Trial Outcomes & Findings for Trial of Poor Performance Status Patients (ToPPS) (NCT NCT00892710)
NCT ID: NCT00892710
Last Updated: 2015-05-15
Results Overview
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
172 participants
Primary outcome timeframe
18 months
Results posted on
2015-05-15
Participant Flow
10 patients were enrolled/randomized, but never treated due to their reqeust, physician's request or if they were deemed ineligible. 4 of these patients were on the Pemetrexed/Bevacizumab arm and 6 were on the Pemetrexed/Bevacizumab/Carboplatin arm
Participant milestones
| Measure |
Pemetrexed
Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
|
Pemetrexed/Bevacizumab
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
|
Pemetrexed/Bevacizumab/Carboplatin
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
48
|
59
|
55
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
48
|
59
|
55
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Poor Performance Status Patients (ToPPS)
Baseline characteristics by cohort
| Measure |
Pemetrexed
n=48 Participants
Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
|
Pemetrexed/Bevacizumab
n=63 Participants
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
|
Pemetrexed/Bevacizumab/Carboplatin
n=61 Participants
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
72 years
n=7 Participants
|
73 years
n=5 Participants
|
72 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
63 participants
n=7 Participants
|
61 participants
n=5 Participants
|
172 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Includes all enrolled patients whether they recieved treatment or not
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Pemetrexed
n=48 Participants
Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
|
Pemetrexed/Bevacizumab
n=63 Participants
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
|
Pemetrexed/Bevacizumab/Carboplatin
n=61 Participants
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
2.8 months
Interval 1.5 to 4.1
|
4.0 months
Interval 2.6 to 6.0
|
4.8 months
Interval 3.1 to 6.5
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Includes all treated patients
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Pemetrexed
n=48 Participants
Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
|
Pemetrexed/Bevacizumab
n=59 Participants
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
|
Pemetrexed/Bevacizumab/Carboplatin
n=55 Participants
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days
|
|---|---|---|---|
|
Overall Response Rate (ORR), the Number of Patients Who Experience an Objective Benefit From Treatment
|
7 participants
|
18 participants
|
24 participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Includes all treated patients
The Length of Time, in Months, That Patients Remain Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Pemetrexed
n=48 Participants
Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
|
Pemetrexed/Bevacizumab
n=59 Participants
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
|
Pemetrexed/Bevacizumab/Carboplatin
n=55 Participants
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days
|
|---|---|---|---|
|
Time to Progression (TTP)
|
3.5 months
Interval 1.6 to 5.5
|
5.3 months
Interval 3.1 to 6.8
|
5.7 months
Interval 3.8 to 7.1
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Includes all treated patients
Defined as the Length of Time, in Months, that Patients were Alive from the Date of First Treatment Until Treatment Discontinuation for Any Reason.
Outcome measures
| Measure |
Pemetrexed
n=48 Participants
Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
|
Pemetrexed/Bevacizumab
n=59 Participants
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
|
Pemetrexed/Bevacizumab/Carboplatin
n=55 Participants
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days
|
|---|---|---|---|
|
Time to Treatment Failure (TTTF)
|
2.4 months
Interval 0.5 to 21.2
|
3.1 months
Interval 0.03 to 18.8
|
3.3 months
Interval 0.2 to 16.1
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Includes all enrolled patients, whether or not they were treated
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Outcome measures
| Measure |
Pemetrexed
n=48 Participants
Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
|
Pemetrexed/Bevacizumab
n=63 Participants
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
|
Pemetrexed/Bevacizumab/Carboplatin
n=61 Participants
