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

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.

Tracking Information
First Received DateJuly 12, 2004
Last Changed DateMay 1, 2009
Start DateSeptember 2003
Actual Primary Completion DateFebruary 2008
Primary Outcome Measures

Pathological Complete Response [Time Frame: Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks)]

Secondary Outcome Measures

The 1 and 2 Year Disease-Free Survival Rate (Percentage) [Time Frame: 1 year and 2 years]

Overall Tumor Response [Time Frame: baseline to measured progressive disease]

Time to Treatment Failure [Time Frame: baseline to stopping treatment]

Time to Progressive Disease [Time Frame: baseline to measured progressive disease]

Overall Survival Time [Time Frame: baseline to date of death from any cause]

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Pleural Neoplasms
Intervention
  • Drug: pemetrexed
  • Drug: cisplatin
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment77
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility 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

Administrative Information
NCTIDNCT00087698
Responsible PartyChief Medical Officer, Eli Lilly
SponsorEli Lilly and Company
Verification DateMay 2009
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