Trial Outcomes & Findings for 6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients (NCT NCT00504660)
NCT ID: NCT00504660
Last Updated: 2012-01-11
Results Overview
Progression-free Survival (PFS) at 12 months measured as percentage of participants that are alive and progression-free at 12 months (anaplastic tumors). A combination of neurological examination and MRI brain scan used to define overall response or progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
12 months
Results posted on
2012-01-11
Participant Flow
Recruitment period: September 23, 2003 to June 15, 2009. All patients recruited at UT MD Anderson Cancer Center.
Of the 75 enrolled participants, one was excluded prior to assignment to groups. The Anaplastic Tumors Arms (Arm 1 and Arm 2) were combined for recruitment demographics and data collection.
Participant milestones
| Measure |
Anaplastic Tumors
6-TG 80 mg/m\^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m\^2 PO daily Days 4-8 OR Lomustine 100 mg/m\^2 PO on Day 4; Capecitabine 825 mg/m\^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
|
Glioblastoma Multiforme
6-TG 80 mg/m\^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m\^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m\^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.
Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
43
|
|
Overall Study
COMPLETED
|
31
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients
Baseline characteristics by cohort
| Measure |
Anaplastic Tumors
n=31 Participants
6-TG 80 mg/m\^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m\^2 PO daily Days 4-8 OR Lomustine 100 mg/m\^2 PO on Day 4; Capecitabine 825 mg/m\^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
|
Glioblastoma Multiforme
n=43 Participants
6-TG 80 mg/m\^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m\^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m\^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.
Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
43 participants
n=7 Participants
|
74 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Results from TMZ and CCNU treatment arms (Anaplastic Tumor-Glioma Arms 1 \& 2) were combined in the final analysis because there was no statistically significant difference between them.
Progression-free Survival (PFS) at 12 months measured as percentage of participants that are alive and progression-free at 12 months (anaplastic tumors). A combination of neurological examination and MRI brain scan used to define overall response or progression.
Outcome measures
| Measure |
Participants With Recurrent Anaplastic Glioma
n=31 Participants
6-TG 80 mg/m\^2 orally (PO) every 6 hours Day 1-3; Capecitabine 825 mg/m\^2 and Celebrex 400 mg PO every 12 hours; Arm 1 Temozolomide (TMZ) 150 mg/m\^2 PO daily Days 4-8 OR Arm 2 Lomustine 100 mg/m\^2 PO on Day 4; Arm 2 Participants if previously received Temozolomide but not Lomustine (CCNU) receive Lomustine; or if had Gliadel wafers and Temozolomide with radiotherapy (XRT) receive Temozolomide.
|
|---|---|
|
12 Month-progression-free Survival for Participants With Anaplastic Tumors
|
44 percentage of participants
5
|
PRIMARY outcome
Timeframe: 6 monthsProgression-free Survival (PFS) at 6 months measured as percentage of participants that are alive and progression-free at 6 months (glioblastoma multiforme). A combination of neurological examination and MRI brain scan used to define overall response or progression.
Outcome measures
| Measure |
Participants With Recurrent Anaplastic Glioma
n=43 Participants
6-TG 80 mg/m\^2 orally (PO) every 6 hours Day 1-3; Capecitabine 825 mg/m\^2 and Celebrex 400 mg PO every 12 hours; Arm 1 Temozolomide (TMZ) 150 mg/m\^2 PO daily Days 4-8 OR Arm 2 Lomustine 100 mg/m\^2 PO on Day 4; Arm 2 Participants if previously received Temozolomide but not Lomustine (CCNU) receive Lomustine; or if had Gliadel wafers and Temozolomide with radiotherapy (XRT) receive Temozolomide.
|
|---|---|
|
6 Month Progression-free Survival for Participants With Glioblastoma
|
14 percentage of participants
|
Adverse Events
Anaplastic Tumors
Serious events: 8 serious events
Other events: 31 other events
Deaths: 0 deaths
Glioblastoma Multiforme
Serious events: 16 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Anaplastic Tumors
n=31 participants at risk
6-TG 80 mg/m\^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m\^2 PO daily Days 4-8 OR Lomustine 100 mg/m\^2 PO on Day 4; Capecitabine 825 mg/m\^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
|
Glioblastoma Multiforme
n=43 participants at risk
6-TG 80 mg/m\^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m\^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m\^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.
Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide.
|
|---|---|---|
|
Vascular disorders
Thrombosis/Embolism
|
3.2%
1/31 • Number of events 1 • 6 years and 3 months
|
11.6%
5/43 • Number of events 5 • 6 years and 3 months
|
|
Nervous system disorders
Increased intracranial pressure
|
0.00%
0/31 • 6 years and 3 months
|
2.3%
1/43 • Number of events 1 • 6 years and 3 months
|
|
Nervous system disorders
Seizure
|
3.2%
1/31 • Number of events 1 • 6 years and 3 months
|
2.3%
1/43 • Number of events 1 • 6 years and 3 months
|
|
Nervous system disorders
Mental Status
|
0.00%
0/31 • 6 years and 3 months
|
2.3%
1/43 • Number of events 1 • 6 years and 3 months
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
1/31 • Number of events 1 • 6 years and 3 months
|
7.0%
3/43 • Number of events 3 • 6 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
3.2%
1/31 • Number of events 1 • 6 years and 3 months
|
4.7%
2/43 • Number of events 3 • 6 years and 3 months
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/31 • 6 years and 3 months
|
2.3%
1/43 • Number of events 1 • 6 years and 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
1/31 • Number of events 1 • 6 years and 3 months
|
4.7%
2/43 • Number of events 2 • 6 years and 3 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/31 • 6 years and 3 months
|
2.3%
1/43 • Number of events 1 • 6 years and 3 months
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • Number of events 1 • 6 years and 3 months
|
4.7%
2/43 • Number of events 2 • 6 years and 3 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/31 • 6 years and 3 months
|
2.3%
1/43 • Number of events 1 • 6 years and 3 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/31 • 6 years and 3 months
|
2.3%
1/43 • Number of events 1 • 6 years and 3 months
|
|
General disorders
Fatigue
|
0.00%
0/31 • 6 years and 3 months
|
2.3%
1/43 • Number of events 1 • 6 years and 3 months
|
|
General disorders
Hemorrhage
|
3.2%
1/31 • Number of events 1 • 6 years and 3 months
|
2.3%
1/43 • Number of events 1 • 6 years and 3 months
|
|
Infections and infestations
Pneumonitis
|
3.2%
1/31 • Number of events 1 • 6 years and 3 months
|
0.00%
0/43 • 6 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain-Back
|
3.2%
1/31 • Number of events 1 • 6 years and 3 months
|
2.3%
1/43 • Number of events 1 • 6 years and 3 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.2%
1/31 • Number of events 1 • 6 years and 3 months
|
0.00%
0/43 • 6 years and 3 months
|
|
Nervous system disorders
Confusion
|
3.2%
1/31 • Number of events 1 • 6 years and 3 months
|
2.3%
1/43 • Number of events 1 • 6 years and 3 months
|
Other adverse events
| Measure |
Anaplastic Tumors
n=31 participants at risk
6-TG 80 mg/m\^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m\^2 PO daily Days 4-8 OR Lomustine 100 mg/m\^2 PO on Day 4; Capecitabine 825 mg/m\^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
|
Glioblastoma Multiforme
n=43 participants at risk
6-TG 80 mg/m\^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m\^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m\^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.
Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide.
|
|---|---|---|
|
Metabolism and nutrition disorders
ALKALINE PHOSPHATASE
|
16.1%
5/31 • Number of events 6 • 6 years and 3 months
|
16.3%
7/43 • Number of events 9 • 6 years and 3 months
|
|
Immune system disorders
ALLERGIC RHINITIS
|
12.9%
4/31 • Number of events 4 • 6 years and 3 months
|
14.0%
6/43 • Number of events 6 • 6 years and 3 months
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
16.1%
5/31 • Number of events 5 • 6 years and 3 months
|
16.3%
7/43 • Number of events 8 • 6 years and 3 months
|
|
Metabolism and nutrition disorders
ALT SGPT
|
32.3%
10/31 • Number of events 13 • 6 years and 3 months
|
32.6%
14/43 • Number of events 18 • 6 years and 3 months
|
|
Blood and lymphatic system disorders
ANEMIA
|
19.4%
6/31 • Number of events 16 • 6 years and 3 months
|
7.0%
3/43 • Number of events 4 • 6 years and 3 months
|
|
Gastrointestinal disorders
ANOREXIA
|
9.7%
3/31 • Number of events 4 • 6 years and 3 months
|
11.6%
5/43 • Number of events 5 • 6 years and 3 months
|
|
Metabolism and nutrition disorders
AST SGOT
|
25.8%
8/31 • Number of events 9 • 6 years and 3 months
|
23.3%
10/43 • Number of events 13 • 6 years and 3 months
|
|
Metabolism and nutrition disorders
BICARBONATE SERUM-LOW
|
9.7%
3/31 • Number of events 5 • 6 years and 3 months
|
9.3%
4/43 • Number of events 12 • 6 years and 3 months
|
|
Metabolism and nutrition disorders
BILIRUBIN
|
6.5%
2/31 • Number of events 8 • 6 years and 3 months
|
9.3%
4/43 • Number of events 10 • 6 years and 3 months
|
|
Eye disorders
BLURRED VISION
|
22.6%
7/31 • Number of events 7 • 6 years and 3 months
|
20.9%
9/43 • Number of events 13 • 6 years and 3 months
|
|
Skin and subcutaneous tissue disorders
BRUISING
|
19.4%
6/31 • Number of events 6 • 6 years and 3 months
