Trial Outcomes & Findings for Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer (NCT NCT00098787)
NCT ID: NCT00098787
Last Updated: 2023-07-05
Results Overview
Objective response rate is defined as proportion of patients who achieve complete response (CR) or partial response (PR). Response was assessed using Solid Tumor Response Criteria (RECIST). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
247 participants
Primary outcome timeframe
Assessed every 3 months if the patient is within 2 years of registration and every 6 months up to 4 years post-registration.
Results posted on
2023-07-05
Participant Flow
This study was activated on July 14, 2005, accrued its first patient on September 8, 2005, and terminated on April 20, 2012, with 247 patients from 25 institutions enrolled to the study.
Only 211 patients were registered to the treatment phase of the study, while the other 36 did not proceed because of ineligibility (n=9), patient withdrawal (n=6), unknown thymidylate synthase (TS)/insufficient sample (n=3), disease progression/decline in TS (n=2), Arm C suspended could not enter Step 2 (n =15), and no insurance (n =1).
Participant milestones
| Measure |
Arm A (High TS, IROX/Bev)
Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
|
Arm B (High TS, FOLFOX/Bev)
Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
|
Arm C (Low or Intermediate TS, FOLFOX/Bev)
Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
|
|---|---|---|---|
|
Overall Study
STARTED
|
73
|
75
|
63
|
|
Overall Study
Treated
|
70
|
73
|
62
|
|
Overall Study
Eligible and Treated
|
61
|
66
|
59
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
73
|
75
|
63
|
Reasons for withdrawal
| Measure |
Arm A (High TS, IROX/Bev)
Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
|
Arm B (High TS, FOLFOX/Bev)
Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
|
Arm C (Low or Intermediate TS, FOLFOX/Bev)
Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
|
|---|---|---|---|
|
Overall Study
Never started treatment
|
3
|
2
|
1
|
|
Overall Study
Ineligible
|
9
|
7
|
3
|
|
Overall Study
Disease progression
|
28
|
17
|
23
|
|
Overall Study
Adverse Event
|
8
|
17
|
8
|
|
Overall Study
Death
|
6
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
12
|
6
|
|
Overall Study
Alternative therapy
|
8
|
13
|
13
|
|
Overall Study
Other
|
7
|
6
|
9
|
Baseline Characteristics
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Arm A (High TS, IROX/Bev)
n=61 Participants
Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
|
Arm B (High TS, FOLFOX/Bev)
n=66 Participants
Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
|
Arm C (Low or Intermediate TS, FOLFOX/Bev)
n=59 Participants
Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=93 Participants
|
60 years
n=4 Participants
|
59 years
n=27 Participants
|
60 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
75 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
111 Participants
n=483 Participants
|
|
Disease status
Initial Diagnosis
|
50 participants
n=93 Participants
|
50 participants
n=4 Participants
|
50 participants
n=27 Participants
|
150 participants
n=483 Participants
|
|
Disease status
Recurrence
|
11 participants
n=93 Participants
|
16 participants
n=4 Participants
|
9 participants
n=27 Participants
|
36 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Assessed every 3 months if the patient is within 2 years of registration and every 6 months up to 4 years post-registration.Population: Eligible and treated patients
Objective response rate is defined as proportion of patients who achieve complete response (CR) or partial response (PR). Response was assessed using Solid Tumor Response Criteria (RECIST). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.
Outcome measures
| Measure |
Arm A (High TS, IROX/Bev)
n=61 Participants
Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
|
Arm B (High TS, FOLFOX/Bev)
n=66 Participants
Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
|
Arm C (Low or Intermediate TS, FOLFOX/Bev)
n=59 Participants
Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
|
|---|---|---|---|
|
Objective Response Rate
|
0.33 proportion
Interval 0.23 to 0.44
|
0.38 proportion
Interval 0.28 to 0.49
|
0.49 proportion
Interval 0.38 to 0.61
|
SECONDARY outcome
Timeframe: Assessed every 3 months if the patient is within 2 years of registration and every 6 months once the patient is 2-4 years post-registration.Population: Eligible and treated patients
Progression-free survival is defined as time from randomization (to Arm A or Arm B) or registration (to Arm C) to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.
Outcome measures
| Measure |
Arm A (High TS, IROX/Bev)
n=61 Participants
Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
|
Arm B (High TS, FOLFOX/Bev)
n=66 Participants
Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
|
Arm C (Low or Intermediate TS, FOLFOX/Bev)
n=59 Participants
Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
|
10 months
Interval 6.0 to 11.0
|
9 months
Interval 8.0 to 11.0
|
13 months
Interval 10.0 to 14.0
|
SECONDARY outcome
Timeframe: Assessed every 3 months if the patient is within 2 years of registration and every 6 months once the patient is 2-4 years post-registration.Population: Eligible and treated patients
Overall survival is defined as time from randomization (to Arm A or Arm B) or registration (to Arm C) to death. Patients alive at last follow-up were censored.
Outcome measures
| Measure |
Arm A (High TS, IROX/Bev)
n=61 Participants
Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
|
Arm B (High TS, FOLFOX/Bev)
n=66 Participants
Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
|
Arm C (Low or Intermediate TS, FOLFOX/Bev)
n=59 Participants
Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
|
|---|---|---|---|
|
Overall Survival (OS)
|
18 months
Interval 14.0 to 23.0
|
21 months
Interval 16.0 to 32.0
|
32 months
Interval 23.0 to 44.0
|
Adverse Events
High TS: IROX/Bev
Serious events: 49 serious events
Other events: 70 other events
Deaths: 0 deaths
High TS: FOLFOX/Bev
Serious events: 53 serious events
Other events: 73 other events
Deaths: 0 deaths
Low or Indeterminate TS: FOLFOX/Bev
Serious events: 43 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High TS: IROX/Bev
n=70 participants at risk
Patients with high thymidylate synthase (TS) who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol.
|
High TS: FOLFOX/Bev
n=73 participants at risk
Patients with high thymidylate synthase (TS) who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in arm I, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
|
Low or Indeterminate TS: FOLFOX/Bev
n=62 participants at risk
Patients with low or intermediate thymidylate synthase (TS) receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
|
|---|---|---|---|
|
Immune system disorders
Anaphylaxis
|
2.9%
2/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
2.7%
2/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
3/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
3.2%
2/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
17.1%
12/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
5.5%
4/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
11.3%
7/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
22.9%
16/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
38.4%
28/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
33.9%
21/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
4.3%
3/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
5.5%
4/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
8.1%
5/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Heart failure
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
21.4%
15/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
9.6%
7/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
6.5%
4/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
General disorders
Chills
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
3.2%
2/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndro
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
6.5%
4/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
General disorders
Death NOS
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
General disorders
Sudden death NOS
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
2/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Colitis
|
2.9%
2/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
2.7%
2/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
4/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
3.2%
2/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
12.9%
9/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
2.7%
2/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
11.3%
7/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Esophagitis
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
2.7%
2/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
2.9%
2/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
2.7%
2/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
3.2%
2/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Colonic obstruction
|
2.9%
2/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
4.1%
3/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
3.2%
2/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Rectal perforation
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Typhlitis
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
5.5%
4/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, spec
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
3.2%
2/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infections and infestations - Other, spe
|
2.9%
2/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
4.1%
3/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Tooth infection
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Lung infection
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
2.7%
2/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Wound infection
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
2.7%
2/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
3.2%
2/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
5.5%
4/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Ataxia
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Anxiety
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.4%
8/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
16.4%
12/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
24.2%
15/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Nervous system disorders - Other, specif
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
6.8%
5/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Headache
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
2/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
2.7%
2/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal di
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Thromboembolic event
|
5.7%
4/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
9.6%
7/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
8.1%
5/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Injury, poisoning and procedural complications
Injury to superior vena cava
|
0.00%
0/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
High TS: IROX/Bev
n=70 participants at risk
Patients with high thymidylate synthase (TS) who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol.
|
High TS: FOLFOX/Bev
n=73 participants at risk
Patients with high thymidylate synthase (TS) who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in arm I, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
|
Low or Indeterminate TS: FOLFOX/Bev
n=62 participants at risk
Patients with low or intermediate thymidylate synthase (TS) receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
|
|---|---|---|---|
|
Immune system disorders
Allergic reaction
|
10.0%
7/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
4.1%
3/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
77.1%
54/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
76.7%
56/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
82.3%
51/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
55.7%
39/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
67.1%
49/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
69.4%
43/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
45.7%
32/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
53.4%
39/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
53.2%
33/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
35.7%
25/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
56.2%
41/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
53.2%
33/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
22.9%
16/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
27.4%
20/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
14.5%
9/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
62.9%
44/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
82.2%
60/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
79.0%
49/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever
|
12.9%
9/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
6.8%
5/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
4.8%
3/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
10.0%
7/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
11.0%
8/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
11.3%
7/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
General disorders
Chills
|
7.1%
5/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
9.6%
7/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
9.7%
6/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
21.4%
15/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
19.2%
14/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
21.0%
13/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
2/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
5.5%
4/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
4.8%
3/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
42.9%
30/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
30.1%
22/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
21.0%
13/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
7.1%
5/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
6.8%
5/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
4.8%
3/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
2.9%
2/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
5.5%
4/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
12.9%
8/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
3/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
8.2%
6/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
6.5%
4/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
7/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
13.7%
10/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
3.2%
2/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndro
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
13.7%
10/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
19.4%
12/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
47.1%
33/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
41.1%
30/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
45.2%
28/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
28.6%
20/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
31.5%
23/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
33.9%
21/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
7/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
11.0%
8/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
9.7%
6/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
68.6%
48/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
57.5%
42/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
61.3%
38/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
7/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
6.5%
4/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
8.6%
6/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
12.3%
9/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
6.5%
4/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
14/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
34.2%
25/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
35.5%
22/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
62.9%
44/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
69.9%
51/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
54.8%
34/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dysgeusia
|
20.0%
14/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
31.5%
23/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
22.6%
14/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
48.6%
34/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
24.7%
18/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
17.7%
11/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, spec
|
5.7%
4/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
0.00%
0/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
3.2%
2/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
8.1%
5/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
14/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
31.5%
23/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
25.8%
16/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
48.6%
34/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
39.7%
29/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
46.8%
29/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
7/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
12.3%
9/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
12.9%
8/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
5.7%
4/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
6.8%
5/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
34.3%
24/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
46.6%
34/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
46.8%
29/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
19.2%
14/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
12.9%
8/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.3%
3/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
5.5%
4/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
17.1%
12/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
16.4%
12/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
21.0%
13/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.9%
2/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
6.8%
5/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
6.5%
4/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.4%
8/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
8.2%
6/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
3.2%
2/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Proteinuria
|
8.6%
6/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
20.5%
15/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
19.4%
12/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.9%
2/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
9.6%
7/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
4.8%
3/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
5/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
5.5%
4/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
6.5%
4/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
15.7%
11/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
5.5%
4/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
6.5%
4/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Anxiety
|
8.6%
6/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.6%
1/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Depression
|
7.1%
5/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
4.1%
3/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
3.2%
2/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
72.9%
51/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
84.9%
62/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
75.8%
47/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
18.6%
13/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
15.1%
11/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
16.1%
10/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Headache
|
8.6%
6/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
15.1%
11/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
11.3%
7/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
5/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
1.4%
1/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
4.8%
3/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
8.2%
6/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
3.2%
2/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
4.1%
3/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
6.5%
4/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
5/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
11.0%
8/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
17.7%
11/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
5.7%
4/70 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
6.8%
5/73 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
3.2%
2/62 • Assessed every 28 days while on treatment and for 30 days after the end of treatment
|
Additional Information
Study Statistician
Eastern Cooperative Oncology Group (ECOG) Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place