Phase II Trial of Neoadjuvant ALIMTA Plus Cisplatin Followed by Surgery and Radiation in the Treatment of Pleural Mesothelioma
18 Years
N/A
Both
Mesothelioma
Trial Information
Phase II Trial of Neoadjuvant ALIMTA Plus Cisplatin Followed by Surgery and Radiation in the Treatment of Pleural Mesothelioma
Inclusion Criteria
Inclusion Criteria
- Histological proven diagnosis of stages I to III mesothelioma of the pleura.
- Adequate organ function including the following: adequate bone marrow reserve,
hepatic, renal, pulmonary and cardiac functions.
- No prior systemic chemotherapy
- No previous surgical resection of mesothelioma, with the exception of previous
chemical pleurodesis.
- No previous radiation therapy.
Exclusion Criteria
- Have received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication at the time of study entry.
- Serious concomitant systemic disorders
- Second active primary malignancy
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a
5-day period
- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or
dexamethasone
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Event-free Survival (EFS)
Outcome Description:
A participant was defined event-free if they did not show a progressive disease (PD), did not die and did not discontinue the treatment early. Participants without assessment at 1-year (due to whatever reason) were considered as Not-Event-Free.
Outcome Time Frame:
date of first dose of study drug to first observation of disease progression, death from any cause, discontinuation of treatment (up to 43 months)
Safety Issue:
Yes
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Chair
Investigator Affiliation:
Eli Lilly and Company
Authority:
Italy: Ministry of Health
Study ID:
8848
NCT ID:
NCT00192010
Start Date:
June 2005
Completion Date:
February 2010
Related Keywords:
- Mesothelioma
- Mesothelioma
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