Phase II Study Alimta and Gemzar + Avastin as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV NSCLC
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ClinicalTrials.gov Identifier: NCT00517595 |
Recruitment Status
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Completed
First Posted
: August 17, 2007
Results First Posted
: March 8, 2012
Last Update Posted
: March 12, 2012
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Sponsor:
Accelerated Community Oncology Research Network
Collaborators:
Eli Lilly and Company
Genentech, Inc.
Information provided by (Responsible Party):
Accelerated Community Oncology Research Network
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Tracking Information | ||||
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First Submitted Date ICMJE | August 16, 2007 | |||
First Posted Date ICMJE | August 17, 2007 | |||
Results First Submitted Date | October 11, 2011 | |||
Results First Posted Date | March 8, 2012 | |||
Last Update Posted Date | March 12, 2012 | |||
Study Start Date ICMJE | August 2007 | |||
Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression Free Survival (PFS) [ Time Frame: PFS was measured from day 1 of treatment until time of progression (assessed every 8 weeks) or death, whichever came first, assessed up to 15 months. ] PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is defined per RECIST criteria v1.0 as a measurable increase in the smallest diameter of any target lesion, progression of existing non-target lesions, or the appearance of 1 or more new lesions. The median progression free survival is the parameter used to describe PFS.
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Original Primary Outcome Measures ICMJE |
The primary endpoint will be the percent of patients who are progression free (PFS) at 12 months after initiation of treatment. | |||
Change History | Complete list of historical versions of study NCT00517595 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Secondary endpoints will be overall response rate (RECIST), overall survival, and changes from baseline in PCM scores. Also, time to progression will be evaluated as it relates to the number of cycles prior to progression and duration. | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Phase II Study Alimta and Gemzar + Avastin as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV NSCLC | |||
Official Title ICMJE | A Phase II Study of Pemetrexed and Gemcitabine Plus Bevacizumab as First Line Chemotherapy for Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer | |||
Brief Summary | The primary objective is to determine the progression free survival with pemetrexed, and gemcitabine plus bevacizumab as first-line chemotherapy in elderly patients with Stage IIIB/IV non-small cell lung cancer (NSCLC). The secondary objectives are to determine the overall response rate; overall survival; chemotherapy induced toxicity profile of this combination; time to progression; and patient reported symptom burden. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-Small Cell Lung Cancer | |||
Intervention ICMJE | Drug: Pemetrexed and Gemcitabine plus Bevacizumab
Bevacizumab 10 mg/kg will be given intravenously according to weight. Pemetrexed 500 mg/m^2 and gemcitabine 1500 mg/m^2 will be given intravenously according to weight and height. All agents are administered every 2 weeks.
Other Names:
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Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
48 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | April 2011 | |||
Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 65 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00517595 | |||
Other Study ID Numbers ICMJE | ALJBNSCLC0602 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Accelerated Community Oncology Research Network | |||
Study Sponsor ICMJE | Accelerated Community Oncology Research Network | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Accelerated Community Oncology Research Network | |||
Verification Date | March 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |