Back to resultsAlimta, Carboplatin and Radiation Therapy for Non Small Cell Lung Cancer
Primary Purpose
Inoperable Non Small Cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Premetrexed (Alimta)
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Inoperable Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: Unresectable Stage II, IIIB or IV non small cell lung cancer. Evaluable disease on planning CT scan Zubrod 0-1 Weight loss equal to or less than 10% 3 months prior to diagnosis FEV1 greater than 1000cc Adequate hematologic, renal and hepatic functions Exclusion Criteria: Small cell cancer Stage I non small cell cancer Prior chemotherapy or thoracic or lower neck radiatio therapy
Sites / Locations
- Thomas Jefferson University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drug
Arm Description
Carboplatin and Pemetrexed
Outcomes
Primary Outcome Measures
Response and Progression Free Survival
Secondary Outcome Measures
Full Information
NCT ID
NCT00330044
First Posted
May 24, 2006
Last Updated
December 1, 2016
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00330044
Brief Title
Alimta, Carboplatin and Radiation Therapy for Non Small Cell Lung Cancer
Official Title
A Phase I Study of Premetrexed (Alimta) and Carboplatin and Radiation Therapy in Patients With Inoperable Non Small Cell Lung Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine the safety of Alimta when used with chemoradiation in inoperable non small cell lung cancer
Detailed Description
To determine the maximal tolerated dose (MTD) and toxicities of Pemetrexed (Alimta) when administered concurrently with carboplatin and thoracic radiation therapy.
To determine, qualitatively, the occurrence of local tumor responses identified with this regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inoperable Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug
Arm Type
Experimental
Arm Description
Carboplatin and Pemetrexed
Intervention Type
Drug
Intervention Name(s)
Premetrexed (Alimta)
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Primary Outcome Measure Information:
Title
Response and Progression Free Survival
Time Frame
Up to five years after study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unresectable Stage II, IIIB or IV non small cell lung cancer. Evaluable disease on planning CT scan Zubrod 0-1 Weight loss equal to or less than 10% 3 months prior to diagnosis FEV1 greater than 1000cc Adequate hematologic, renal and hepatic functions
Exclusion Criteria:
Small cell cancer Stage I non small cell cancer Prior chemotherapy or thoracic or lower neck radiatio therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Werner-Wasik, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital
Learn more about this trial
Alimta, Carboplatin and Radiation Therapy for Non Small Cell Lung Cancer
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