Brief Summary

In previous phase 2 studies, pemetrexed has shown antitumor activity in advanced non-small cell lung cancer as a single agent as well as in combination with cisplatin. Since the introduction of vitamin supplementation, pemetrexed has shown good tolerance and high safety. Vitamin supplementation has opened the opportunity to offer patients higher pemetrexed dosing, as has been demonstrated by a recent Phase 1 study. The higher dose with supplementation may increase pemetrexed's efficacy without unduly compromising safety. The present Phase 2 study will use pemetrexed dosing that is tailored to individual patient tolerance, and is an effort to determine the efficacy and safety of this approach in patients with advanced NSCLC who had prior chemotherapy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

186

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Sep 2003

Geographic Reach

8 countries

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

Study Start

First participant enrolled

September 1, 2003

Completed

2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed

7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed

12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed

Last Updated

January 26, 2007

Status Verified

January 1, 2007

First QC Date

September 12, 2005

Last Update Submit

January 24, 2007

Conditions

Carcinoma, Non-Small Cell Lung

Outcome Measures

Primary Outcomes (1)

Response rate according to RECIST criteria

Secondary Outcomes (6)

To assess the following time to event efficacy variables:
o Duration of overall response for responding patients
o Time to progressive disease
o Time to treatment failure
o Survival
+1 more secondary outcomes

Interventions

pemetrexedDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

diagnosis of NSCLC
Locally advanced or metastatic disease (Stage IIIB or IV).
Patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
Disease status must be that of measurable disease as defined by RECIST criteria
Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale; and adequate organ function.

You may not qualify if:

Known or suspected brain metastasis, or Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
Concurrent administration of any other tumor therapy.
History of significant neurological or mental disorder, including seizures or dementia; or any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study
Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed.
Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (20)

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.

Wollongong, New South Wales, 2500, Australia

Location

Chermside, Queensland, 4032, Australia

Location

Ashford, South Australia, 5035, Australia

Location

Fitzroy, Victoria, 3065, Australia

Location

Hong Kong, China

Location

Alexandria, Egypt

Location

Cairo, 11796, Egypt

Location

Hyderabad, Andhra Pradesh, 500004, India

Location

Ludhiana, Punjab, 141001, India

Location

Chandigarh, 160012, India

Location

Chennai, 600035, India

Location

Delhi, 110085, India

Location

Oradea, Bihor County, 3700, Romania

Location

Craiova, Dolj, 1100, Romania

Location

Bucharest, 72435, Romania

Location

Iași, 6600, Romania

Location

Goyang-si, Gyeonggi-do, 411764, South Korea

Location

Seoul, South Korea

Location

Taipei, Taiwan

Location

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

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
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

September 1, 2003

Study Completion

October 1, 2005

Last Updated

January 26, 2007

Record last verified: 2007-01

Locations

IN(5)KR(2)TW(1)EG(2)AU(4)RO(4)TU(1)CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (20)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations