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A Multicenter Phase II Trial of Neo-Adjuvant Pemetrexed (Alimta) Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma


Phase 2
18 Years
N/A
Not Enrolling
Both
Pleural Neoplasms

Thank you

Trial Information

A Multicenter Phase II Trial of Neo-Adjuvant Pemetrexed (Alimta) Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma


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- Have previously completed or withdrawn from this study or any other study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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological Complete Response

Outcome Time Frame:

Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks)

Safety Issue:

No

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 Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

7216

NCT ID:

NCT00087698

Start Date:

September 2003

Completion Date:

February 2008

Related Keywords:

  • Pleural Neoplasms
  • Neoplasms
  • Mesothelioma
  • Pleural Neoplasms

Name

Location

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  
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  
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  
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  
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  
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  
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