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ALIMTA(Pemetrexed)/Cisplatin and ALIMTA(Pemetrexed)/Carboplatin in Extensive Stage Small Cell Lung Cancer.

Primary Purpose

Lung Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ALIMTA
carboplatin
cisplatin
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Have a diagnosis of extensive stage small cell lung cancer and can be treated with chemotherapy. Have received no prior chemotherapy for your disease. Have at least one measurable lesion. have an adequate performance status. Sign an informed consent form. Exclusion Criteria: Have previously received chemotherapy for your lung cancer. Have been treated with a investigational drug within the last 30 days. Have previously completed or withdrawn from this study or any other study investigating ALIMTA. Have received radiation therapy within the last 1-2 weeks. Have brain metastasis that is uncontrolled. Have active infection or other serious condition.

Sites / Locations

  • For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
  • For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 10, 2003
Last Updated
July 18, 2006
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00051506
Brief Title
ALIMTA(Pemetrexed)/Cisplatin and ALIMTA(Pemetrexed)/Carboplatin in Extensive Stage Small Cell Lung Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects (good and bad) of ALIMTA plus Carboplatin or ALIMTA plus Cisplatin on you and your small cell lung cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ALIMTA
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of extensive stage small cell lung cancer and can be treated with chemotherapy. Have received no prior chemotherapy for your disease. Have at least one measurable lesion. have an adequate performance status. Sign an informed consent form. Exclusion Criteria: Have previously received chemotherapy for your lung cancer. Have been treated with a investigational drug within the last 30 days. Have previously completed or withdrawn from this study or any other study investigating ALIMTA. Have received radiation therapy within the last 1-2 weeks. Have brain metastasis that is uncontrolled. Have active infection or other serious condition.
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
City
Springdale
State/Province
Arkansas
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
City
Los Angeles
State/Province
California
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
City
Miami
State/Province
Florida
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
City
Latham
State/Province
New York
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
City
Burlington
State/Province
North Carolina
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
City
Charleston
State/Province
South Carolina
Country
United States

12. IPD Sharing Statement

Learn more about this trial

ALIMTA(Pemetrexed)/Cisplatin and ALIMTA(Pemetrexed)/Carboplatin in Extensive Stage Small Cell Lung Cancer.

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