Trial Outcomes & Findings for A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer (NCT NCT00192075)
NCT ID: NCT00192075
Last Updated: 2011-02-07
Results Overview
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)
Results posted on
2011-02-07
Participant Flow
Participant milestones
| Measure |
A+FFG
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
COMPLETED
|
3
|
23
|
|
Overall Study
NOT COMPLETED
|
39
|
19
|
Reasons for withdrawal
| Measure |
A+FFG
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
|---|---|---|
|
Overall Study
Disease Progression
|
23
|
6
|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
|
Overall Study
Patient Non-Compliance
|
0
|
1
|
|
Overall Study
Unacceptable Toxicity Exhibited by Drug
|
2
|
1
|
|
Overall Study
Other
|
5
|
2
|
Baseline Characteristics
A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
A+FFG
n=42 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
n=42 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
62 years
n=5 Participants
|
64 years
n=7 Participants
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
42 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Diagnosis to Enrollment
<6 months
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Diagnosis to Enrollment
>=6 months
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 - Fully Active
|
23 participants
n=5 Participants
|
20 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 - Ambulatory, Restricted Strenuous Activity
|
19 participants
n=5 Participants
|
22 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Primary Tumor Site
Colon
|
25 participants
n=5 Participants
|
35 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Primary Tumor Site
Rectum
|
10 participants
n=5 Participants
|
4 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Primary Tumor Site
Other
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Prior Adjuvant Therapy
Yes
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Prior Adjuvant Therapy
No
|
30 participants
n=5 Participants
|
28 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Race/Ethnicity
African descent
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Site of Metastasis
Liver
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Site of Metastasis
Lung
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Site of Metastasis
Abdominal
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Site of Metastasis
Regional lymph nodes
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Site of Metastasis
Distant lymph nodes
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Site of Metastasis
Genitourinary
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Site of Metastasis
Other
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Tumor Stage
Primary tumor
|
37 participants
n=5 Participants
|
41 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Tumor Stage
Regional lymph nodes
|
24 participants
n=5 Participants
|
29 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Tumor Stage
Distant metastasis
|
25 participants
n=5 Participants
|
20 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)Population: Intent-to-Treat Population
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Outcome measures
| Measure |
A+FFG
n=42 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
n=42 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
|---|---|---|
|
Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)
Complete Response (CR)
|
1 participants
|
2 participants
|
|
Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)
Partial Response (PR)
|
3 participants
|
15 participants
|
|
Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)
Overall Response Rate (CR+PR)
|
4 participants
|
17 participants
|
|
Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)
Stable Disease (SD)
|
21 participants
|
16 participants
|
|
Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)
Disease Control Rate (CR+PR+SD)
|
25 participants
|
33 participants
|
|
Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)
Progressive Disease
|
14 participants
|
7 participants
|
|
Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)
Unknown
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)Population: Intent to treat population. Five patients in A+FFG and 5 patients in A+FOLFOX4 were censored.
Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Outcome measures
| Measure |
A+FFG
n=42 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
n=42 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
|---|---|---|
|
Time to Progressive Disease
|
8.6 months
Interval 5.3 to 17.9
|
9.7 months
Interval 7.3 to 11.2
|
SECONDARY outcome
Timeframe: randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)Population: Intent to treat population. Three patients in A+FFG and 4 patients in A+FOLFOX4 were censored.
Defined as the time from randomization to the first observation of disease progression, or death due to any cause.
Outcome measures
| Measure |
A+FFG
n=42 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
n=42 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
|---|---|---|
|
Progression-Free Survival
|
8.6 months
Interval 4.7 to 17.9
|
9.5 months
Interval 6.9 to 11.2
|
SECONDARY outcome
Timeframe: randomization to the date of death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)Population: Intent to treat population. Eight patients in A+FFG and 12 patients in A+FOLFOX4 were censored.
Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
Outcome measures
| Measure |
A+FFG
n=42 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
n=42 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
|---|---|---|
|
Overall Survival
|
20.6 months
Interval 14.8 to 26.7
|
19.7 months
Interval 11.2 to 32.0
|
SECONDARY outcome
Timeframe: date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)Population: Intent to treat population who were responders (had best overall response of either complete response or partial response). Zero patients in A+FFG and 2 patients in A+FOLFOX4 were censored.
