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

Lilly

Status and phase

Completed

Phase 2

Conditions

Pleural Neoplasms

Treatments

Drug: pemetrexed

Drug: cisplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00087698

H3E-US-JMGA

7216

Details and patient eligibility

About

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.

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No 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Have previously completed or withdrawn from this study or any other study investigating pemetrexed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