Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen - Full Text View

Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen

This study is currently recruiting participants.
Verified by Eli Lilly and Company, November 2008

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00316225

Purpose

This study will test the effects of pemetrexed on mesothelioma and lung cancer patients with fluid around their lungs or abdomen.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer Mesothelioma Lung Neoplasms	Drug: pemetrexed	Phase II

MedlinePlus related topics:

Cancer Lung Cancer Mesothelioma

Drug Information available for:

Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	A Phase 2 Study of ALIMTA in Solid Tumor Patients With Stable Third-Space Fluid

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Pharmacology toxicity [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse events [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
Pharmacokinetics [ Time Frame: cycle 1, cycle 2 ] [ Designated as safety issue: Yes ]
Pemetrexed dosing recommendations [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: pemetrexed 500 mg/m2, IV, q 21 days x 6 cycles

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer or mesothelioma
Presence of third-space fluid (fluid around the lungs or abdomen).
Measurable lesions are not required for enrollment in this study.
Prior anticancer treatment (except radiation) must be completed at least 3 weeks prior to study enrollment, and the patient must have recovered from the sharp toxic effects the anticancer treatment.
Estimated life expectancy of at least 8 weeks.

Exclusion Criteria:

Have received treatment within the last 30 days with a drug that was not a marketed product
Active infection that, in the opinion of the investigator, would not allow the patient to tolerate therapy.
Pregnancy.
Breast-feeding.
Significant weight loss (that is, greater than or equal to 10% of body weight) over the 6 weeks before study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316225

Contacts


Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or	1-317-615-4559

Locations


Denmark
	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
	Kobenhavn, Denmark, 2100
	Contact: Eli Lilly

Germany
	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
	Hannover, Germany, 30625

Spain
	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
	Madrid, Spain, 28041

Sponsors and Collaborators

Eli Lilly and Company

Investigators


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

More Information

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

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10426, H3E-MC-JMHX
First Received:	April 18, 2006
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00316225
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Folic Acid

Pemetrexed

Thoracic Neoplasms

Non-small cell lung cancer

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Mesothelioma

Adenoma

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Antimetabolites

Respiratory Tract Neoplasms

Neoplasms by Histologic Type

Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action

Neoplasms, Mesothelial

Antineoplastic Agents

Enzyme Inhibitors

Folic Acid Antagonists

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2008