Phase 3 trial of the antiangiogenic agent thalidomide in patients with malignant mesothelioma after first line chemotherapy.
Completed
- Conditions
- Stabilisation or response to first line chemotherapy including pemetrexed.Patients randomized in the obeservation arm will only receive best supportive care
- Registration Number
- NL-OMON24002
- Lead Sponsor
- VALT
- Brief Summary
only on phase 2 study by P Baas et al 2005 Lung Cancer
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 216
Inclusion Criteria
1. Good condition (PS 0-2);
2. First line therapy with pemetrexed minimum of 4 courses;
Exclusion Criteria
1. Inaqdequate measures for birth control;
2. Polyneuropathy > grade 1;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increase of 5 to 7.5 moths for time to recurrence.
- Secondary Outcome Measures
Name Time Method Toxicity (neurologic and thrombo-embolic)