Trial Outcomes & Findings for Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors (NCT NCT01824875)
NCT ID: NCT01824875
Last Updated: 2025-02-06
Results Overview
Progression-free survival (PFS) is defined as the time from randomization to progression or death without evidence of progression. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier method was used to estimate PFS.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
144 participants
Primary outcome timeframe
Assessed every 3 months for 3 years and then every 6 months for years 3-5
Results posted on
2025-02-06
Participant Flow
The study was activated on April 11, 2013 and closed on March 7, 2016 for a total of 144 patients enrolled. The first patient was accrued on August 8, 2013.
Participant milestones
| Measure |
Arm A (Temozolomide)
Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temozolomide and Capecitabine)
Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
72
|
|
Overall Study
Received Treatment and Adverse Event Data Available
|
68
|
71
|
|
Overall Study
Eligible
|
65
|
68
|
|
Overall Study
Eligible Patients With MGMT by IHC Data Available
|
47
|
50
|
|
Overall Study
Eligible Patients With MGMT by Promoter Methylation Data Available
|
27
|
30
|
|
Overall Study
COMPLETED
|
26
|
32
|
|
Overall Study
NOT COMPLETED
|
46
|
40
|
Reasons for withdrawal
| Measure |
Arm A (Temozolomide)
Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temozolomide and Capecitabine)
Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Disease progression
|
22
|
15
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Adverse Event
|
4
|
10
|
|
Overall Study
Alternative therapy
|
3
|
0
|
|
Overall Study
Complicating disease
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Non-compliance
|
1
|
1
|
|
Overall Study
Treatment ended early due to mis-interpretation of protocol
|
1
|
0
|
|
Overall Study
Administrative issues
|
0
|
2
|
|
Overall Study
Ineligible or never started treatment
|
9
|
5
|
|
Overall Study
Other
|
0
|
2
|
Baseline Characteristics
Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
Arm A (Temozolomide)
n=65 Participants
Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temozolomide and Capecitabine)
n=68 Participants
Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed every 3 months for 3 years and then every 6 months for years 3-5Population: Only eligible patients were included in this analysis.
Progression-free survival (PFS) is defined as the time from randomization to progression or death without evidence of progression. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier method was used to estimate PFS.
Outcome measures
| Measure |
Arm A (Temozolomide)
n=65 Participants
Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temozolomide and Capecitabine)
n=68 Participants
Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-free Survival
|
15.1 months
Interval 10.5 to 21.0
|
23.2 months
Interval 16.6 to 32.2
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 3 years and then every 6 months for years 3-5Population: Only eligible patients were included in this analysis.
Response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as either complete response (CR) or partial response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Arm A (Temozolomide)
n=65 Participants
Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temozolomide and Capecitabine)
n=68 Participants
Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Proportion of Patients With Response
|
0.338 proportion of participants
Interval 0.241 to 0.447
|
0.397 proportion of participants
Interval 0.297 to 0.504
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 3 years and then every 6 months for years 3-5Population: Only eligible patients were included in this analysis.
Overall survival is defined as time from randomization to death or date last known alive.
Outcome measures
| Measure |
Arm A (Temozolomide)
n=65 Participants
Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temozolomide and Capecitabine)
n=68 Participants
Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival
|
53.8 months
Interval 35.7 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
58.7 months
Interval 44.7 to
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 3 years and then every 6 months for years 3-5Population: Only eligible patients with MGMT status by IHC data available were included in this analysis.
Response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as either complete response (CR) or partial response (PR). CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. MGMT status was determined by IHC using paraffin-embedded sections of 4µm. A score (H-score) was generated based on the findings and scoring was performed by two pathologists. This H-score ranges from 0 (no staining in the tumor) to 300 (diffuse intense staining of the tumor). The highest score was used if there was disagreement. H-scores were grouped into 3 standard categories for MGMT status: Category 1 - \<=50 Category 2 - 51-100 Category 3 - \>100
Outcome measures
| Measure |
Arm A (Temozolomide)
n=63 Participants
Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temozolomide and Capecitabine)
n=34 Participants
Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Association Between Methyl Guanine Methyltransferase (MGMT) Status by Immunohistochemistry (IHC) and Response
No response
|
30 Participants
|
29 Participants
|
|
Association Between Methyl Guanine Methyltransferase (MGMT) Status by Immunohistochemistry (IHC) and Response
Response
|
33 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 3 years and then every 6 months for years 3-5Population: Only eligible patients with MGMT by promoter methylation data available were included in this analysis.
