Pemetrexed Disodium in Treating Patients With Stage IV Non-small Cell Lung Cancer and ECOG Performance Status 3
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|ClinicalTrials.gov Identifier: NCT02426658|
Recruitment Status : Active, not recruiting
First Posted : April 27, 2015
Results First Posted : March 18, 2020
Last Update Posted : November 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stage IV Non-Small Cell Lung Cancer||Other: Laboratory Biomarker Analysis Drug: Pemetrexed Disodium Other: Quality-of-Life Assessment||Phase 2|
I. To evaluate the effect of single agent pemetrexed (pemetrexed disodium) on tumor progression in ECOG performance status 3 patients with stage IV non-squamous histology non-small cell lung cancer in a single arm pilot study.
II. To evaluate the effect of single agent pemetrexed on quality of life in ECOG performance status 3 patients with stage IV non-squamous histology non-small cell lung cancer in a single arm pilot study.
I. To evaluate toxicity associated with single agent pemetrexed on tumor progression in ECOG performance status 3 patients with stage IV non-squamous histology non-small cell lung cancer in a single arm pilot study.
Patients receive pemetrexed disodium intravenously (IV) over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 30 days and then every 6 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Evaluating Pemetrexed in ECOG Performance Status 3 Patients With Stage IV Non-squamous Non-small Cell Lung Cancer|
|Actual Study Start Date :||May 2015|
|Actual Primary Completion Date :||June 7, 2018|
|Estimated Study Completion Date :||February 2021|
Experimental: Treatment (pemetrexed disodium)
Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality-of-Life Assessment and Laboratory Biomarker Analysis.
Other: Laboratory Biomarker Analysis
Drug: Pemetrexed Disodium
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
- Change in Quality of Life (QOL), Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and QLQ-Lung Cancer 13-item (LC13) [ Time Frame: Baseline to 12 weeks ]Quality of life will be assessed at each treatment time (i.e. every three weeks). A longitudinal mixed models analysis will be used to look at QOL over the time course. A paired t-test will also be calculated to see if the average change is more than 0 (worsening) versus a two-sided alternative that the difference is 0 or better. Score range from 0-100 (1 = not at all, 2 = a little, 3 = quite a bit, or 4 = very much). The higher the score, the greater the change in the quality of life for the worse.
- Time to Tumor Progression [ Time Frame: The duration of time from the start of treatment to the time of progression, death, or date of last contact, assessed up to 2 years ]It will be determined whether each patient has a progression (or dies) before or after 12 weeks. A 95% exact (Clopper Pearson) confidence interval will then be around the proportion with PFS greater than or equal to 12 weeks. If this confidence interval includes 50% then that would provide evidence that the therapy is potentially promising. If the upper bound of the confidence interval does not include 50% then this would indicate that the treatment may not be promising for patients. In addition, a Kaplan Meier survival curve will be constructed to describe the time to progression data.
- Incidence of Hematologic Toxicity, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: Up to 30 days ]The number and type of toxicities observed during this protocol will be estimated, focusing on unexpected grade 3 or higher toxicities. No formal statistical tests will be done on these estimates.
- Overall Survival [ Time Frame: The duration of time from the start of treatment to date of death or date of last contact, assessed up to 2 years ]Examined by estimating a Kaplan-Meier survival curve using all patients enrolled.
- Response Rate [ Time Frame: Up to 2 years ]Response rate will be estimated every 6 weeks for patients, and these estimates will be presented with confidence intervals.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426658
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Stefan Grant||Wake Forest University Health Sciences|