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days
|
|---|---|---|---|
|
Overall Survival (OS)
|
7.7 months
Interval 3.0 to 11.2
|
8.6 months
Interval 5.3 to 11.2
|
8.7 months
Interval 5.4 to 13.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Includes all enrolled patients, whether or not they received treatment
Overall Survival = The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Outcome measures
| Measure |
Pemetrexed
n=48 Participants
Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
|
Pemetrexed/Bevacizumab
n=63 Participants
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
|
Pemetrexed/Bevacizumab/Carboplatin
n=61 Participants
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days
|
|---|---|---|---|
|
6-month and 12-month Overall Survival Probability
6-month OS probability
|
0.52 probability out of 1
Interval 0.37 to 0.65
|
0.61 probability out of 1
Interval 0.47 to 0.72
|
0.57 probability out of 1
Interval 0.43 to 0.69
|
|
6-month and 12-month Overall Survival Probability
12-month OS probability
|
0.3 probability out of 1
Interval 0.18 to 0.43
|
0.32 probability out of 1
Interval 0.21 to 0.45
|
0.44 probability out of 1
Interval 0.31 to 0.57
|
Adverse Events
Pemetrexed
Serious events: 30 serious events
Other events: 48 other events
Deaths: 0 deaths
Pemetrexed/Bevacizumab
Serious events: 28 serious events
Other events: 62 other events
Deaths: 0 deaths
Pemetrexed/Bevacizumab/Carboplatin
Serious events: 33 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed
n=48 participants at risk
Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
|
Pemetrexed/Bevacizumab
n=63 participants at risk
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
|
Pemetrexed/Bevacizumab/Carboplatin
n=61 participants at risk
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days
|
|---|---|---|---|
|
Infections and infestations
Infections and infestations - Other, pneumonia
|
16.7%
8/48 • 18 Months
|
7.9%
5/63 • 18 Months
|
6.6%
4/61 • 18 Months
|
|
General disorders
General disorders and administration site conditions - Other, disease progression
|
8.3%
4/48 • 18 Months
|
6.3%
4/63 • 18 Months
|
3.3%
2/61 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, COPD exacerbation
|
4.2%
2/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
8.2%
5/61 • 18 Months
|
|
Vascular disorders
Thromboembolic event
|
4.2%
2/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
4.9%
3/61 • 18 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
2/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
3.3%
2/61 • 18 Months
|
|
General disorders
Non-cardiac chest pain
|
2.1%
1/48 • 18 Months
|
3.2%
2/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/48 • 18 Months
|
4.8%
3/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
6.6%
4/61 • 18 Months
|
|
Infections and infestations
Skin infection
|
8.3%
4/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.1%
1/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
3.3%
2/61 • 18 Months
|
|
General disorders
Fever
|
4.2%
2/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Psychiatric disorders
Psychiatric disorders - Other, change in mental status
|
2.1%
1/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Blood and lymphatic system disorders
Anemia
|
2.1%
1/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Cardiac disorders
Atrial Fibrillation
|
2.1%
1/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/48 • 18 Months
|
3.2%
2/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Gastrointestinal disorders
Esophagitis
|
4.2%
2/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
General disorders
Fatigue
|
2.1%
1/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/48 • 18 Months
|
3.2%
2/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Vascular disorders
Hypotension
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
3.3%
2/61 • 18 Months
|
|
Investigations
Investigations - Other, pancytopenia
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
3.3%
2/61 • 18 Months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, renal failure
|
4.2%
2/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Nervous system disorders
Seizure
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Nervous system disorders
Stroke
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.1%
1/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Metabolism and nutrition disorders
Acidosis
|
2.1%
