Trial Outcomes & Findings for Pemetrexed Disodium in Treating Patients With Stage IV Non-small Cell Lung Cancer and ECOG Performance Status 3 (NCT NCT02426658)
NCT ID: NCT02426658
Last Updated: 2023-10-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2023-10-12
Participant Flow
Participant milestones
| Measure |
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.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
Quality-of-Life Assessment: QOL studies
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
Quality-of-Life Assessment: QOL studies
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Patient expired before treatment
|
2
|
Baseline Characteristics
Pemetrexed Disodium in Treating Patients With Stage IV Non-small Cell Lung Cancer and ECOG Performance Status 3
Baseline characteristics by cohort
| Measure |
Treatment (Pemetrexed Disodium)
n=13 Participants
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.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
Quality-of-Life Assessment: QOL studies
|
|---|---|
|
Age, Continuous
|
70.6 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksQuality 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.
Outcome measures
| Measure |
Treatment (Pemetrexed Disodium)
n=13 Participants
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.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
Quality-of-Life Assessment: QOL studies
|
|---|---|
|
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)
Baseline
|
51.2821 score on a scale
Standard Error 6.6951
|
|
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)
12 weeks
|
58.3333 score on a scale
Standard Error 17.0693
|
PRIMARY outcome
Timeframe: The duration of time from the start of treatment to the time of progression, death, or date of last contact, assessed up to 2 yearsIt 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.
Outcome measures
| Measure |
Treatment (Pemetrexed Disodium)
n=12 Participants
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.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
Quality-of-Life Assessment: QOL studies
|
|---|---|
|
Time to Tumor Progression
|
2.0 months
Interval 1.0 to 10.7
|
SECONDARY outcome
Timeframe: Up to 30 daysThe 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.
Outcome measures
| Measure |
Treatment (Pemetrexed Disodium)
n=13 Participants
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.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
Quality-of-Life Assessment: QOL studies
|
|---|---|
|
Incidence of Hematologic Toxicity, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Anemia
|
13 Participants
|
|
Incidence of Hematologic Toxicity, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
CD4 lymphocyte decreased
|
3 Participants
|
|
Incidence of Hematologic Toxicity, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Febrile neutropenia
|
1 Participants
|
|
Incidence of Hematologic Toxicity, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Leukocytosis
|
1 Participants
|
|
Incidence of Hematologic Toxicity, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Lymphocyte count decreased
|
9 Participants
|
|
Incidence of Hematologic Toxicity, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Neutrophil count decreased
|
11 Participants
|
|
Incidence of Hematologic Toxicity, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Platelet count decreased
|
10 Participants
|
|
Incidence of Hematologic Toxicity, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
White blood cell count decreased
|
10 Participants
|
SECONDARY outcome
Timeframe: The duration of time from the start of treatment to date of death or date of last contact, assessed up to 2 yearsExamined by estimating a Kaplan-Meier survival curve using all patients enrolled.
Outcome measures
| Measure |
Treatment (Pemetrexed Disodium)
n=13 Participants
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.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
Quality-of-Life Assessment: QOL studies
|
|---|---|
|
Overall Survival
|
2.4 months
Interval 1.0 to 10.7
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Four patients died prior to the 2nd cycle of treatment when this measure was evaulated.
Response rate will be estimated every 6 weeks for patients, and these estimates will be presented with confidence intervals.
Outcome measures
| Measure |
Treatment (Pemetrexed Disodium)
n=9 Participants
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.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
Quality-of-Life Assessment: QOL studies
|
|---|---|
|
Response Rate
Partial response
|
1 Participants
|
|
Response Rate
Stable disease
|
6 Participants
|
|
Response Rate
Progressive disease
|
2 Participants
|
Adverse Events
Treatment (Pemetrexed Disodium)
Serious events: 12 serious events
Other events: 12 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Treatment (Pemetrexed Disodium)
n=13 participants at risk
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.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
Quality-of-Life Assessment: QOL studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
15.4%
2/13 • Number of events 2 • 30 days after the last study is administered
|
|
General disorders
Death, NOS
|
30.8%
4/13 • Number of events 4 • 30 days after the last study is administered
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Investigations
Lymphocyte count decreased
|
15.4%
2/13 • Number of events 2 • 30 days after the last study is administered
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Infections and infestations
Sepsis
|
23.1%
3/13 • Number of events 3 • 30 days after the last study is administered
|
|
Vascular disorders
Thromboembolic event
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
Other adverse events
| Measure |
Treatment (Pemetrexed Disodium)
n=13 participants at risk
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.