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Outcome measures
| Measure |
A+FFG
n=4 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
n=17 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
|---|---|---|
|
Duration of Response
|
12.7 months
Interval 5.5 to 32.9
|
7.9 months
Interval 4.4 to 9.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)Population: The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Outcome measures
| Measure |
A+FFG
n=18 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
n=18 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
|---|---|---|
|
Tumor Response - Avastin Subgroup
Complete Response (CR)
|
0 participants
|
1 participants
|
|
Tumor Response - Avastin Subgroup
Partial Response (PR)
|
0 participants
|
8 participants
|
|
Tumor Response - Avastin Subgroup
Overall Response Rate (CR+PR)
|
0 participants
|
9 participants
|
|
Tumor Response - Avastin Subgroup
Stable Disease (SD)
|
11 participants
|
8 participants
|
|
Tumor Response - Avastin Subgroup
Disease Control Rate (CR+PR+SD)
|
11 participants
|
17 participants
|
|
Tumor Response - Avastin Subgroup
Progressive Disease
|
6 participants
|
1 participants
|
|
Tumor Response - Avastin Subgroup
Unknown
|
1 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)Population: The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 4 patients in A+FOLFOX4 - Avastin subgroup were censored.
Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Outcome measures
| Measure |
A+FFG
n=18 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
n=18 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
|---|---|---|
|
Time to Progressive Disease - Avastin Subgroup
|
13.7 months
Interval 4.6 to 19.3
|
13.8 months
Interval 6.3 to 23.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)Population: The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Three patients in A+FFG - Avastin subgroup and 3 patients in A+FOLFOX4 - Avastin subgroup were censored.
Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.
Outcome measures
| Measure |
A+FFG
n=18 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
n=18 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
|---|---|---|
|
Progression-Free Survival - Avastin Subgroup
|
13.7 months
Interval 4.6 to 19.3
|
11.5 months
Interval 6.3 to 18.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: randomization to the date of death from any cause (up to 24 months)Population: The original treatment regimens were FFG (Arm A) and FOLFOX (Arm B). Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.
Percentage of participants who were alive at 12 months and 24 months.
Outcome measures
| Measure |
A+FFG
n=18 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
n=18 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
|---|---|---|
|
Survival at 12 Months and 24 Months - Avastin Subgroup
12-Month Survival
|
75.6 percentage of participants alive
Interval 47.3 to 90.1
|
83.3 percentage of participants alive
Interval 56.8 to 94.3
|
|
Survival at 12 Months and 24 Months - Avastin Subgroup
24-Month Survival
|
50.4 percentage of participants alive
Interval 24.9 to 71.4
|
66.7 percentage of participants alive
Interval 40.4 to 83.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: every cycle (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)Population: The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment.
Includes all Grade 3-4 hematologic toxicities and all non-hematologic toxicities with either \>=1 Grade 4 or \>=2 Grade 3 adverse events
Outcome measures
| Measure |
A+FFG
n=18 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
n=18 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
|---|---|---|
|
Toxicity - Avastin Subgroup
Neutropenia (Grade 3)
|
3 participants
|
5 participants
|
|
Toxicity - Avastin Subgroup
Neutropenia (Grade 4)
|
5 participants
|
1 participants
|
|
Toxicity - Avastin Subgroup
Thrombocytopenia (Grade 3)
|
1 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Thrombocytopenia (Grade 4)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Leukopenia (Grade 3)
|
3 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Leukopenia (Grade 4)
|
1 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Anemia (Grade 3)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Anemia (Grade 4)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Febrile neutropenia (Grade 3)
|
0 participants
|
1 participants
|
|
Toxicity - Avastin Subgroup
Febrile neutropenia (Grade 4)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Diarrhea (Grade 3)
|
1 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Diarrhea (Grade 4)
|
0 participants
|
1 participants
|
|
Toxicity - Avastin Subgroup
Small intestinal obstruction (Grade 3)
|
1 participants
|
1 participants
|
|
Toxicity - Avastin Subgroup
Small intestinal obstruction (Grade 4)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Fatigue (Grade 3)
|
0 participants
|
2 participants
|
|
Toxicity - Avastin Subgroup
Fatigue (Grade 4)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Cerebral infarction (Grade 3)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Cerebral infarction (Grade 4)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Hyperglycemia (Grade 3)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Hyperglycemia (Grade 4)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Dehydration (Grade 3)
|
0 participants
|
1 participants
|
|
Toxicity - Avastin Subgroup
Dehydration (Grade 4)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Deep vein thrombosis (Grade 3)
|
0 participants
|
2 participants
|
|
Toxicity - Avastin Subgroup
Deep vein thrombosis (Grade 4)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Myocardial infarction (Grade 3)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Myocardial infarction (Grade 4)
|
0 participants
|
2 participants
|
|
Toxicity - Avastin Subgroup
Subdural hematoma (Grade 3)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Subdural hematoma (Grade 4)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Perirectal abscess (Grade 3)
|
1 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Perirectal abscess (Grade 4)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Hypoxia (Grade 3)
|
0 participants
|
0 participants
|
|
Toxicity - Avastin Subgroup
Hypoxia (Grade 4)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years)Population: The original treatment regimens were FFG and FOLFOX. Due to FDA approval of Avastin, protocol was amended to add Avastin to treatment regimens. This is the population of patients who received Avastin with the original treatment. Results were not calculable for the A+FFG-Avastin subgroup. Two patients were censored in the A+FOLFOX4-Avastin subgroup.
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Outcome measures
| Measure |
A+FFG
n=9 Participants
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
|---|---|---|
|
Duration of Response - A+FOLFOX4 - Avastin Subgroup
|
5.2 months
Interval 4.2 to 13.8
|
—
|
Adverse Events
A+FFG
Serious events: 11 serious events
Other events: 40 other events
Deaths: 0 deaths
A + FOLFOX 4
Serious events: 8 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A+FFG
n=42 participants at risk
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
n=42 participants at risk
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/42
|
4.8%
2/42 • Number of events 2
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/42
|
4.8%
2/42 • Number of events 2
|
|
Cardiac disorders
Palpitations
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
1/42 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Enteritis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Perirectal abscess
|
2.4%
1/42 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.4%
1/42 • Number of events 1
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
General disorders
Pyrexia
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Pneumonia primary atypical
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Tooth abscess
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/42
|
4.8%
2/42 • Number of events 2
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Nervous system disorders
Syncope vasovagal
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Psychiatric disorders
Confusional state
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Vascular disorders
Deep vein thrombosis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Vascular disorders
Thrombophlebitis superficial
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Vascular disorders
Thrombosis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
Other adverse events
| Measure |
A+FFG
n=42 participants at risk
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
|
A + FOLFOX 4
n=42 participants at risk
Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
38.1%
16/42 • Number of events 32
|
9.5%
4/42 • Number of events 6
|
|
Blood and lymphatic system disorders
Leukopenia
|
19.0%
8/42 • Number of events 29
|
11.9%
5/42 • Number of events 5
|
|
Blood and lymphatic system disorders
Neutropenia
|
57.1%
24/42 • Number of events 76
|
38.1%
16/42 • Number of events 34
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
14/42 • Number of events 37
|
19.0%
8/42 • Number of events 13
|
|
Gastrointestinal disorders
Abdominal pain
|
21.4%
9/42 • Number of events 15
|
9.5%
4/42 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
35.7%
15/42 • Number of events 39
|
23.8%
10/42 • Number of events 16
|
|
Gastrointestinal disorders
Diarrhoea
|
35.7%
15/42 • Number of events 30
|
40.5%
17/42 • Number of events 38
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
3/42 • Number of events 5
|
0.00%
0/42
|
|
Gastrointestinal disorders
Nausea
|
45.2%
19/42 • Number of events 39
|
59.5%
25/42 • Number of events 49
|
|
Gastrointestinal disorders
Stomatitis
|
21.4%
9/42 • Number of events 14
|
11.9%
5/42 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
19.0%
8/42 • Number of events 18
|
35.7%
15/42 • Number of events 26
|
|
General disorders
Asthenia
|
2.4%
1/42 • Number of events 1
|
9.5%
4/42 • Number of events 4
|
|
General disorders
Fatigue
|
52.4%
22/42 • Number of events 46
|
57.1%
24/42 • Number of events 48
|
|
General disorders
Oedema peripheral
|
7.1%
3/42 • Number of events 5
|
9.5%
4/42 • Number of events 4
|
|
General disorders
Pain
|
7.1%
3/42 • Number of events 4
|
7.1%
3/42 • Number of events 4
|
|
General disorders
Pyrexia
|
23.8%
10/42 • Number of events 16
|
14.3%
6/42 • Number of events 6
|
|
General disorders
Rigors
|
14.3%
6/42 • Number of events 9
|
7.1%
3/42 • Number of events 4
|
|
Infections and infestations
Upper respiratory tract infection
|
9.5%
4/42 • Number of events 4