1/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Cardiac disorders
Atrial flutter
|
2.1%
1/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
General disorders
Death NOS
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Eye disorders
Eye disorders - Other, blindness
|
2.1%
1/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Eye disorders
Eye infection
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, rectal fissure
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, small bowel obstruction
|
2.1%
1/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, unspecified ulcer
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
General disorders
General disorders and administration site conditions - Other, failure to thrive
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Vascular disorders
Hematoma
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.1%
1/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Infections and infestations
Infections and infestations - Other, intestinal clostridium
|
2.1%
1/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Infections and infestations
Infections and infestations - Other, s. maltophilia bacteremia
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Infections and infestations
Infections and infestations - Other, Staphylococcus Hominis Bacteremia
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Investigations
Investigations - Other, transaminitis
|
2.1%
1/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Cardiac disorders
Pericardial effusion
|
2.1%
1/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, acute respiratory insufficiency
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, respiratory distress
|
2.1%
1/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Infections and infestations
Sepsis
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Nervous system disorders
Syncope
|
2.1%
1/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Vascular disorders
Vascular disorders - Other, superior vena cava stenosis
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
|
Infections and infestations
Infections and infestations - Other, gastroenteritis
|
0.00%
0/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
0.00%
0/61 • 18 Months
|
Other adverse events
| Measure |
Pemetrexed
n=48 participants at risk
Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
|
Pemetrexed/Bevacizumab
n=63 participants at risk
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
|
Pemetrexed/Bevacizumab/Carboplatin
n=61 participants at risk
Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days
Bevacizumab: 15 mg/kg IV every 21 days
Carboplatin: AUC=5 IV every 21 days
|
|---|---|---|---|
|
General disorders
Fatigue
|
60.4%
29/48 • 18 Months
|
61.9%
39/63 • 18 Months
|
59.0%
36/61 • 18 Months
|
|
Gastrointestinal disorders
Nausea
|
39.6%
19/48 • 18 Months
|
36.5%
23/63 • 18 Months
|
47.5%
29/61 • 18 Months
|
|
Blood and lymphatic system disorders
Anemia
|
37.5%
18/48 • 18 Months
|
28.6%
18/63 • 18 Months
|
41.0%
25/61 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
29.2%
14/48 • 18 Months
|
41.3%
26/63 • 18 Months
|
31.1%
19/61 • 18 Months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
12/48 • 18 Months
|
38.1%
24/63 • 18 Months
|
34.4%
21/61 • 18 Months
|
|
Metabolism and nutrition disorders
Anorexia
|
31.2%
15/48 • 18 Months
|
41.3%
26/63 • 18 Months
|
23.0%
14/61 • 18 Months
|
|
Investigations
Platelet Count Decreased
|
25.0%
12/48 • 18 Months
|
15.9%
10/63 • 18 Months
|
39.3%
24/61 • 18 Months
|
|
Investigations
Neutrophil Count Decreased
|
14.6%
7/48 • 18 Months
|
20.6%
13/63 • 18 Months
|
34.4%
21/61 • 18 Months
|
|
General disorders
Edema
|
22.9%
11/48 • 18 Months
|
20.6%
13/63 • 18 Months
|
27.9%
17/61 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.6%
7/48 • 18 Months
|
25.4%
16/63 • 18 Months
|
26.2%
16/61 • 18 Months
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
16.7%
8/48 • 18 Months
|
22.2%
14/63 • 18 Months
|
24.6%
15/61 • 18 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
29.2%
14/48 • 18 Months
|
17.5%
11/63 • 18 Months
|
14.8%
9/61 • 18 Months
|
|
Gastrointestinal disorders
Diarrhea
|
20.8%
10/48 • 18 Months
|
17.5%
11/63 • 18 Months
|
19.7%
12/61 • 18 Months
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
12/48 • 18 Months
|
17.5%
11/63 • 18 Months
|
14.8%
9/61 • 18 Months
|
|
Investigations
White Blood Cell Decreased
|
8.3%
4/48 • 18 Months
|
17.5%
11/63 • 18 Months
|
21.3%
