Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT00071136

Last Updated: 2007-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2006-08-31

Brief Summary

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This is a Phase 2 study of pemetrexed and gemcitabine chemotherapy given once every 14 days to patients with advanced stage non-small cell lung cancer. This treatment is for patients that have not received any prior chemotherapy treatment for lung cancer. The primary goal is to find out if the tumor gets smaller or disappears with this treatment.

Detailed Description

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Conditions

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Lung Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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pemetrexed

Intervention Type DRUG

gemcitabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Have a diagnosis of advanced stage non-small cell lung cancer.
2. Are able to be active at home and/or work.
3. Have not received chemotherapy for this cancer disease.
4. Have good organ function (for example, most blood work is normal).
5. Have completed any prior radiation treatment at least 4 weeks ago.

Exclusion Criteria

1. Have been treated with an investigational/research drug within the last month.
2. Have cancer that has spread to the brain and is causing symptoms.
3. Have an active infection or other serious medical condition.
4. Have a second cancer in addition to non-small cell lung cancer.
5. Can not stop taking aspirin or other anti-inflammatory agents for 5-8 days.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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.

Fort Myers, Florida, United States

Site Status

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.

Marshfield, Minnesota, United States

Site Status

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.

Minneapolis, Minnesota, United States

Site Status

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.

Rochester, New York, United States

Site Status

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.

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H3E-US-JMGC

Identifier Type: -

Identifier Source: secondary_id

7221

Identifier Type: -

Identifier Source: org_study_id

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