Trial Outcomes & Findings for RT, Temozolomide, and Bevacizumab Followed by Bevacizumab/Everolimus in First-line Treatment of GBM (NCT NCT00805961)
NCT ID: NCT00805961
Last Updated: 2021-12-08
Results Overview
Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
18 months
Results posted on
2021-12-08
Participant Flow
Participant milestones
| Measure |
Overall Study
Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
|
|---|---|
|
Modality Therapy
STARTED
|
68
|
|
Modality Therapy
COMPLETED
|
64
|
|
Modality Therapy
NOT COMPLETED
|
4
|
|
Treatment-Free Interval
STARTED
|
64
|
|
Treatment-Free Interval
COMPLETED
|
57
|
|
Treatment-Free Interval
NOT COMPLETED
|
7
|
|
Maintenance Treatment
STARTED
|
57
|
|
Maintenance Treatment
COMPLETED
|
23
|
|
Maintenance Treatment
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Overall Study
Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
|
|---|---|
|
Modality Therapy
Withdrawal by Subject
|
1
|
|
Modality Therapy
Adverse Event
|
1
|
|
Modality Therapy
Disease Progression
|
2
|
|
Treatment-Free Interval
Adverse Event
|
3
|
|
Treatment-Free Interval
Intercurrent Illness
|
2
|
|
Treatment-Free Interval
Physician Decision
|
1
|
|
Treatment-Free Interval
Lack of Efficacy
|
1
|
|
Maintenance Treatment
Lack of Efficacy
|
13
|
|
Maintenance Treatment
Intercurrent Illness
|
7
|
|
Maintenance Treatment
Adverse Event
|
6
|
|
Maintenance Treatment
Withdrawal by Subject
|
5
|
|
Maintenance Treatment
Symptomatic Deterioration
|
2
|
|
Maintenance Treatment
Withdrawn Consent
|
1
|
Baseline Characteristics
RT, Temozolomide, and Bevacizumab Followed by Bevacizumab/Everolimus in First-line Treatment of GBM
Baseline characteristics by cohort
| Measure |
Overall Study
n=68 Participants
Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsProgression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.
Outcome measures
| Measure |
Overall Study
n=51 Participants
Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
|
|---|---|
|
Progression-free Survival (PFS)
|
11.3 Months
Interval 9.3 to 13.1
|
SECONDARY outcome
Timeframe: 18 monthsThe toxicity assessments were made according to the common terminology criteria for adverse events (CTCAE version 3.0) of the National Cancer Institute. Number of participants with Grade 1 to 5 adverse events are reported here.
Outcome measures
| Measure |
Overall Study
n=68 Participants
Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
|
|---|---|
|
Number of Participants Experiencing Toxicity After This Novel Multimodality Regimen
|
53 Participants
|
SECONDARY outcome
Timeframe: 18 monthsOverall survival was defined as the interval from the first day of study treatment until the date of death.
Outcome measures
| Measure |
Overall Study
n=68 Participants
Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
|
|---|---|
|
Overall Survival of Patients With Glioblastoma Multiforme Following Treatment With This Novel Multimodality Regimen
|
13.9 Months
Interval 12.4 to
At time of data analysis of 18 months, some patients were still alive making complete data collection to generate complete confidence interval.
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Only 51 patients had measurable tumor and were evaluable for response assessment.
Response to treatment was assessed by MRI using the MacDonald criteria based on the assessment of the MRI scan for measurable, evaluable, and new lesions. The objective response rate is defined as the proportion of patients with improvement and or decreased extent of lesions compared to baseline.
Outcome measures
| Measure |
Overall Study
n=51 Participants
Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
|
|---|---|
|
Objective Response Rate of Patients With Glioblastoma Multiforme Following Treatment With This Novel Multimodality Regimen
|
31 Participants
|
Adverse Events
Overall Study
Serious events: 32 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Overall Study
n=68 participants at risk
Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
|
|---|---|
|
General disorders
Fatigue
|
2.9%
2/68 • Number of events 2
|
|
Cardiac disorders
Myocardial Infarction
|
1.5%
1/68 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombotic Microangiopathy
|
1.5%
1/68 • Number of events 1
|
|
Blood and lymphatic system disorders
CNS Hemorrhage
|
1.5%
1/68 • Number of events 1
|
|
Blood and lymphatic system disorders
Severe Epistaxis with Hematesis
|
1.5%
1/68 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
1.5%
1/68 • Number of events 1
|
|
General disorders
Fever in absence of neutropenia
|
1.5%
1/68 • Number of events 2
|
|
General disorders
Death
|
2.9%
2/68 • Number of events 2
|
|
General disorders
Pain
|
2.9%
2/68 • Number of events 3
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
1/68 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
4.4%
3/68 • Number of events 4
|
|
Infections and infestations
Infection with Unknown ANC
|
1.5%
1/68 • Number of events 1
|
|
Infections and infestations
Infection with Normal ANC
|
2.9%
2/68 • Number of events 2
|
|
Infections and infestations
Febrile Neutropenia
|
1.5%
1/68 • Number of events 1
|
|
Infections and infestations
Infection - Cellulitis
|
1.5%
1/68 • Number of events 1
|
|
Infections and infestations
Infection - Urinary Tract Infection
|
1.5%
1/68 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.5%
1/68 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Necrotizing Fasciitis
|
1.5%
1/68 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.5%
1/68 • Number of events 1
|
|
Nervous system disorders
Seizure
|
8.8%
6/68 • Number of events 7
|
|
Nervous system disorders
Cognitive Disturbance
|
1.5%
1/68 • Number of events 1
|
|
Nervous system disorders
Neuropathy - Motor
|
1.5%
1/68 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
1.5%
1/68 • Number of events 1
|
|
Nervous system disorders
CNS Ischemia
|
2.9%
2/68 • Number of events 2
|
|
Nervous system disorders
Syncope
|
1.5%
1/68 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.5%
1/68 • Number of events 1
|
|
Nervous system disorders
Mental Status
|
1.5%
1/68 • Number of events 1
|
|
Nervous system disorders
Confusion
|
1.5%
1/68 • Number of events 1
|
|
Nervous system disorders
Neurology - Other
|
1.5%
1/68 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
1.5%
1/68 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
2/68 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.4%
3/68 • Number of events 3
|
|
Surgical and medical procedures
Pneumothorax
|
1.5%
1/68 • Number of events 1
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
14.7%
10/68 • Number of events 11
|
Other adverse events
| Measure |
Overall Study
n=68 participants at risk
Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
7.0%
4/57 • Number of events 4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
17.5%
10/57 • Number of events 10
|
|
General disorders
Fatigue
|
47.4%
27/57 • Number of events 27
|
|
Cardiac disorders
Hypertension
|
38.6%
22/57 • Number of events 22
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
5.3%
3/57 • Number of events 3
|
|
Gastrointestinal disorders
Stomatitis/Mucositis
|
12.3%
7/57 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.8%
9/57 • Number of events 9
|
|
Vascular disorders
Thrombosis/Embolism
|
14.0%
8/57 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.8%
5/57 • Number of events 5
|
|
Renal and urinary disorders
Proteinuria
|
19.3%
11/57 • Number of events 11
|
|
General disorders
Hyperlipidemia
|
8.8%
5/57 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
7.0%
4/57 • Number of events 4
|
Additional Information
John D. Hainsworth, MD.
Sarah Cannon Research Institute
Phone: 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 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 all sites.
- Publication restrictions are in place
Restriction type: OTHER