Trial Outcomes & Findings for PPX, Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors (NCT NCT00763750)
NCT ID: NCT00763750
Last Updated: 2020-02-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Throughout the entire study until patient is removed from study an average of 6 weeks
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
PPX +TMZ+XRT
XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36
PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PPX, Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors
Baseline characteristics by cohort
| Measure |
PPX +TMZ+XRT
n=25 Participants
XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36
PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 5.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Throughout the entire study until patient is removed from study an average of 6 weeksOutcome measures
| Measure |
PPX +TMZ+XRT
n=25 Participants
XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36
PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)
|
|---|---|
|
Number of Patients Assessed for Toxicity According to CTC Version 3.0
|
25 participants
|
Adverse Events
PPX +TMZ+XRT
Serious events: 6 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PPX +TMZ+XRT
n=25 participants at risk
XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36
PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)
|
|---|---|
|
Investigations
PLT gr 4, ANC 4, HGB 3 F/U: ANC to gr3, HGB and PLT to gr 2
|
4.0%
1/25 • Number of events 1 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
gr 4 PLT, ANC 3, HGB2 & FU: death
|
4.0%
1/25 • Number of events 1 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
Plt gr4, ANC4, weakness/failure to thrive gr 3 & FU:gr 4 Leuko, gr 3 HGB, Anorexia gr 3, death
|
4.0%
1/25 • Number of events 1 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
weakness (gr 3)
|
4.0%
1/25 • Number of events 1 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
seizure - no grade
|
4.0%
1/25 • Number of events 1 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
gr 3 dehydration, gr 3 weakness, gr 3 Anorexia
|
4.0%
1/25 • Number of events 1 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
Other adverse events
| Measure |
PPX +TMZ+XRT
n=25 participants at risk
XRT 60Gy at 2 GY/fractions x 30 fractions TMZ 75mg/m2/day PPX 40mg/m2/week x 6 weeks Days 1,8,15,22,22,29,36
PPX +TMZ+XRT : PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)
|
|---|---|
|
Investigations
rash
|
20.0%
5/25 • Number of events 5 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
infection normal ANC (thrush included)
|
32.0%
8/25 • Number of events 8 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
fatigue
|
28.0%
7/25 • Number of events 7 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
seizure
|
12.0%
3/25 • Number of events 3 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
headache
|
12.0%
3/25 • Number of events 3 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
insomnia
|
8.0%
2/25 • Number of events 2 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
vomiting
|
8.0%
2/25 • Number of events 2 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
Nausea
|
8.0%
2/25 • Number of events 2 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
Alopecia
|
16.0%
4/25 • Number of events 4 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
constipation
|
12.0%
3/25 • Number of events 3 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
Glucose
|
20.0%
5/25 • Number of events 5 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
Albumin
|
16.0%
4/25 • Number of events 4 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
Lymphopenia
|
56.0%
14/25 • Number of events 14 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
PLT
|
16.0%
4/25 • Number of events 4 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
ANC
|
16.0%
4/25 • Number of events 4 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
WBC
|
16.0%
4/25 • Number of events 4 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
|
Investigations
HGB
|
16.0%
4/25 • Number of events 4 • Time of signing consent to 30 days post last dose of drug (approximately 4 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place