|
14.0%
6/43 • Number of events 6 • 6 years and 3 months
|
|
Nervous system disorders
COGNITIVE DISTURBANCE
|
16.1%
5/31 • Number of events 6 • 6 years and 3 months
|
11.6%
5/43 • Number of events 5 • 6 years and 3 months
|
|
Nervous system disorders
CONFUSION
|
16.1%
5/31 • Number of events 6 • 6 years and 3 months
|
18.6%
8/43 • Number of events 9 • 6 years and 3 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
48.4%
15/31 • Number of events 32 • 6 years and 3 months
|
34.9%
15/43 • Number of events 18 • 6 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.1%
5/31 • Number of events 6 • 6 years and 3 months
|
20.9%
9/43 • Number of events 9 • 6 years and 3 months
|
|
Metabolism and nutrition disorders
CREATININE
|
9.7%
3/31 • Number of events 5 • 6 years and 3 months
|
2.3%
1/43 • Number of events 1 • 6 years and 3 months
|
|
Gastrointestinal disorders
DIARRHEA
|
25.8%
8/31 • Number of events 14 • 6 years and 3 months
|
32.6%
14/43 • Number of events 18 • 6 years and 3 months
|
|
General disorders
FATIGUE
|
77.4%
24/31 • Number of events 37 • 6 years and 3 months
|
69.8%
30/43 • Number of events 48 • 6 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
GAIT/WALKING
|
38.7%
12/31 • Number of events 19 • 6 years and 3 months
|
30.2%
13/43 • Number of events 18 • 6 years and 3 months
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
77.4%
24/31 • Number of events 60 • 6 years and 3 months
|
76.7%
33/43 • Number of events 88 • 6 years and 3 months
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
45.2%
14/31 • Number of events 33 • 6 years and 3 months
|
100.0%
43/43 • Number of events 47 • 6 years and 3 months
|
|
Cardiac disorders
HYPERTENSION
|
12.9%
4/31 • Number of events 5 • 6 years and 3 months
|
2.3%
1/43 • Number of events 1 • 6 years and 3 months
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
22.6%
7/31 • Number of events 11 • 6 years and 3 months
|
30.2%
13/43 • Number of events 21 • 6 years and 3 months
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
12.9%
4/31 • Number of events 4 • 6 years and 3 months
|
23.3%
10/43 • Number of events 18 • 6 years and 3 months
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
9.7%
3/31 • Number of events 9 • 6 years and 3 months
|
20.9%
9/43 • Number of events 10 • 6 years and 3 months
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
19.4%
6/31 • Number of events 10 • 6 years and 3 months
|
18.6%
8/43 • Number of events 20 • 6 years and 3 months
|
|
Psychiatric disorders
INSOMNIA
|
29.0%
9/31 • Number of events 9 • 6 years and 3 months
|
27.9%
12/43 • Number of events 13 • 6 years and 3 months
|
|
Blood and lymphatic system disorders
LEUKOCYTES
|
67.7%
21/31 • Number of events 113 • 6 years and 3 months
|
76.7%
33/43 • Number of events 124 • 6 years and 3 months
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
12.9%
4/31 • Number of events 16 • 6 years and 3 months
|
0.00%
0/43 • 6 years and 3 months
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
67.7%
21/31 • Number of events 160 • 6 years and 3 months
|
76.7%
33/43 • Number of events 147 • 6 years and 3 months
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
35.5%
11/31 • Number of events 14 • 6 years and 3 months
|
41.9%
18/43 • Number of events 20 • 6 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS
|
32.3%
10/31 • Number of events 20 • 6 years and 3 months
|
60.5%
26/43 • Number of events 45 • 6 years and 3 months
|
|
Gastrointestinal disorders
NAUSEA
|
51.6%
16/31 • Number of events 28 • 6 years and 3 months
|
37.2%
16/43 • Number of events 26 • 6 years and 3 months
|
|
Blood and lymphatic system disorders
NEUTROPHILS (ANC/AGC)
|
48.4%
15/31 • Number of events 70 • 6 years and 3 months
|
65.1%
28/43 • Number of events 72 • 6 years and 3 months
|
|
Blood and lymphatic system disorders
PLATELETS
|
74.2%
23/31 • Number of events 108 • 6 years and 3 months
|
72.1%
31/43 • Number of events 96 • 6 years and 3 months
|
|
Nervous system disorders
PYRAMIDAL TRACT DYSFUNCTION
|
29.0%
9/31 • Number of events 11 • 6 years and 3 months
|
16.3%
7/43 • Number of events 7 • 6 years and 3 months
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
12.9%
4/31 • Number of events 4 • 6 years and 3 months
|
14.0%
6/43 • Number of events 7 • 6 years and 3 months
|
|
Nervous system disorders
SEIZURE
|
32.3%
10/31 • Number of events 14 • 6 years and 3 months
|
39.5%
17/43 • Number of events 29 • 6 years and 3 months
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
12.9%
4/31 • Number of events 5 • 6 years and 3 months
|
7.0%
3/43 • Number of events 4 • 6 years and 3 months
|
|
Gastrointestinal disorders
VOMITING
|
35.5%
11/31 • Number of events 14 • 6 years and 3 months
|
34.9%
15/43 • Number of events 19 • 6 years and 3 months
|
Additional Information
Charles A. Conrad, MD / Professor
UT MD Anderson Cancer Center
Phone: 713-745-1896
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place