This study aims to determine how successful the chemotherapy regimen of Pemetrexed plus cisplatin before surgery is at killing all the tumor so that none is left at the time of surgery. Following surgery, all eligible patients will receive radiation to the chest. How patients respond, whether the cancer returns and if so, where, will also be monitored.

Condition	Intervention	Phase
Pleural Neoplasms	Drug: Pemetrexed  Drug: Cisplatin	Phase II

Further study details as provided by Eli Lilly and Company:

Primary Outcomes: Pathological response in patients treated with preoperative chemotherapy, radiation and subsequent surgery.
Secondary Outcomes: To determine the 1 and 2 year disease-free survival, and median survival.; To determine clinical response rate measured by radiological assessment.; To characterize the quantitative and qualitative toxicities of chemotherapy, surgery and radiation in this patient population.; To determine the pattern of relapse (local versus metastatic).; To measure time-to-event efficacy variables including:; time to objective tumor response for responding patients; time to treatment failure; time to progressive disease; overall survival
Expected Total Enrollment:  77

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients will be clinically staged using AJCC/UICC TNM staging criteria. Eligible stages:

  1. Patients must be M0
  2. Patients with T1, T2, and T3 disease (without cardiac involvement) are eligible (T status can be established clinically and radiologically or at exploratory thoracotomy without surgical resection
  3. Patients with N0, N1,or N2 disease are eligible
• Performance status of 0 to 1 on the ECOG performance status schedule.
• No prior systemic chemotherapy and no prior intracavitary cytotoxic drugs or immunomodulators, unless given for the purpose of chemical pleurodesis
• No previous radiation therapy
• Estimated life expectancy of at least 12 weeks

Exclusion Criteria:

Patients will be excluded if they meet ANY of the following 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
• Have previously completed or withdrawn from this study or any other study investigating pemetrexed
• Pregnancy or breast-feeding
• Serious concomitant systemic disorders (i.e. active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
• Second active primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous carcinoma of the skin, low grade (Gleason score less than or equal to 6), localized adenocarcinoma of the prostate or other malignancy treated at least 2 years previously with no evidence of recurrence

Please refer to this study by ClinicalTrials.gov identifier  NCT00087698

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or      1-317-615-4559 

California
      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., San Francisco,  California,  United States; Recruiting
Illinois
      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., Chicago,  Illinois,  United States; Recruiting
Maryland
      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., Baltimore,  Maryland,  United States; No longer recruiting
Massachusetts
      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., Boston,  Massachusetts,  United States; Recruiting
Michigan
      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., Detroit,  Michigan,  United States; Recruiting
New York
      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., New York,  New York,  United States; Recruiting
Pennsylvania
      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., Philadelphia,  Pennsylvania,  United States; Recruiting
Texas
      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., Houston,  Texas,  United States; No longer recruiting

Study chairs or principal investigators

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 Director,  Eli Lilly and Company   

Study ID Numbers:  7216
Last Updated:  April 19, 2006
Record first received:  July 12, 2004
ClinicalTrials.gov Identifier:  NCT00087698
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-05-18