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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00087698
First received: July 12, 2004
Last updated: May 1, 2009
Last verified: May 2009

July 12, 2004
May 1, 2009
September 2003
February 2008   (final data collection date for primary outcome measure)
Pathological Complete Response [ Time Frame: Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks) ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00087698 on ClinicalTrials.gov Archive Site
  • The 1 and 2 Year Disease-Free Survival Rate (Percentage) [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
  • Overall Tumor Response [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Time to Treatment Failure [ Time Frame: baseline to stopping treatment ] [ Designated as safety issue: Yes ]
  • Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Overall Survival Time [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pleural Neoplasms
  • Drug: pemetrexed
    500 mg/m2, intravenous (IV), every 21 days x 4 cycles
    Other Names:
    • LY231514
    • Alimta
  • Drug: cisplatin
    75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Experimental: A
chemotherapy, surgery then chest radiation x 54 gray (Gy)
Interventions:
  • Drug: pemetrexed
  • Drug: cisplatin
Federico R, Adolfo F, Giuseppe M, Lorenzo S, Martino DT, Anna C, Adriano P, Gino C, Francesca R, Matteo C, Gbenga K, Paolo M, Francesco F. Phase II trial of neoadjuvant pemetrexed plus cisplatin followed by surgery and radiation in the treatment of pleural mesothelioma. BMC Cancer. 2013 Jan 16;13:22. doi: 10.1186/1471-2407-13-22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00087698
7216, H3E-US-JMGA
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP