Phase 2 study of cisplatin and pemetrexed in previously treated patients with malignant pleural mesothelioma

UMIN ID: UMIN000000965

Registered date:04/01/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Malignant pleural mesothelioma
• Date of first enrollment: 2008/01/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 21-Day period as one course.Cisplatin 60mg/m2 and pemetrexed 500mg/m2 on Day1.Repeat for 2-6 courses

Outcome(s)

• Primary Outcome: Progression-free survival

Secondary Outcome

Response Rate
Overall survival
Incidence of treatment-emergent adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female

Exclude 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.

Related Information

• Primary Sponsor: Hyogo College of Medicine

Source(s) of Monetary Support

Japan Science and Technology Agency
Ministry of Education, Culture, Sports, Science and Technology