Mesothelioma Related Clinical Trials:
Phase II Trial of Neoadjuvant ALIMTA Plus Cisplatin Followed by Surgery and Radiation in the Treatment of Pleural Mesothelioma

Article Tools:

In Page Navigation: - General Info - Purpose - Eligibility - Contacts & Locations - Additional Information

   

Status: Recruiting
Sponsors and Collaborators: Eli Lilly and Company
Information provided by: Eli Lilly and Company
Government Identifier: NCT00192010

Condition: Mesothelioma
Intervention: Drug: pemetrexed; Drug: cisplatin

    - Return To Top

Purpose:


Phase II trial of Neoadjuvant Chemotherapy with Pemetrexed plus Cisplatin followed by Surgery and Radiotherapy in patients with Malignant Pleural Mesothelioma stage I-III.

The event-free survival is the primary endpoint for this study. This is a multicenter study and 53 Patients will be enrolled by June 2008.

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase II Trial of Neoadjuvant ALIMTA Plus Cisplatin Followed by Surgery and Radiation in the Treatment of Pleural Mesothelioma

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: baseline to objective progression, start of new therapy or death from any cause ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1- and 2- year disease free survival [ Time Frame: baseline to post surgery ] [ Designated as safety issue: No ]
  • To determine complete pathological response rate [ Time Frame: surgical complete response post chemotherapy, surgery and radiation ] [ Designated as safety issue: No ]
  • Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Time to objective tumor response [ Time Frame: baseline to response of tumor ] [ Designated as safety issue: No ]
  • Time to progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   53
Study Start Date:   June 2005
Estimated Study Completion Date:   March 2009
Estimated Primary Completion Date:   March 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Experimental
Chemotherapy, surgery, extrapleural pneumonectomy then radiation x 54 Gy
Drug: pemetrexed
500 mg/m2, IV, q 21 days x 3 cycles
Drug: cisplatin
75 mg/m2, IV, q 21 days x 3 cycles

    - Return To Top

Eligibility:

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

  • Histological proven diagnosis of stages I to III mesothelioma of the pleura.
  • Adequate organ function including the following: adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.
  • No prior systemic chemotherapy
  • No previous surgical resection of mesothelioma, with the exception of previous chemical pleurodesis.
  • No previous radiation therapy.

Exclusion 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.
  • Serious concomitant systemic disorders
  • Second active primary malignancy
  • Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period
  • Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone

    - Return To Top

Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192010

Contacts
Contact: They may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or     1-317-615-4559    
Locations
Italy
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.     Active, not recruiting
      Mestre/Venezia, Italy, 30170
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.     Active, not recruiting
      Milano, Italy, 20141
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.     Active, not recruiting
      Padova, Italy, 35100
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.     Active, not recruiting
      Rome, Italy, 00128
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.     Recruiting
      Napoli, Italy, 80131
      Contact: Eli Lilly            

Sponsors and Collaborators
Eli Lilly and Company

Investigators
Study Chair:     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    

    - Return To Top

Additional Information:

Responsible Party:   Eli Lilly ( Chief Medical Officer )
Study ID Numbers:   8848, H3E-IT-S079
First Received:   September 12, 2005
Last Updated:   February 11, 2008
ClinicalTrials.gov Identifier:   NCT00192010
Health Authority:   Italy: Ministry of Health

Study placed in the following topic categories:
Folic Acid
Pemetrexed
Cisplatin
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Mesothelioma
Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses

    - Return To Top

Free case consultation

If you or a loved one has been diagnosed with mesothelioma or another asbestos-related disease, contact us using the form below to speak with a mesothelioma consultant, free of charge.