Trial Outcomes & Findings for 5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer (NCT NCT00308516)
NCT ID: NCT00308516
Last Updated: 2021-12-10
Results Overview
The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
24 months
Results posted on
2021-12-10
Participant Flow
Participant milestones
| Measure |
Preoperative 5FU/Radiation/Bevacizumab
Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.
At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
|
Postoperative 5FU/Radiation/Bevacizumab
All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.
Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
31
|
|
Overall Study
COMPLETED
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
29
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer
Baseline characteristics by cohort
| Measure |
Preoperative 5FU/Radiation/Bevacizumab
n=35 Participants
Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.
At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
|
Postoperative 5FU/Radiation/Bevacizumab
n=31 Participants
All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.
Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
56 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
31 participants
n=7 Participants
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsThe Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment
Outcome measures
| Measure |
Preoperative 5FU/Radiation/Bevacizumab
n=35 Participants
Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.
At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
|
Postoperative 5FU/Radiation/Bevacizumab
n=31 Participants
All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.
Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
|
|---|---|---|
|
Disease-Free Survival (DFS), The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment
|
85 percentage of participants
Interval 67.0 to 93.0
|
97 percentage of participants
Interval 79.0 to 100.0
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: The median survival was not reached for either of the cohorts
Overall Survival (OS) is defined ad the Length of time, in months, that patients were alive from their first date of protocol treatment until death.
Outcome measures
| Measure |
Preoperative 5FU/Radiation/Bevacizumab
n=35 Participants
Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.
At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
|
Postoperative 5FU/Radiation/Bevacizumab
n=31 Participants
All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.
Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
|
|---|---|---|
|
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
|
NA months
The 95% CI is not estimable by Kaplan-Meier method since the median survival was not reached by the 24 month follow up period
|
NA months
The 95% CI is not estimable by Kaplan-Meier method since the median survival was not reached by the 24 month follow up period
|
Adverse Events
Preoperative 5FU/Radiation/Bevacizumab
Serious events: 18 serious events
Other events: 35 other events
Deaths: 0 deaths
Postoperative 5FU/Radiation/Bevacizumab
Serious events: 15 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Preoperative 5FU/Radiation/Bevacizumab
n=35 participants at risk
Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.
At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
|
Postoperative 5FU/Radiation/Bevacizumab
n=31 participants at risk
All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.
Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
|
|---|---|---|
|
Infections and infestations
Infection - Pelvis
|
2.9%
1/35 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Infection - NOS
|
5.7%
2/35 • Number of events 2
|
0.00%
0/31
|
|
Gastrointestinal disorders
Ileus
|
2.9%
1/35 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Obstruction - GI
|
5.7%
2/35 • Number of events 2
|
0.00%
0/31
|
|
Gastrointestinal disorders
Pain - Rectum
|
0.00%
0/35
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Fistula, GI
|
0.00%
0/35
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Perforation, GI
|
2.9%
1/35 • Number of events 1
|
6.5%
2/31 • Number of events 2
|
|
Hepatobiliary disorders
Liver Dysfunction
|
2.9%
1/35 • Number of events 1
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Hemorrhage - Nose
|
0.00%
0/35
|
3.2%
1/31 • Number of events 1
|
|
General disorders
Fever
|
2.9%
1/35 • Number of events 1
|
0.00%
0/31
|
|
Nervous system disorders
Syncope
|
0.00%
0/35
|
3.2%
1/31 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/35
|
3.2%
1/31 • Number of events 2
|
|
Gastrointestinal disorders
Pain - Abdomen
|
0.00%
0/35
|
3.2%
1/31 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/35
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
1/35 • Number of events 1
|
3.2%
1/31 • Number of events 1
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
0.00%
0/35
|
3.2%
1/31 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology - Other
|
2.9%
1/35 • Number of events 1
|
0.00%
0/31
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/35 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Infection - GI
|
0.00%
0/35
|
6.5%
2/31 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
2.9%
1/35 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Infection - Skin
|
2.9%
1/35 • Number of events 1
|
0.00%
0/31
|
|
Nervous system disorders
Mental Status
|
0.00%
0/35
|
3.2%
1/31 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/35
|
3.2%
1/31 • Number of events 1
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/35
|
3.2%
1/31 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/35
|
3.2%
1/31 • Number of events 1
|
|
Surgical and medical procedures
Surgery/Intraoperative Injury - Prostate
|
2.9%
1/35 • Number of events 1
|
0.00%
0/31
|
|
Infections and infestations
Infection - Postoperative
|
2.9%
1/35 • Number of events 1
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Wound Complication
|
0.00%
0/35
|
3.2%
1/31 • Number of events 1
|
|
Infections and infestations
Infection - Renal/Genitourinary
|
2.9%
1/35 • Number of events 1
|
0.00%
0/31
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
5.7%
2/35 • Number of events 2
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/35
|
3.2%
1/31 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/35
|
3.2%
1/31 • Number of events 1
|
|
Renal and urinary disorders
Urinary Frequency
|
2.9%
1/35 • Number of events 1
|
0.00%
0/31
|
Other adverse events
| Measure |
Preoperative 5FU/Radiation/Bevacizumab
n=35 participants at risk
Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.
