No registrations found.
ID
Source
Brief title
Health condition
Stabilisation or response to first line chemotherapy including pemetrexed.
Patients randomized in the obeservation arm will only receive best supportive care
Sponsors and support
Thalidomide is prepared by Prof J Beijnen farmacist, the Slotervaart hospital
Intervention
Outcome measures
Primary outcome
Increase of 5 to 7.5 moths for time to recurrence.
Secondary outcome
Toxicity (neurologic and thrombo-embolic)
Background summary
In a phasee 2 study of patients with progressive mesothelioma, 27% showed stabilization of disease for more than 6 months. Therefore a phase 3 randomized study was developed to investigate the true gain of daily thalidomide in patients who have had no signs of progression of the disease after standard first line therapy. The hypothesis is that thalidomide is able to delay the revascularization of mesotheliomas. These are known for their high expression of VEGF and worse prognosis when a high vessel density is observed.
Study objective
Maintenance thalidomide delays the time to progression with 50% in patients who do not progress after > 3 cycles of pemetrexed containing chemotherapy.
Intervention
Thalidomide 200 mg orally at night for up to 1 year with best supportive care
or observation alone with best supportive care.
NVALT Trial Desk
Plesmanlaan 121
D. Storm
Amsterdam 1066 CX
The Netherlands
+31(0)20 5129111
d.storm@nki.nl
NVALT Trial Desk
Plesmanlaan 121
D. Storm
Amsterdam 1066 CX
The Netherlands
+31(0)20 5129111
d.storm@nki.nl
Inclusion criteria
1. Good condition (PS 0-2);
2. First line therapy with pemetrexed minimum of 4 courses;
3. A measurable lesion is not required;
4. Normal laboratory values;
5. Signed informed consent;
6. Thalidomide therapy to start within 9 weeks after last chemotherapy course.
Exclusion criteria
1. Inaqdequate measures for birth control;
2. Polyneuropathy > grade 1;
3. Thrombo-embolic events.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL786 |
| NTR-old | NTR798 |
| Other | : N/A |
| ISRCTN | ISRCTN13632914 |