Laboratory Biomarker Analysis: Correlative studies
Pemetrexed Disodium: Given IV
Quality-of-Life Assessment: QOL studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
2/13 • Number of events 2 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Acidosis
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Renal and urinary disorders
Acute kidney injury
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Investigations
Alkaline phosphatase increased
|
7.7%
1/13 • Number of events 2 • 30 days after the last study is administered
|
|
Blood and lymphatic system disorders
Anemia
|
76.9%
10/13 • Number of events 18 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Anorexia
|
15.4%
2/13 • Number of events 2 • 30 days after the last study is administered
|
|
Investigations
Aspartate aminotransferase increased
|
23.1%
3/13 • Number of events 3 • 30 days after the last study is administered
|
|
Investigations
CD4 lymphocytes decreased
|
23.1%
3/13 • Number of events 4 • 30 days after the last study is administered
|
|
Cardiac disorders
Cardiac disorders, other
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Cardiac disorders
Chest pain - cardiac
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
General disorders
Chills
|
15.4%
2/13 • Number of events 2 • 30 days after the last study is administered
|
|
Renal and urinary disorders
Chronic kidney disease
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Psychiatric disorders
Confusion
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.8%
4/13 • Number of events 6 • 30 days after the last study is administered
|
|
Investigations
Creatinine increased
|
15.4%
2/13 • Number of events 2 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
2/13 • Number of events 3 • 30 days after the last study is administered
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Number of events 2 • 30 days after the last study is administered
|
|
Nervous system disorders
Dysarthria
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
61.5%
8/13 • Number of events 12 • 30 days after the last study is administered
|
|
General disorders
Edema limbs
|
23.1%
3/13 • Number of events 4 • 30 days after the last study is administered
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
General disorders
Fatigue
|
38.5%
5/13 • Number of events 8 • 30 days after the last study is administered
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
General disorders
Fever
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
General disorders
Gait disturbance
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
General disorders
General disorders and administration site disorders, other
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
30.8%
4/13 • Number of events 6 • 30 days after the last study is administered
|
|
Renal and urinary disorders
Hematuria
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.7%
1/13 • Number of events 2 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
92.3%
12/13 • Number of events 26 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
69.2%
9/13 • Number of events 13 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
38.5%
5/13 • Number of events 6 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Hypokalemia
|
46.2%
6/13 • Number of events 6 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
23.1%
3/13 • Number of events 3 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Hyponatremia
|
69.2%
9/13 • Number of events 12 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.4%
2/13 • Number of events 2 • 30 days after the last study is administered
|
|
Vascular disorders
Hypotension
|
15.4%
2/13 • Number of events 2 • 30 days after the last study is administered
|
|
Investigations
Investigations, other
|
15.4%
2/13 • Number of events 2 • 30 days after the last study is administered
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
General disorders
Localized edema
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Infections and infestations
Lung infection
|
15.4%
2/13 • Number of events 2 • 30 days after the last study is administered
|
|
Investigations
Lymphocyte count decreased
|
53.8%
7/13 • Number of events 11 • 30 days after the last study is administered
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders, other
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Gastrointestinal disorders
Mucositis, oral
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Gastrointestinal disorders
Nausea
|
30.8%
4/13 • Number of events 7 • 30 days after the last study is administered
|
|
Investigations
Neutrophil count decreased
|
46.2%
6/13 • Number of events 6 • 30 days after the last study is administered
|
|
General disorders
Non-cardiac chest pain
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
General disorders
Pain
|
15.4%
2/13 • Number of events 2 • 30 days after the last study is administered
|
|
Investigations
Platelet count decreased
|
53.8%
7/13 • Number of events 9 • 30 days after the last study is administered
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
15.4%
2/13 • Number of events 2 • 30 days after the last study is administered
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Cardiac disorders
Sinus tachycardia
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders, other
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Gastrointestinal disorders
Stomach pain
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Nervous system disorders
Tremor
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Gastrointestinal disorders
Vomiting
|
46.2%
6/13 • Number of events 6 • 30 days after the last study is administered
|
|
Eye disorders
Watering eyes
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Investigations
Weight loss
|
7.7%
1/13 • Number of events 1 • 30 days after the last study is administered
|
|
Investigations
White blood cell decreased
|
61.5%
8/13 • Number of events 11 • 30 days after the last study is administered
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place