At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
|
Postoperative 5FU/Radiation/Bevacizumab
n=31 participants at risk
All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.
Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle.
|
|---|---|---|
|
General disorders
Pain - Head
|
5.7%
2/35 • Number of events 4
|
9.7%
3/31 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.6%
3/35 • Number of events 5
|
25.8%
8/31 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/35
|
19.4%
6/31 • Number of events 17
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
5.7%
2/35 • Number of events 5
|
12.9%
4/31 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
5.7%
2/35 • Number of events 2
|
16.1%
5/31 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.6%
3/35 • Number of events 4
|
6.5%
2/31 • Number of events 8
|
|
Metabolism and nutrition disorders
ALT
|
5.7%
2/35 • Number of events 3
|
0.00%
0/31
|
|
Gastrointestinal disorders
Anorexia
|
42.9%
15/35 • Number of events 19
|
35.5%
11/31 • Number of events 24
|
|
Metabolism and nutrition disorders
AST
|
11.4%
4/35 • Number of events 9
|
6.5%
2/31 • Number of events 3
|
|
Metabolism and nutrition disorders
Bilirubin
|
5.7%
2/35 • Number of events 3
|
0.00%
0/31
|
|
General disorders
Rigor/Chills
|
5.7%
2/35 • Number of events 2
|
0.00%
0/31
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
25.7%
9/35 • Number of events 16
|
12.9%
4/31 • Number of events 6
|
|
General disorders
Cold Sensitivity
|
5.7%
2/35 • Number of events 2
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
5.7%
2/35 • Number of events 2
|
6.5%
2/31 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
25.7%
9/35 • Number of events 21
|
25.8%
8/31 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/35
|
16.1%
5/31 • Number of events 5
|
|
Gastrointestinal disorders
Dehydration
|
25.7%
9/35 • Number of events 10
|
25.8%
8/31 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhea
|
68.6%
24/35 • Number of events 54
|
87.1%
27/31 • Number of events 70
|
|
Nervous system disorders
Dizziness
|
0.00%
0/35
|
9.7%
3/31 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
8.6%
3/35 • Number of events 13
|
12.9%
4/31 • Number of events 7
|
|
Gastrointestinal disorders
Dysphagia
|
5.7%
2/35 • Number of events 2
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.7%
2/35 • Number of events 5
|
6.5%
2/31 • Number of events 4
|
|
Blood and lymphatic system disorders
Edema - Limb
|
0.00%
0/35
|
6.5%
2/31 • Number of events 2
|
|
General disorders
Fatigue
|
82.9%
29/35 • Number of events 72
|
71.0%
22/31 • Number of events 66
|
|
General disorders
Fever
|
8.6%
3/35 • Number of events 3
|
16.1%
5/31 • Number of events 7
|
|
Gastrointestinal disorders
Rectal Drainage
|
5.7%
2/35 • Number of events 3
|
6.5%
2/31 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hand-Foot
|
11.4%
4/35 • Number of events 7
|
9.7%
3/31 • Number of events 8
|
|
Blood and lymphatic system disorders
Hemoglobin
|
62.9%
22/35 • Number of events 65
|
58.1%
18/31 • Number of events 47
|
|
Renal and urinary disorders
Hemorrhage - Hematuria
|
5.7%
2/35 • Number of events 6
|
0.00%
0/31
|
|
Blood and lymphatic system disorders
Hemorrhage - Gums
|
0.00%
0/35
|
6.5%
2/31 • Number of events 5
|
|
Blood and lymphatic system disorders
Hemorrhage - Nose
|
20.0%
7/35 • Number of events 17
|
19.4%
6/31 • Number of events 11
|
|
Gastrointestinal disorders
Hemorrhage - GI
|
14.3%
5/35 • Number of events 6
|
16.1%
5/31 • Number of events 5
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.7%
2/35 • Number of events 6
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
10/35 • Number of events 13
|
22.6%
7/31 • Number of events 29
|
|
Cardiac disorders
Hypertension
|
17.1%
6/35 • Number of events 12
|
22.6%
7/31 • Number of events 16
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.4%
4/35 • Number of events 4
|
6.5%
2/31 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
5/35 • Number of events 8
|
6.5%
2/31 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
8.6%
3/35 • Number of events 3
|
9.7%
3/31 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.7%
2/35 • Number of events 2
|
0.00%
0/31
|
|
Cardiac disorders
Hypotension
|
0.00%
0/35
|
6.5%
