Trial Outcomes & Findings for Ph II Bev + Either Temozolomide/Etoposide for GBM Pts Who Have Failed Bev + Irinotecan (NCT NCT00613028)
NCT ID: NCT00613028
Last Updated: 2013-07-16
Results Overview
Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
6 months
Results posted on
2013-07-16
Participant Flow
Participant milestones
| Measure |
Temozolomide Arm
Bevacizumab + Temozolomide: Patients who progressed or had grade 3 or greater toxicity related to prior daily etoposide dosing, but have not had prior progression or grade 3 toxicity related to prior daily temozolomide therapy. Patients who have not had prior progression or grade 3 or greater toxicity with either daily temozolomide or etoposide or who have no prior exposure to either will be randomized to one of the groups. Bevacizumab will be administered intravenously at 10mg/kg every other week. Temozolomide will be administered ona continuous daily dosing schedule at 50 mg/m\^2/day.
|
Etoposide Arm
Bevacizumab + Etoposide: Patients who progressed or had grade 3 or greater toxicity related to prior daily temozolomide dosing, but have not had prior progression or grade 3 or greater toxicity related to prior daily etoposide therapy. Patients who have not had prior progression or grade 3 or greater toxicity with either daily temozolomide or etoposide or who have no prior exposure to either will be randomized to one of the groups. Bevacizumab will be administered intravenously at 10mg/kg every other week. Etoposide will be administered once daily at 50 mg/m\^2/day for the first 21 days of each 28-day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
13
|
|
Overall Study
COMPLETED
|
10
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ph II Bev + Either Temozolomide/Etoposide for GBM Pts Who Have Failed Bev + Irinotecan
Baseline characteristics by cohort
| Measure |
Temozolomide Arm
n=10 Participants
Pts treated w Bev + Temozolomide
|
Etoposide Arm
n=13 Participants
Pts treated w Bev + Etoposide
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
52.1 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
51.9 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPercentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.
Outcome measures
| Measure |
Temozolomide Arm
n=10 Participants
Pts treated w Bev + Temozolomide
|
Etoposide Arm
n=13 Participants
Pts treated w Bev + Etoposide
|
|---|---|---|
|
The Primary Outcome Measure is 6 Month Progression-free Survival.
|
0 percentage of participants
Interval 0.0 to 0.0
|
7.7 percentage of participants
Interval 4.8 to 29.2
|
SECONDARY outcome
Timeframe: 41 monthsPercentage of participants with an objective response (complete response or partial response) based on modified Macdonald criteria.
Outcome measures
| Measure |
Temozolomide Arm
n=10 Participants
Pts treated w Bev + Temozolomide
|
Etoposide Arm
n=12 Participants
Pts treated w Bev + Etoposide
|
|---|---|---|
|
Radiographic Response
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 41 monthsTime in months from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.
Outcome measures
| Measure |
Temozolomide Arm
n=10 Participants
Pts treated w Bev + Temozolomide
|
Etoposide Arm
n=13 Participants
Pts treated w Bev + Etoposide
|
|---|---|---|
|
Median Progression-free Survival (PFS)
|
4.1 weeks
Interval 3.0 to 7.9
|
8.1 weeks
Interval 4.1 to 12.0
|
SECONDARY outcome
Timeframe: 41 monthsTime in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.
Outcome measures
| Measure |
Temozolomide Arm
n=10 Participants
Pts treated w Bev + Temozolomide
|
Etoposide Arm
n=13 Participants
Pts treated w Bev + Etoposide
|
|---|---|---|
|
Median Overall Survival (OS)
|
12.6 weeks
Interval 4.6 to 23.3
|
19 weeks
Interval 11.0 to 25.7
|
SECONDARY outcome
Timeframe: 41 monthsIncidence of ≥Grade 3 treatment related, non-hematologic toxicity
Outcome measures
| Measure |
Temozolomide Arm
n=10 Participants
Pts treated w Bev + Temozolomide
|
Etoposide Arm
n=13 Participants
Pts treated w Bev + Etoposide
|
|---|---|---|
|
Grade 3 or Greater, Treatment Related, Non-hematologic Toxicities.
|
1 participants
|
2 participants
|
Adverse Events
Temozolomide Arm
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Etoposide Arm
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Temozolomide Arm
n=10 participants at risk
Pts treated w Bev + Temozolomide
|
Etoposide Arm
n=13 participants at risk
Pts treated w Bev + Etoposide
|
|---|---|---|
|
General disorders
Death NOS
|
20.0%
2/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
7.7%
1/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Infections and infestations-Other, specify: Bilateral Abscess in groin (Infection with normal ANC)
|
10.0%
1/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
0.00%
0/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Infections and infestations-Other, specify: Shingles
|
10.0%
1/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
0.00%
0/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Peripheral motor neuropathy
|
10.0%
1/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
0.00%
0/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Seizure
|
0.00%
0/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
7.7%
1/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
Other adverse events
| Measure |
Temozolomide Arm
n=10 participants at risk
Pts treated w Bev + Temozolomide
|
Etoposide Arm
n=13 participants at risk
Pts treated w Bev + Etoposide
|
|---|---|---|
|
Eye disorders
Blurred vision
|
20.0%
2/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
7.7%
1/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
15.4%
2/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fatigue
|
20.0%
2/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
38.5%
5/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Ataxia
|
10.0%
1/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
30.8%
4/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Cognitive disturbance
|
20.0%
2/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
15.4%
2/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dysphasia
|
30.0%
3/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
0.00%
0/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
23.1%
3/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Memory impairment
|
20.0%
2/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
23.1%
3/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Peripheral motor neuropathy
|
20.0%
2/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
46.2%
6/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Agitation
|
0.00%
0/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
15.4%
2/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
15.4%
2/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Depression
|
0.00%
0/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
15.4%
2/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders-Other, specify: Sexual Dysfunction
|
10.0%
1/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
23.1%
3/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/10 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
23.1%
3/13 • 41 months
Adverse events were gathered and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, but were converted to CTCAE version 4.0 for entry into ClinicalTrials.gov
|
Additional Information
David A. Reardon, MD
Preston Robert Tisch Brain Tumor Center at Duke
Phone: 919-668-1409
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place