Clinical Trial Phase: Phase 2 Start Date: June 2005
Overall Status: Recruiting
Estimated Enrollment: 53

Rationale

Condition Keyword(s): Mesothelioma

Interventions:
Drug: pemetrexed
Drug: cisplatin

Phase II trial of Neoadjuvant Chemotherapy with Pemetrexed plus Cisplatin followed by Surgery and Radiotherapy in patients with Malignant Pleural Mesothelioma stage I-III.

The event-free survival is the primary endpoint for this study. This is a multicenter study and 53 Patients will be enrolled by June 2008.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Outcome Measures for this Clinical Trial

Primary: Event-free survival baseline to objective progression, start of new therapy or death from any cause

Secondary

• 1- and 2- year disease free survival baseline to post surgery
  
• To determine complete pathological response rate surgical complete response post chemotherapy, surgery and radiation
  
• Pharmacology toxicity every cycle
  
• Time to objective tumor response baseline to response of tumor
  
• Time to progressive disease baseline to measured progressive disease
  
• Overall survival baseline to date of death from any cause

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

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: Eli Lilly and Company
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Overall Clinical Trial Officials and Contacts
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) Study Chair Eli Lilly and Company

Overall Contact: They may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Additional Information

Information obtained from ClinicalTrials.gov on April 15, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00192010

Study ID Number: 8848

ClinicalTrials.gov Identifier: NCT00192010

Labels: ClinicalTrial