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

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

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Have previously completed or withdrawn from this study or any other study investigating pemetrexed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

Arm && Interventions

Group	Intervention	Description
A	cisplatin	chemotherapy, surgery then chest radiation x 54 gray (Gy)
A	pemetrexed	chemotherapy, surgery then chest radiation x 54 gray (Gy)

Primary Outcome Measures

Name	Time	Method
Pathological Complete Response	Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks)	Number of participants with results of pathological review that indicated a complete response. Pathological complete response should be evaluated at the time of surgery (Extrapleural Pneumonectomy \[EPP\]). Resected tissue or pleural fluid should be sent for pathological and histological evaluation.

Secondary Outcome Measures

Name	Time	Method
The 1 and 2 Year Disease-Free Survival Rate (Percentage)	1 year and 2 years	Kaplan-Meier estimates of the percentage of participants still alive at 1-year and 2-years, based upon the total number of participants who had surgery.
Overall Tumor Response	baseline to measured progressive disease	The frequency of best overall tumor response summarized by response category. The best (unconfirmed) response recorded from the start of chemotherapy treatment until disease progression/recurrence, start of any further anti-tumor therapy, or time of surgery whichever comes first.
Time to Treatment Failure	baseline to stopping treatment	Time to relapse (treatment failure) is measured in months and calculated as (Date of first surgery - Date of first relapse after surgery + 1)/(365.25/12). Time to relapse will be censored at the date of the last visit or start date of further anti-tumor therapy or intervention, whichever comes first.
Time to Progressive Disease	baseline to measured progressive disease	Number of months between the first dose date and the date of first disease progression or death as a result of any cause, whichever comes first.
Overall Survival Time	baseline to date of death from any cause	Number of months between the first dose date and the date of death as a result of any cause. Overall survival time calculated as (Date of death - First dose date + 1)/(365.25/12).

Locations (1): 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.
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Houston, Texas, United States