A Comparison of Two Doses of Pemetrexed in Patients Who Have Lung Cancer - Full Text View

Purpose

The purposes of this study are to determine:

the safety of pemetrexed and any side effects that might be associated with it
how much pemetrexed should be given to patients.

It is possible that information collected during this study will be analyzed by the Sponsor in the future to evaluate pemetrexed for other possible uses or for other medical or scientific purposes other than those currently proposed.

Although pemetrexed has been shown to be effective in some patients with non-small-cell lung cancer, pemetrexed might not have beneficial effects for all patients.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: pemetrexed	Phase III

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized Phase 3 Study of Two Doses of Alimta in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed a Prior Platinum-Containing Chemotherapy

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Progression free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Tumor response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Enrollment:	589
Study Start Date:	December 2003
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: pemetrexed A: 500 mg/m2, IV, q 21 days until disease progression B: 900 mg/m2, IV, q 21 days until disease progression
B: Experimental	Drug: pemetrexed A: 500 mg/m2, IV, q 21 days until disease progression B: 900 mg/m2, IV, q 21 days until disease progression

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 (NSCLC) that is not amenable to curative therapy.
Patients must have been previously treated with one platinum-containing chemotherapy regimen for locally advanced or metastatic disease. Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional chemotherapy regimen upon recurrence.
No more than two prior systemic anti-cancer therapies will be allowed.
Prior radiation therapy is allowed to less than 25% of the bone marrow. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment.

Exclusion Criteria:

Pregnancy.
Breast-feeding.
Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
Inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a 5-day period.
Inability or unwillingness to take folic acid or vitamin B12 supplementation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078260

Locations


Turkey
	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.
	Ankara, Turkey
	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.
	Gaziantep, Turkey

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:	8433, H3E-MC-JMGX
First Received:	February 20, 2004
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00078260
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

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Antimetabolites

Respiratory Tract Neoplasms

Neoplasms

Antimetabolites, Antineoplastic

Neoplasms by Site

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Folic Acid Antagonists

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00078260