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Clinical Trial Details
Research Study Summary
A clinical trial to evaluate treatments using Milataxel for patients with Mesothelioma
Research Study Title
A Phase II Study of Milataxel (TL139) Administered Orally in Patients With Malignant Mesothelioma
Milataxel is a new taxane that may have several advantages over the currently available
taxanes. The current study is designed to determine the response rate of oral Milataxel in
patients with malignant Mesothelioma. The study specifically targets patients who have
recurring or progressive disease following previous chemotherapy.
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Both Male and Female
Both Male and Female ages 18 Years and up
Patients must have histologically or cytologically confirmed malignant mesothelioma
for which they have received pemetrexed in combination with cisplatin as part of
Prior cancer therapy with pemetrexed/cisplatin must have been completed at least 30
days prior to the first cycle of milataxel; prior radiotherapy (less than 25% of the
bone marrow) must have been completed at least 30 days prior to study enrollment.
Patients must have measurable disease by the Modified RECIST criteria
Patients must have a life expectancy of at least 12 weeks and an ECOG performance
status of 0, 1 or 2
Patients must be 18 years of age.
Patients must have adequate organ and system function.
Patients must be able to comply with the protocol treatments and procedures.
Patients with known brain metastases may be included in the study, providing they are
Recovered from all acute toxicities caused by prior cancer therapies, except for
Patients must not have received any other chemotherapeutic treatment for malignant
mesothelioma other than pemetrexed and a platinum agent such as cisplatin.
Patients with grade 2 or greater peripheral neuropathy.
Prior cancer therapies not completed within 30 days prior to the first cycle of
milataxel; radiotherapy completed less than 30 days prior to study enrollment;
patients not recovered from radiation-related toxicities; patients receiving any
concurrent anti-cancer therapy, including trastuzumab, bevacizumab or an
investigational agent while on-study; patients with greater than 2 prior radiotherapy
Patients with known sensitivity to alcohol.
Patients with significant intercurrent illnesses.
Patients with symptomatic CNS metastases.
Patients who have had major surgery within the past 14 days.
Patients who require or are likely to require any strong modifier of CYP450 activity
to be taken prior to milataxel administration
Patients who are receiving high dose steroids (more than a dexamethasone-equivalent
dose of 4 mg per day).
Patients with malabsorption syndrome, disease significantly affecting
gastrointestinal function, or major resection of the stomach or small bowel that
could affect absorption of the study drug.
Women who are pregnant or breastfeeding.
Site Locations (2)
||University of Chicago
Hedy Kindler, M.D.
||New York University Cancer Center
Harvey Pass, M.D.
NCT ID: NCT00685204
Date Last Changed: May 22, 2008
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