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
3/42 • Number of events 3
|
0.00%
0/42
|
|
Investigations
Haematocrit decreased
|
11.9%
5/42 • Number of events 7
|
4.8%
2/42 • Number of events 4
|
|
Investigations
Haemoglobin decreased
|
14.3%
6/42 • Number of events 9
|
9.5%
4/42 • Number of events 13
|
|
Investigations
Neutrophil count decreased
|
19.0%
8/42 • Number of events 20
|
16.7%
7/42 • Number of events 14
|
|
Investigations
Neutrophil percentage decreased
|
7.1%
3/42 • Number of events 5
|
4.8%
2/42 • Number of events 7
|
|
Investigations
Platelet count decreased
|
11.9%
5/42 • Number of events 7
|
11.9%
5/42 • Number of events 7
|
|
Investigations
Red blood cell count decreased
|
7.1%
3/42 • Number of events 3
|
2.4%
1/42 • Number of events 2
|
|
Investigations
Weight decreased
|
11.9%
5/42 • Number of events 5
|
2.4%
1/42 • Number of events 1
|
|
Investigations
White blood cell count decreased
|
19.0%
8/42 • Number of events 18
|
11.9%
5/42 • Number of events 7
|
|
Investigations
White blood cell count increased
|
0.00%
0/42
|
7.1%
3/42 • Number of events 10
|
|
Metabolism and nutrition disorders
Anorexia
|
19.0%
8/42 • Number of events 16
|
19.0%
8/42 • Number of events 8
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/42 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.1%
3/42 • Number of events 4
|
9.5%
4/42 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.8%
2/42 • Number of events 2
|
7.1%
3/42 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.5%
4/42 • Number of events 4
|
11.9%
5/42 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
3/42 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
7/42 • Number of events 14
|
4.8%
2/42 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.4%
9/42 • Number of events 14
|
11.9%
5/42 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
3/42 • Number of events 4
|
0.00%
0/42
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
6/42 • Number of events 10
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
2/42 • Number of events 2
|
7.1%
3/42 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
7.1%
3/42 • Number of events 3
|
9.5%
4/42 • Number of events 4
|
|
Nervous system disorders
Dysgeusia
|
11.9%
5/42 • Number of events 5
|
14.3%
6/42 • Number of events 7
|
|
Nervous system disorders
Headache
|
23.8%
10/42 • Number of events 21
|
7.1%
3/42 • Number of events 4
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/42
|
21.4%
9/42 • Number of events 13
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/42
|
16.7%
7/42 • Number of events 9
|
|
Nervous system disorders
Paraesthesia
|
4.8%
2/42 • Number of events 2
|
26.2%
11/42 • Number of events 25
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/42
|
14.3%
6/42 • Number of events 21
|
|
Psychiatric disorders
Depression
|
4.8%
2/42 • Number of events 2
|
9.5%
4/42 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
7.1%
3/42 • Number of events 5
|
7.1%
3/42 • Number of events 3
|
|
Renal and urinary disorders
Proteinuria
|
11.9%
5/42 • Number of events 7
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
6/42 • Number of events 6
|
11.9%
5/42 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
6/42 • Number of events 6
|
4.8%
2/42 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
11.9%
5/42 • Number of events 5
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
3/42 • Number of events 3
|
11.9%
5/42 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.8%
2/42 • Number of events 2
|
7.1%
3/42 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.9%
5/42 • Number of events 6
|
11.9%
5/42 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
3/42 • Number of events 3
|
4.8%
2/42 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.0%
8/42 • Number of events 10
|
14.3%
6/42 • Number of events 7
|
|
Vascular disorders
Flushing
|
0.00%
0/42
|
7.1%
3/42 • Number of events 3
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60