2/31 • Number of events 4
|
|
Infections and infestations
Infection - Postoperative
|
8.6%
3/35 • Number of events 3
|
0.00%
0/31
|
|
Infections and infestations
Infection - GI
|
0.00%
0/35
|
9.7%
3/31 • Number of events 5
|
|
Infections and infestations
Infection - Skin
|
8.6%
3/35 • Number of events 3
|
6.5%
2/31 • Number of events 2
|
|
Infections and infestations
Infection - Upper Respiratory
|
8.6%
3/35 • Number of events 9
|
9.7%
3/31 • Number of events 4
|
|
Infections and infestations
Infection - Renal/Genitourinary
|
20.0%
7/35 • Number of events 7
|
9.7%
3/31 • Number of events 3
|
|
Infections and infestations
Infection with Normal ANC
|
5.7%
2/35 • Number of events 2
|
16.1%
5/31 • Number of events 5
|
|
General disorders
Insomnia
|
11.4%
4/35 • Number of events 11
|
22.6%
7/31 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Irritation
|
0.00%
0/35
|
6.5%
2/31 • Number of events 2
|
|
Immune system disorders
Leukocytes
|
62.9%
22/35 • Number of events 75
|
67.7%
21/31 • Number of events 72
|
|
Psychiatric disorders
Mental Status
|
0.00%
0/35
|
6.5%
2/31 • Number of events 3
|
|
Psychiatric disorders
Mood Alteration - Anxiety
|
14.3%
5/35 • Number of events 16
|
6.5%
2/31 • Number of events 2
|
|
Psychiatric disorders
Mood Alteration - Depression
|
11.4%
4/35 • Number of events 15
|
6.5%
2/31 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
42.9%
15/35 • Number of events 19
|
38.7%
12/31 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
5.7%
2/35 • Number of events 3
|
0.00%
0/31
|
|
Gastrointestinal disorders
Nausea
|
48.6%
17/35 • Number of events 39
|
58.1%
18/31 • Number of events 38
|
|
Nervous system disorders
Neuropathy - Motor
|
0.00%
0/35
|
6.5%
2/31 • Number of events 2
|
|
Immune system disorders
Neutrophils
|
40.0%
14/35 • Number of events 32
|
48.4%
15/31 • Number of events 36
|
|
General disorders
Pain - NOS
|
71.4%
25/35 • Number of events 79
|
83.9%
26/31 • Number of events 81
|
|
General disorders
Pain - Abdomen
|
14.3%
5/35 • Number of events 8
|
32.3%
10/31 • Number of events 16
|
|
Renal and urinary disorders
Dysuria
|
11.4%
4/35 • Number of events 4
|
16.1%
5/31 • Number of events 5
|
|
General disorders
Pain - Back
|
11.4%
4/35 • Number of events 9
|
0.00%
0/31
|
|
General disorders
Pain - Chest
|
5.7%
2/35 • Number of events 2
|
0.00%
0/31
|
|
General disorders
Pain - Rectum
|
8.6%
3/35 • Number of events 3
|
12.9%
4/31 • Number of events 5
|
|
Blood and lymphatic system disorders
Platelets
|
28.6%
10/35 • Number of events 27
|
41.9%
13/31 • Number of events 31
|
|
Gastrointestinal disorders
Proctitis
|
5.7%
2/35 • Number of events 2
|
9.7%
3/31 • Number of events 4
|
|
Renal and urinary disorders
Proteinuria
|
22.9%
8/35 • Number of events 29
|
29.0%
9/31 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
11.4%
4/35 • Number of events 5
|
6.5%
2/31 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
22.9%
8/35 • Number of events 18
|
32.3%
10/31 • Number of events 12
|
|
Nervous system disorders
Neuropathy - Sensory
|
51.4%
18/35 • Number of events 58
|
58.1%
18/31 • Number of events 65
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/35
|
6.5%
2/31 • Number of events 5
|
|
Gastrointestinal disorders
Taste Alteration
|
17.1%
6/35 • Number of events 13
|
12.9%
4/31 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
20.0%
7/35 • Number of events 10
|
0.00%
0/31
|
|
Renal and urinary disorders
Urinary Frequency
|
8.6%
3/35 • Number of events 4
|
0.00%
0/31
|
|
Renal and urinary disorders
Urinary Retention
|
8.6%
3/35 • Number of events 3
|
0.00%
0/31
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/35
|
6.5%
2/31 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
5.7%
2/35 • Number of events 3
|
0.00%
0/31
|
|
Gastrointestinal disorders
Vomiting
|
22.9%
8/35 • Number of events 10
|
32.3%
10/31 • Number of events 16
|
|
Eye disorders
Watery Eye
|
8.6%
3/35 • Number of events 7
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Weight Loss
|
20.0%
7/35 • Number of events 19
|
16.1%
5/31 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Wound Complication
|
5.7%
2/35 • Number of events 2
|
9.7%
3/31 • Number of events 3
|
Additional Information
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