Trial Outcomes & Findings for Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen (NCT NCT00316225)
NCT ID: NCT00316225
Last Updated: 2010-07-09
Results Overview
Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
COMPLETED
PHASE2
31 participants
baseline, up to 18 weeks
2010-07-09
Participant Flow
Participant milestones
| Measure |
Pemetrexed
Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
Pemetrexed
Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Progressive Disease
|
15
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen
Baseline characteristics by cohort
| Measure |
Pemetrexed
n=31 Participants
Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
|
|---|---|
|
Age Continuous
|
62.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
30 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=5 Participants
|
|
Diagnosis
Non-Small Cell Lung Cancer (NSCLC)
|
23 participants
n=5 Participants
|
|
Diagnosis
Mesothelioma
|
8 participants
n=5 Participants
|
|
Disease Stage
Stage III (locally advanced disease)
|
12 participants
n=5 Participants
|
|
Disease Stage
Stage IV (metastatic disease)
|
18 participants
n=5 Participants
|
|
Disease Stage
Unknown
|
1 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 - Fully Active
|
14 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
17 participants
n=5 Participants
|
|
Fluid Severity
Mild
|
15 participants
n=5 Participants
|
|
Fluid Severity
Moderate
|
14 participants
n=5 Participants
|
|
Fluid Severity
Severe
|
2 participants
n=5 Participants
|
|
Primary Basis for Diagnosis
Cytological
|
6 participants
n=5 Participants
|
|
Primary Basis for Diagnosis
Histopathological
|
25 participants
n=5 Participants
|
|
Type of Third-Space Fluid
Pleural Effusion
|
30 participants
n=5 Participants
|
|
Type of Third-Space Fluid
Ascites
|
1 participants
n=5 Participants
|
|
Body Surface Area
|
1.8 meters squared (m^2)
n=5 Participants
|
|
Height
|
171.0 centimeters (cm)
n=5 Participants
|
|
Weight
|
68.0 kilograms (kg)
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, up to 18 weeksPopulation: Patients who received at least one dose of study drug.
Any untoward medical occurrence in a patient who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Pemetrexed
n=31 Participants
Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
|
|---|---|
|
Overview of Adverse Events
TEAE - Possibly related to study drug
|
23 participants
|
|
Overview of Adverse Events
TEAE - All, regardless of causality
|
28 participants
|
|
Overview of Adverse Events
SAE - All, regardless of causality
|
12 participants
|
|
Overview of Adverse Events
SAE - Possibly related to study drug
|
1 participants
|
|
Overview of Adverse Events
Discontinuations Due to SAEs (including death)
|
4 participants
|
|
Overview of Adverse Events
Discontinuations - Possibly related to study drug
|
1 participants
|
|
Overview of Adverse Events
Discontinuations Due to Nonserious AEs
|
0 participants
|
|
Overview of Adverse Events
Deaths - On Study
|
2 participants
|
|
Overview of Adverse Events
Deaths - Possibly related to study drug
|
0 participants
|
|
Overview of Adverse Events
Deaths - Within 30 days of Study Discontinuation
|
0 participants
|
SECONDARY outcome
Timeframe: baseline, up to 18 weeksPopulation: Patients who received at least one dose of study drug.
Number of participants with laboratory and non-laboratory toxicities possibly related to study drug, which were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. Grades range from 0 (none) to 5 (death). Grade 3 is severe and Grade 4 is life-threatening. NOS = Not otherwise specified.
Outcome measures
| Measure |
Pemetrexed
n=31 Participants
Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
|
|---|---|
|
Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities
Pleural Effusion (Non-Malignant)
|
1 participants
|
|
Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities
Leukocytopenia
|
1 participants
|
|
Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities
Neutropenia/Granulocytopenia
|
1 participants
|
|
Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities
Platelets
|
1 participants
|
|
Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities
Ascites (Non-Malignant)
|
1 participants
|
|
Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities
Febrile Neutropenia
|
1 participants
|
|
Number of Participants With Common Toxicity Criteria - National Cancer Institute Grade 3 and Grade 4 Toxicities
Pain Pulmonary/Upper Respiratory-Chest/Thorax NOS
|
1 participants
|
SECONDARY outcome
Timeframe: Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusionPopulation: Patients who received at least one dose of study drug.
Clearance (CL) can be defined as the volume of plasma which is completely cleared of drug (pemetrexed) per unit time. Total body clearance is calculated after intravenous administration of the drug (pemetrexed) and is measured by taking plasma samples at various timepoints and measuring the amount of pemetrexed in the plasma.
Outcome measures
| Measure |
Pemetrexed
n=31 Participants
Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
|
|---|---|
|
Pemetrexed Population Pharmacokinetics (PK): Clearance
|
85.6 milliliter per minute (mL/min)
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: Cycle 1 and Cycle 2: before the end of infusion (approximately 9.5 minutes), 2 hours, 9-10 hours, 24-48 hours, 480-528 hours (20 to 22 days) after start of pemetrexed infusionPopulation: Patients who received at least one dose of study drug.
