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Completed

NCT Number: NCT00087698

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

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.

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Key information

Conditions

Pleural Neoplasms Neoplasms Neoplasms by Site Pleural Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary 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, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients will be clinically staged using AJCC/UICC TNM staging criteria. Eligible stages:
  • Patients must be M0
  • 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
  • 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  • Have previously completed or withdrawn from this study or any other study investigating pemetrexed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

Treatment and study plan

Pemetrexed

Drug

500 mg/m2, intravenous (IV), every 21 days x 4 cycles

Other names: LY231514, Alimta

Cisplatin

Drug

75 mg/m2, intravenous (IV), every 21 days x 4 cycles

Primary outcomes

  1. Pathological Complete Response

    Time frame: 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 outcomes

  1. The 1 and 2 Year Disease-Free Survival Rate (Percentage)

    Time frame: 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.

  2. Overall Tumor Response

    Time frame: 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.

  3. Time to Treatment Failure

    Time frame: 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.

  4. Time to Progressive Disease

    Time frame: 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.

  5. Overall Survival Time

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jul 16, 2004
Registry last updated
May 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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