13/61 • 18 Months
|
|
Investigations
Weight Loss
|
10.4%
5/48 • 18 Months
|
14.3%
9/63 • 18 Months
|
18.0%
11/61 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
2/48 • 18 Months
|
9.5%
6/63 • 18 Months
|
26.2%
16/61 • 18 Months
|
|
Infections and infestations
Infections And Infestations - Other, Pneumonia
|
20.8%
10/48 • 18 Months
|
14.3%
9/63 • 18 Months
|
8.2%
5/61 • 18 Months
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.4%
5/48 • 18 Months
|
11.1%
7/63 • 18 Months
|
13.1%
8/61 • 18 Months
|
|
Vascular disorders
Thromboembolic Event
|
10.4%
5/48 • 18 Months
|
6.3%
4/63 • 18 Months
|
18.0%
11/61 • 18 Months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/48 • 18 Months
|
17.5%
11/63 • 18 Months
|
13.1%
8/61 • 18 Months
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
6/48 • 18 Months
|
12.7%
8/63 • 18 Months
|
8.2%
5/61 • 18 Months
|
|
Psychiatric disorders
Insomnia
|
18.8%
9/48 • 18 Months
|
7.9%
5/63 • 18 Months
|
6.6%
4/61 • 18 Months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
4/48 • 18 Months
|
14.3%
9/63 • 18 Months
|
6.6%
4/61 • 18 Months
|
|
Nervous system disorders
Headache
|
2.1%
1/48 • 18 Months
|
14.3%
9/63 • 18 Months
|
11.5%
7/61 • 18 Months
|
|
Vascular disorders
Hypertension
|
0.00%
0/48 • 18 Months
|
17.5%
11/63 • 18 Months
|
9.8%
6/61 • 18 Months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.6%
7/48 • 18 Months
|
11.1%
7/63 • 18 Months
|
3.3%
2/61 • 18 Months
|
|
Nervous system disorders
Dizziness
|
6.2%
3/48 • 18 Months
|
12.7%
8/63 • 18 Months
|
8.2%
5/61 • 18 Months
|
|
Gastrointestinal disorders
Mucositis
|
6.2%
3/48 • 18 Months
|
6.3%
4/63 • 18 Months
|
14.8%
9/61 • 18 Months
|
|
General disorders
Non-Cardiac Chest Pain
|
10.4%
5/48 • 18 Months
|
7.9%
5/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.4%
5/48 • 18 Months
|
4.8%
3/63 • 18 Months
|
11.5%
7/61 • 18 Months
|
|
General disorders
Fever
|
20.8%
10/48 • 18 Months
|
4.8%
3/63 • 18 Months
|
3.3%
2/61 • 18 Months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
8.3%
4/48 • 18 Months
|
7.9%
5/63 • 18 Months
|
8.2%
5/61 • 18 Months
|
|
Psychiatric disorders
Depression
|
10.4%
5/48 • 18 Months
|
9.5%
6/63 • 18 Months
|
3.3%
2/61 • 18 Months
|
|
Nervous system disorders
Dysgeusia
|
8.3%
4/48 • 18 Months
|
7.9%
5/63 • 18 Months
|
6.6%
4/61 • 18 Months
|
|
Infections and infestations
Urinary Tract Infection
|
4.2%
2/48 • 18 Months
|
7.9%
5/63 • 18 Months
|
9.8%
6/61 • 18 Months
|
|
Infections and infestations
Skin Infection
|
12.5%
6/48 • 18 Months
|
3.2%
2/63 • 18 Months
|
6.6%
4/61 • 18 Months
|
|
Psychiatric disorders
Anxiety
|
10.4%
5/48 • 18 Months
|
6.3%
4/63 • 18 Months
|
3.3%
2/61 • 18 Months
|
|
Psychiatric disorders
Confusion
|
4.2%
2/48 • 18 Months
|
6.3%
4/63 • 18 Months
|
8.2%
5/61 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Voice Alteration
|
0.00%
0/48 • 18 Months
|
6.3%
4/63 • 18 Months
|
11.5%
7/61 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders - Other, Copd Exacerbation
|
8.3%
4/48 • 18 Months
|
6.3%
4/63 • 18 Months
|
3.3%
2/61 • 18 Months
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
3/48 • 18 Months
|
6.3%
4/63 • 18 Months
|
3.3%
2/61 • 18 Months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/48 • 18 Months
|
6.3%
4/63 • 18 Months
|
8.2%
5/61 • 18 Months
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
4/48 • 18 Months
|
4.8%
3/63 • 18 Months
|
1.6%
1/61 • 18 Months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
3/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
8.2%
5/61 • 18 Months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
3/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
6.6%
4/61 • 18 Months
|
|
Vascular disorders
Hypotension
|
6.2%
3/48 • 18 Months
|
0.00%
0/63 • 18 Months
|
8.2%
5/61 • 18 Months
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
10.4%
5/48 • 18 Months
|
1.6%
1/63 • 18 Months
|
3.3%
2/61 • 18 Months
|
|
Gastrointestinal disorders
Oral Pain
|
2.1%
1/48 • 18 Months
|
7.9%
5/63 • 18 Months
|
3.3%
2/61 • 18 Months
|
|
Cardiac disorders
Cardiac Disorders - Other, Tachycardia
|
2.1%
1/48 • 18 Months
|
3.2%
2/63 • 18 Months
|
8.2%
5/61 • 18 Months
|
Additional Information
John D Hainsworth, MD
Sarah Cannon Research Institute
Phone: 1-877-691-7274
Email: [email protected]
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 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 all sites
- Publication restrictions are in place
Restriction type: OTHER