Volume of distribution is the theoretical size of the compartment necessary to account for total drug amount in the body if it were present throughout the body in the same concentration found in plasma. Volume of distribution is defined as distribution of pemetrexed in the body and is determined by volume of distribution = dose/drug concentration. By knowing dose and measuring concentration of pemetrexed in plasma, volume was calculated. Central volume (V1) was determined by dose/peak serum level of pemetrexed. Peripheral volume (V2) is sum of all tissue spaces outside the central compartment.
Outcome measures
| Measure |
Pemetrexed
n=31 Participants
Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
|
|---|---|
|
Pemetrexed Population Pharmacokinetics: Volume of Distribution
Central Volume of Distribution
|
6.61 Liters (L)
Standard Deviation 1.32
|
|
Pemetrexed Population Pharmacokinetics: Volume of Distribution
Peripheral Volume of Distribution (V2)
|
8.91 Liters (L)
Standard Deviation 1.68
|
|
Pemetrexed Population Pharmacokinetics: Volume of Distribution
Peripheral Volume of Distribution (V3)
|
1.26 Liters (L)
Standard Deviation 0
|
SECONDARY outcome
Timeframe: baseline, up to 18 weeksPopulation: Patients who received at least one dose of study drug.
Adverse events were coded using the Medical Dictionary for Regulatory Activities, Version 11.0.
Outcome measures
| Measure |
Pemetrexed
n=31 Participants
Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
|
|---|---|
|
Discontinuations Due to Adverse Events
Febrile neutropenia (possibly related)
|
1 participants
|
|
Discontinuations Due to Adverse Events
Pneumonia (resulted in death)
|
1 participants
|
|
Discontinuations Due to Adverse Events
Atrial fibrillation
|
1 participants
|
|
Discontinuations Due to Adverse Events
Respiratory failure (resulted in death)
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, up to 18 weeksPopulation: Patients who received at least one dose of study drug.
Overall tumor response was determined using Response Evaluation Criteria In Solid Tumors (RECIST), which defines when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR (complete response) = disappearance of all target lesions. PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions. PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions. SD (stable disease) = small changes that do not meet above criteria.
Outcome measures
| Measure |
Pemetrexed
n=31 Participants
Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
|
|---|---|
|
Overall Tumor Response
Complete Response
|
0 participants
|
|
Overall Tumor Response
Partial Response
|
2 participants
|
|
Overall Tumor Response
Stable Disease
|
8 participants
|
|
Overall Tumor Response
Progressive Disease
|
12 participants
|
|
Overall Tumor Response
Unknown
|
9 participants
|
Adverse Events
Pemetrexed
Serious adverse events
| Measure |
Pemetrexed
n=31 participants at risk
Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
1/31 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.2%
1/31 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.2%
1/31 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
9.7%
3/31 • Number of events 3
|
|
Cardiac disorders
Cardiac failure
|
3.2%
1/31 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
2/31 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
3.2%
1/31 • Number of events 1
|
|
General disorders
Pyrexia
|
6.5%
2/31 • Number of events 3
|
|
Infections and infestations
Infection
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
6.5%
2/31 • Number of events 2
|
|
Infections and infestations
Respiratory tract infection
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.5%
2/31 • Number of events 2
|
|
Surgical and medical procedures
Pericardial excision
|
3.2%
1/31 • Number of events 1
|
Other adverse events
| Measure |
Pemetrexed
n=31 participants at risk
Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.1%
5/31 • Number of events 5
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.5%
2/31 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.7%
3/31 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.5%
2/31 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
22.6%
7/31 • Number of events 8
|
|
Gastrointestinal disorders
Diarrhoea
|
12.9%
4/31 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
32.3%
10/31 • Number of events 11
|
|
Gastrointestinal disorders
Vomiting
|
9.7%
3/31 • Number of events 4
|
|
General disorders
Asthenia
|
25.8%
8/31 • Number of events 11
|
|
General disorders
Chest pain
|
6.5%
2/31 • Number of events 2
|
|
General disorders
Fatigue
|
29.0%
9/31 • Number of events 13
|
|
General disorders
Influenza like illness
|
6.5%
2/31 • Number of events 2
|
|
General disorders
Mucosal inflammation
|
9.7%
3/31 • Number of events 4
|
|
General disorders
Oedema peripheral
|
16.1%
5/31 • Number of events 5
|
|
General disorders
Pain
|
6.5%
2/31 • Number of events 2
|
|
General disorders
Pyrexia
|
9.7%
3/31 • Number of events 9
|
|
Infections and infestations
Respiratory tract infection
|
12.9%
4/31 • Number of events 4
|
|
Metabolism and nutrition disorders
Anorexia
|
22.6%
7/31 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.9%
4/31 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.5%
2/31 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.5%
2/31 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
6.5%
2/31 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
16.1%
5/31 • Number of events 5
|
|
Nervous system disorders
Headache
|
6.5%
2/31 • Number of events 2
|
|
Nervous system disorders
Paraesthesia
|
6.5%
2/31 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.5%
2/31 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.1%
5/31 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.1%
5/31 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.7%
3/31 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
6.5%
2/31 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.7%
3/31 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
2/31 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60