Back to resultsA Study of Pemetrexed in Small Cell Lung Cancer, Which Has Returned
Primary Purpose
Carcinoma, Small Cell
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Small Cell
Eligibility Criteria
Inclusion Criteria: Diagnosis of small cell lung cancer One prior treatment with chemotherapy or immunotherapy with greater than 3 weeks since the prior treatment At least 18 years of age Estimated life expectancy of at least 12 weeks Ambulatory and capable of self-care(eg, up and about greater than 50% of waking hours) Exclusion Criteria: Have received treatment within the last 30 days with a drug that has not received FDA approval for any indication Less than 2 weeks from radiation therapy Other serious illness that would compromise the safety of the patient Most second primary malignancies treated less than 5 years previously
Sites / Locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Outcomes
Primary Outcome Measures
To assess the antitumor activity for patients with both sensitive and refractory small cell lung cancer patients as measured by tumor response rate. To characterize the toxicities of pemetrexed in this patient population
Secondary Outcome Measures
To better understand any side effects of pemetrexed
Full Information
NCT ID
NCT00191750
First Posted
September 12, 2005
Last Updated
January 24, 2007
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00191750
Brief Title
A Study of Pemetrexed in Small Cell Lung Cancer, Which Has Returned
Official Title
Phase II Trial of ALIMTA in Relapsed Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
The purposes of this study are to determine 1) the safety of pemetrexed and any side effects that might be associated with it 2) whether pemetrexed can help patients with small cell lung cancer live longer 3) whether pemetrexed can make tumors smaller or disappear and for how long and 4) to see if patients feel better while taking pemetrexed
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Small Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Primary Outcome Measure Information:
Title
To assess the antitumor activity for patients with both sensitive and refractory small cell lung cancer patients as measured by tumor response rate. To characterize the toxicities of pemetrexed in this patient population
Secondary Outcome Measure Information:
Title
To better understand any side effects of pemetrexed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of small cell lung cancer
One prior treatment with chemotherapy or immunotherapy with greater than 3 weeks since the prior treatment
At least 18 years of age
Estimated life expectancy of at least 12 weeks
Ambulatory and capable of self-care(eg, up and about greater than 50% of waking hours)
Exclusion Criteria:
Have received treatment within the last 30 days with a drug that has not received FDA approval for any indication
Less than 2 weeks from radiation therapy
Other serious illness that would compromise the safety of the patient
Most second primary malignancies treated less than 5 years previously
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), 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 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Dallas
State/Province
Texas
Country
United States
12. IPD Sharing Statement
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A Study of Pemetrexed in Small Cell Lung Cancer, Which Has Returned
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