MATES: Maintenance Thalidomide in Mesothelioma Patients. A phase III trial of anti-angiogenic agent Thalidomide in patients with malignant pleural mesothelioma after first line chemotherapy.
MATES: A phase III trial of anti-angiogenic agent Thalidomide in patients with unresectable malignant mesothelioma who are not progressing after first line therapy compared to no additional treatment after chemotherapy to assess the effectiveness of Thalidomide using time to progression.
University of Sydney
100 participants
May 1, 2009
Interventional
Conditions
Summary
Malignant pleural mesothelioma is a tumour in the lining outside of the lung. This type of tumour is closely linked to exposure to asbestos fibres. The purpose of this study is to determine if treatment with thalidomide for people with malignant pleural mesothelioma will delay the time until the disease gets worse and also if it will keep people feeling better. Thalidomide was originally used as a sedative during pregnancy in the late 1950s, with detrimental effects on the embryo. However since then, it has been found that thalidomide may delay tumour growth in people with mesothelioma. The formation of new blood vessels (angiogenesis), plays an important role in tumour growth and spread. Thalidomide stops or delays the formation of new blood vessels (anti-angiogenic effect), which may prevent or slow down the return of cancer. The research is being done because it is not clear if treatment with thalidomide after treatment with pemetrexed can offer better results than the usual care, which is to have no further chemotherapy treatment after treatment with pemetrexed.
Eligibility
Inclusion Criteria8
- Histologically or cytologically proven diagnosis of malignant mesothelioma of the pleura or peritoneum.
- Presence of at least one target lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > or = 20mm with conventional techniques or as > or = 10 mm with spiral computed tomography (CT) scan.
- Chemotherapy, containing the antifolate (pemetrexed), is required with at least stabilisation or response (Partial response (PR) or Complete Response (CR)) of the disease with a tleast 4 courses of therapy.
- Women of childbearing age must have a negative pregnancy test or must have adequate contraception during the study and for 3 months after cessation of thalidomide.
- Prior surgery or radiotherapy is allowed as long as there was evidence of progression.
- All cytotoxic therapies should be stopped at least 2 weeks before randomisation.
- Palliative radiotherapy to painful lesions or to prevent the development of metastases along biopsy tracks is allowed.
- Performance status according to Eastern Cooperative Oncology Group- World Health Organisation (ECOG WHO) < or = 2 (After palliative measures like pleural drainage)
Exclusion Criteria7
- Pre-existing = grade II sensory neuropathy.
- Severe cardiac, pulmonary, metabolic or other serious co-morbid condiotions.
- Pregnant or lactating women are excluded.
- Life expectancy of < 3 months.
- Uncontrolled infections.
- Prior treatment with thalidomide.
- A period of > or = 6 weeks after the end of chemotherapy treatment.
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Interventions
Addition of Thalidomide 6 weeks after the end of first line chemotherapy, involving antifolate (pemetrexed) with or with out platinum combination (4-6 Cycles). Thalidomide will be administered daily until disease progression or a maximim of 1 year. Patients randomised to receive thalidomide will be treated with thalidomide 100 mg (Starting dose) nightly for the first two weeks. If there are no severe side effects the dose will be increased to 200mg nightly. The mode of administration is oral.
Locations(1)
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ACTRN12609000141246