Response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and defined as either complete response (CR) or partial response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. MGMT status is determined by promoter methylation, a clinically validated methylation-specific polymerase chain reaction (PCR) analysis. A tumor sample is considered positive for MGMT promoter methylation if an 80bp band is detected in the methylated PCR reaction. It would be considered MGMT negative if an 80bp band is not detected in the methylated PCR reaction.
Outcome measures
| Measure |
Arm A (Temozolomide)
n=50 Participants
Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temozolomide and Capecitabine)
n=7 Participants
Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Association Between Methyl Guanine Methyltransferase (MGMT) Status by Promoter Methylation and Response
No response
|
31 Participants
|
1 Participants
|
|
Association Between Methyl Guanine Methyltransferase (MGMT) Status by Promoter Methylation and Response
Response
|
19 Participants
|
6 Participants
|
Adverse Events
Arm A (Temozolomide)
Serious events: 15 serious events
Other events: 63 other events
Deaths: 42 deaths
Arm B (Temozolomide and Capecitabine)
Serious events: 32 serious events
Other events: 70 other events
Deaths: 33 deaths
Serious adverse events
| Measure |
Arm A (Temozolomide)
n=68 participants at risk
ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temozolomide and Capecitabine)
n=71 participants at risk
ARM B: Patients receive capecitabine PO twice daily (BID) on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
Fatigue
|
1.5%
1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
8.5%
6/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.5%
1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.8%
2/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
8.5%
6/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
8.5%
6/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
8.5%
6/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Lung infection
|
1.5%
1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Alkaline phosphatase increased
|
1.5%
1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Blood bilirubin increased
|
1.5%
1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Lymphocyte count decreased
|
4.4%
3/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
7.0%
5/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Neutrophil count decreased
|
4.4%
3/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
12.7%
9/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Platelet count decreased
|
10.3%
7/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
9.9%
7/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Weight loss
|
0.00%
0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
White blood cell decreased
|
1.5%
1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
2.8%
2/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.5%
1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.2%
3/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.5%
1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
4.2%
3/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.5%
1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, spe
|
0.00%
0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Dizziness
|
1.5%
1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
0.00%
0/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
1.4%
1/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
Other adverse events
| Measure |
Arm A (Temozolomide)
n=68 participants at risk
ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
Arm B (Temozolomide and Capecitabine)
n=71 participants at risk
ARM B: Patients receive capecitabine PO twice daily (BID) on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
30.9%
21/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
38.0%
27/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
General disorders
Fatigue
|
64.7%
44/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
63.4%
45/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
4.4%
3/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
32.4%
23/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.5%
1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
16.9%
12/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.6%
12/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
18.3%
13/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Constipation
|
32.4%
22/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
47.9%
34/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
23.5%
16/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
42.3%
30/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Mucositis oral
|
8.8%
6/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
9.9%
7/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Nausea
|
60.3%
41/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
71.8%
51/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Gastrointestinal disorders
Vomiting
|
29.4%
20/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
39.4%
28/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Infections and infestations
Skin infection
|
0.00%
0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
5.6%
4/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Blood bilirubin increased
|
1.5%
1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
14.1%
10/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
7.0%
5/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Neutrophil count decreased
|
10.3%
7/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
18.3%
13/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Investigations
Platelet count decreased
|
36.8%
25/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
33.8%
24/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.6%
14/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
18.3%
13/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Headache
|
26.5%
18/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
14.1%
10/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
|
Nervous system disorders
Lethargy
|
7.4%
5/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
11.3%
8/71 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 5 years
All patients enrolled are included in all-cause mortality analysis. Patients who received treatment with adverse event data available are included in AE analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60