Phase 3 trial of the antiangiogenic agent thalidomide in patients with malignant mesothelioma after first line chemotherapy.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24002

Enrollment

216

Registered

2006-10-01

Start date

2004-09-09

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stabilisation or response to first line chemotherapy including pemetrexed. Patients randomized in the obeservation arm will only receive best supportive care

Interventions

Thalidomide 200 mg orally at night for up to 1 year with best supportive care or observation alone with best supportive care.

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Inaqdequate measures for birth control; 2. Polyneuropathy > grade 1; 3. Thrombo-embolic events.

Design outcomes

Primary

Measure	Time frame
Increase of 5 to 7.5 moths for time to recurrence.	—

Secondary

Measure	Time frame
Toxicity (neurologic and thrombo-embolic)	—

Contacts

Public ContactD. Storm

The Netherlands Cancer center NVALT Trial Desk Plesmanlaan 121

d.storm@nki.nl+31(0)20 5129111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)