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

This study has been completed.

First Received: April 18, 2006 Last Updated: March 26, 2009 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Mesothelioma

Drug Information available for: Pemetrexed Pemetrexed disodium

U.S. FDA Resources

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 ]

Enrollment:	31
Study Start Date:	December 2006
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (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

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.
Kobenhavn, Denmark, 2100
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.
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.
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

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:	10426, H3E-MC-JMHX
Study First Received:	April 18, 2006
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00316225 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Thoracic Neoplasms
Folate
Folinic Acid
Folic Acid Antagonists
Vitamin B9
Carcinoma
Pemetrexed
Folic Acid

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Mesothelioma
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Adenoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Thoracic Neoplasms
Respiratory Tract Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Mesothelial
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Carcinoma

Pemetrexed
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Mesothelioma
Carcinoma, Non-Small-Cell Lung
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009