Trial Outcomes & Findings for Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer (NCT NCT00193414)
NCT ID: NCT00193414
Last Updated: 2022-03-03
Results Overview
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
18 months
Results posted on
2022-03-03
Participant Flow
Participant milestones
| Measure |
Intervention
Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
|
|---|---|
|
Overall Study
STARTED
|
72
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
58
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Intervention
n=72 Participants
Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
43 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: All patients were assessed for response.
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
Outcome measures
| Measure |
Intervention
n=72 Participants
Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
|
|---|---|
|
Overall Response Rate
|
26 Percentage of participants
Interval 17.0 to 38.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All patients were assessed for PFS.
PFS was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death from any cause.
Outcome measures
| Measure |
Intervention
n=72 Participants
Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
|
|---|---|
|
Progression-free Survival (PFS)
|
6.2 Months
Interval 4.1 to 8.1
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All patients were assessed for OS.
OS was measured from the date of study entry until the date of death.
Outcome measures
| Measure |
Intervention
n=72 Participants
Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
|
|---|---|
|
Overall Survival (OS)
|
8.5 Months
Interval 6.7 to 11.5
|
Adverse Events
Intervention
Serious events: 39 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=72 participants at risk
Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
|
|---|---|
|
Nervous system disorders
Altered Mental Status
|
1.4%
1/72
|
|
Cardiac disorders
Cardiac General - Other (Congestive Heart Failure)
|
1.4%
1/72
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
1.4%
1/72
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.4%
1/72
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
4.2%
3/72
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/72
|
|
General disorders
Death not associated with CTCAE term - Disease Progression NOS
|
23.6%
17/72
|
|
Endocrine disorders
Pancreatic endocrine: glucose intolerance
|
1.4%
1/72
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
1/72
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.8%
2/72
|
|
General disorders
Fatigue
|
1.4%
1/72
|
|
Infections and infestations
Febrile Neutropenia
|
4.2%
3/72
|
|
General disorders
Fever
|
1.4%
1/72
|
|
Musculoskeletal and connective tissue disorders
Fracture (Limb)
|
1.4%
1/72
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.8%
2/72
|
|
Blood and lymphatic system disorders
Hemorrhage, GI
|
1.4%
1/72
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.4%
1/72
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.4%
1/72
|
|
General disorders
Hypoxemia
|
4.2%
3/72
|
|
Infections and infestations
Infection - Other (Cellulitis)
|
4.2%
3/72
|
|
Infections and infestations
Infection - Other (Pneumonia)
|
11.1%
8/72
|
|
Blood and lymphatic system disorders
Leukocytes
|
1.4%
1/72
|
|
Nervous system disorders
Neurology - Other (Spinal Cord Compression)
|
1.4%
1/72
|
|
Gastrointestinal disorders
Pain - Gastrointestinal
|
1.4%
1/72
|
|
General disorders
Pain - NOS
|
1.4%
1/72
|
|
Blood and lymphatic system disorders
Pancytopenia (NOS)
|
1.4%
1/72
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.8%
2/72
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Post obstructive lung process)
|
1.4%
1/72
|
|
Renal and urinary disorders
Renal Failure
|
1.4%
1/72
|
|
Nervous system disorders
Seizure
|
1.4%
1/72
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial Arrhythmia (NOS)
|
1.4%
1/72
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial Fibrillation
|
5.6%
4/72
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial Flutter
|
1.4%
1/72
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
8.3%
6/72
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Supraventricular tachycardia
|
1.4%
1/72
|
Other adverse events
| Measure |
Intervention
n=72 participants at risk
Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.2%
16/72
|
|
Gastrointestinal disorders
Anorexia
|
43.1%
31/72
|
|
Musculoskeletal and connective tissue disorders
Pain - Joints
|
11.1%
8/72
|
|
General disorders
Fatigue
|
100.0%
72/72
|
|
Cardiac disorders
Cardiac Toxicity
|
9.7%
7/72
|
|
Gastrointestinal disorders
Diarrhea
|
19.4%
14/72
|
|
Blood and lymphatic system disorders
Edema
|
45.8%
33/72
|
|
Infections and infestations
Febrile Neutropenia
|
11.1%
8/72
|
|
General disorders
Fever
|
27.8%
20/72
|
|
Cardiac disorders
Hypotension
|
6.9%
5/72
|
|
Infections and infestations
Infection (NOS)
|
45.8%
33/72
|
|
Gastrointestinal disorders
Mucositis
|
22.2%
16/72
|
|
Musculoskeletal and connective tissue disorders
Pain - muscles
|
11.1%
8/72
|
|
Gastrointestinal disorders
Nausea
|
52.8%
38/72
|
|
General disorders
Pain - NOS
|
44.4%
32/72
|
|
Nervous system disorders
Peripheral Neuropathy NOS
|
6.9%
5/72
|
|
Cardiac disorders
Pulmonary symptoms
|
22.2%
16/72
|
|
Skin and subcutaneous tissue disorders
Skin Toxicity
|
44.4%
32/72
|
|
Gastrointestinal disorders
Vomiting
|
23.6%
17/72
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at the site.
- Publication restrictions are in place
Restriction type: OTHER