Pemetrexed Plus Cisplatin Neoadjuvant Therapy Followed By Surgery and Radiation in Mesothelioma - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00192010

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.

Condition	Intervention	Phase
Mesothelioma	Drug: pemetrexed Drug: cisplatin	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Mesothelioma Radiation Therapy Surgery

Drug Information available for: Cisplatin Pemetrexed Pemetrexed disodium

U.S. FDA Resources

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

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

Contacts and Locations

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

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.
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.
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.
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.
Rome, Italy, 00128

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	8848, H3E-IT-S079
Study First Received:	September 12, 2005
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00192010 History of Changes
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Antimetabolites
Folic Acid
Pemetrexed
Radiation-Sensitizing Agents
Cisplatin
Folate

Mesothelioma
Folinic Acid
Folic Acid Antagonists
Adenoma
Vitamin B9
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists

Pharmacologic Actions
Pemetrexed
Neoplasms
Cisplatin
Radiation-Sensitizing Agents
Therapeutic Uses
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009