NCT00061464

Brief Summary

The purposes of this study are to determine:

  1. 1.The safety of pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs.
  2. 2.Whether pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer.
  3. 3.Whether pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long.
  4. 4.To see if patients feel better while taking pemetrexed plus Gemcitabine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2003

Typical duration for phase_2

Geographic Reach
1 country

4 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

Study Start

First participant enrolled

February 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 29, 2003

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

January 26, 2007

Status Verified

January 1, 2007

First QC Date

May 28, 2003

Last Update Submit

January 24, 2007

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

  • To determine the tumor response rate for pemetrexed plus gemcitabine in patients with locally advanced or metastatic (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC).

Secondary Outcomes (8)

  • To measure time-to-event efficacy variables including:

  • time to objective tumor response for responding patients

  • duration of response for responding patients

  • time to treatment failure

  • time to progressive disease

  • +3 more secondary outcomes

Interventions

pemetrexedDRUG
gemcitabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy
  • Have received no prior chemotherapy for Non-Small Cell Lung Cancer
  • Have at least one measurable lesion
  • Have an adequate performance status
  • Sign an informed consent

You may not qualify if:

  • A female who is pregnant or breastfeeding
  • Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating pemetrexed
  • Treatment with radiation therapy within the last 1-2 weeks
  • Brain metastasis that is uncontrolled
  • Active infection or other serious condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Miami, Florida, United States

Location

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

Chicago, Illinois, United States

Location

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

Shreveport, Louisiana, United States

Location

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

Columbia, South Carolina, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

PemetrexedGemcitabine

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, DicarboxylicDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

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
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 28, 2003

First Posted

May 29, 2003

Study Start

February 1, 2003

Study Completion

February 1, 2006

Last Updated

January 26, 2007

Record last verified: 2007-01

Locations

US(4)