Trial Outcomes & Findings for Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma (NCT NCT00295503)
NCT ID: NCT00295503
Last Updated: 2020-10-20
Results Overview
This is the percentage of patients alive and progression-free at 6 months from initiation of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
patients progression free at 6 months
Results posted on
2020-10-20
Participant Flow
Patients recruited from investigators clinics
Participant milestones
| Measure |
Cisplatin, Pemetrexed and Bevacizumab
cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma
Baseline characteristics by cohort
| Measure |
Cisplatin, Pemetrexed and Bevacizumab
n=52 Participants
cisplatin 75 mg/m2, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg IV every 3 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=99 Participants
|
|
Age, Continuous
|
66 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: patients progression free at 6 monthsThis is the percentage of patients alive and progression-free at 6 months from initiation of treatment.
Outcome measures
| Measure |
Cisplatin, Pemetrexed, Bevacizumab
n=52 Participants
cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
|
|---|---|
|
Progression Free Survival Rate at 6 Months
|
56 percentage of participants
|
SECONDARY outcome
Timeframe: from time of enrollment to time of best response or death from any cause, whichever came first up to 100 monthsresponse was assessed by the RECIST criteria (version 1.0). Per those criteria, progression is defined 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 |
Cisplatin, Pemetrexed, Bevacizumab
n=52 Participants
cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
|
|---|---|
|
Response Rate
|
40 percentage of participants
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up 100 monthsoverall survival was measured from time of initiation of treatment to death from any cause
Outcome measures
| Measure |
Cisplatin, Pemetrexed, Bevacizumab
n=52 Participants
cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
|
|---|---|
|
Overall Survival
|
14.8 months
Interval 10.0 to 17.0
|
Adverse Events
Experimental Arm
Serious events: 16 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental Arm
n=53 participants at risk
cisplatin, pemetrexed, and bevacizumab
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolus
|
9.4%
5/53 • Number of events 5 • 3 years 6 months
|
|
Vascular disorders
deep venous thrombosis
|
5.7%
3/53 • Number of events 3 • 3 years 6 months
|
|
Nervous system disorders
RPLS
|
1.9%
1/53 • Number of events 1 • 3 years 6 months
|
|
Nervous system disorders
cerebrovascular accident
|
1.9%
1/53 • Number of events 1 • 3 years 6 months
|
|
Gastrointestinal disorders
small bowel obstruction
|
1.9%
1/53 • Number of events 1 • 3 years 6 months
|
|
General disorders
Dehydration
|
7.5%
4/53 • Number of events 4 • 3 years 6 months
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/53 • Number of events 1 • 3 years 6 months
|
|
Metabolism and nutrition disorders
hypoglycemia
|
1.9%
1/53 • Number of events 1 • 3 years 6 months
|
|
Blood and lymphatic system disorders
neutropenic fever
|
1.9%
1/53 • Number of events 1 • 3 years 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain
|
1.9%
1/53 • Number of events 1 • 3 years 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
squamous cell carcinoma of the skin
|
1.9%
1/53 • Number of events 1 • 3 years 6 months
|
Other adverse events
| Measure |
Experimental Arm
n=53 participants at risk
cisplatin, pemetrexed, and bevacizumab
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
11.3%
6/53 • Number of events 6 • 3 years 6 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.8%
2/53 • Number of events 2 • 3 years 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
1/53 • Number of events 1 • 3 years 6 months
|
|
General disorders
Fatigue
|
7.5%
4/53 • Number of events 4 • 3 years 6 months
|
|
Gastrointestinal disorders
Constipation
|
3.8%
2/53 • Number of events 2 • 3 years 6 months
|
|
General disorders
Dehydration
|
3.8%
2/53 • Number of events 2 • 3 years 6 months
|
|
Nervous system disorders
Neuropathy
|
3.8%
2/53 • Number of events 2 • 3 years 6 months
|
|
Immune system disorders
Allergic reaction
|
1.9%
1/53 • Number of events 1 • 3 years 6 months
|
|
General disorders
Anorexia
|
1.9%
1/53 • Number of events 1 • 3 years 6 months
|
|
Renal and urinary disorders
Creatinine
|
1.9%
1/53 • Number of events 1 • 3 years 6 months
|
|
Gastrointestinal disorders
Mucositis
|
1.9%
1/53 • Number of events 1 • 3 years 6 months
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/53 • Number of events 1 • 3 years 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place