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Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Phase II Trial of Neo-Adjuvant Pemetrexed Plus Cisplatin Followed by Surgery and Radiation for Pleural Mesothelioma

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

NCT00087698•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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•Have previously completed or withdrawn from this study or any other study investigating pemetrexed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

Locations (7)

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

Chicago, Illinois, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

New York, New York, United States

Houston, Texas, United States

Key Dates

Start Date

September 1, 2003

Primary Completion Date

February 1, 2008

Completion Date

February 1, 2008

Last Updated

May 12, 2009

Enrollment

ACTUAL participants

Conditions

Pleural Neoplasms

Interventions

pemetrexed

DRUG

cisplatin

DRUG

OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion.

NCT06421610

Malignant Pleural EffusionPleural Neoplasms+5 more

View study

COMPLETED

Thoracic OncoGeriatric Assessment (TOGA) Trials

NCT00591981

Thoracic NeoplasmsLung Neoplasms+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 12, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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