outcome results
None listed