Trial Outcomes & Findings for Phase II Trial of Neoadjuvant FOLFOX4 and Cetuximab for Localized Adenocarcinoma of Rectum (NCT NCT00580073)
NCT ID: NCT00580073
Last Updated: 2019-12-13
Results Overview
Down-staging of the tumor and tumor response rate is defined as the proportion of participant who have any evidence of complete response (CR), pathologic complete response (pCR), or partial response (PR).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
6 months
Results posted on
2019-12-13
Participant Flow
Participants were enrolled between 4/08 and 11/09 from a large cancer research institution.
Participant milestones
| Measure |
FOLFOX4 + Cetuximab
FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU (5-fluorouracil) Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)
Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle.
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|---|---|
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Overall Study
STARTED
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6
|
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Overall Study
COMPLETED
|
6
|
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Trial of Neoadjuvant FOLFOX4 and Cetuximab for Localized Adenocarcinoma of Rectum
Baseline characteristics by cohort
| Measure |
FOLFOX4 + Cetuximab
n=6 Participants
FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)
Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
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4 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsDown-staging of the tumor and tumor response rate is defined as the proportion of participant who have any evidence of complete response (CR), pathologic complete response (pCR), or partial response (PR).
Outcome measures
| Measure |
FOLFOX4 + Cetuximab
n=6 Participants
FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)
Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle.
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|---|---|
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Down-staging of the Tumor; Response to Therapy
PR
|
4 participants
|
|
Down-staging of the Tumor; Response to Therapy
pCR
|
1 participants
|
|
Down-staging of the Tumor; Response to Therapy
CR
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsNumber of participants who achieve progression free survival, defined as the time from date of registration to date of disease progression, up through study closure. Progressive disease is defined as ≥ 20% increase in the sum of the longest dimensions of the primary lesion taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions.
Outcome measures
| Measure |
FOLFOX4 + Cetuximab
n=6 Participants
FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)
Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle.
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|---|---|
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Progression Free Survival
|
5 participants
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SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: This study was closed because of withdrawal of funding. All participants were off study on 02/03/2011.
Overall survival is defined as the time from date of registration to date of death. In the absence of confirmation of death, survival time will be censored at the last date of follow-up.
Outcome measures
Outcome data not reported
Adverse Events
FOLFOX4 + Cetuximab
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FOLFOX4 + Cetuximab
n=6 participants at risk
FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)
Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle.
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|---|---|
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Blood and lymphatic system disorders
Grade 3/4 neutropenia
|
50.0%
3/6 • Number of events 3 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
|
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Metabolism and nutrition disorders
Grade 3/4 potassium, serum-low (hypokalemia)
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
|
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Nervous system disorders
Grade 3/4 neuropathy
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16.7%
1/6 • Number of events 1 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
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General disorders
Grade 3/4 fatigue
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16.7%
1/6 • Number of events 1 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
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Investigations
Grade 3/4 aspartate aminotransferase (AST)
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
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Investigations
Grade 3/4 alanine aminotransferase (ALT)
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16.7%
1/6 • Number of events 1 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
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Other adverse events
| Measure |
FOLFOX4 + Cetuximab
n=6 participants at risk
FOLFOX4: oxaliplatin (85mg/m2 on days 1 and 15 of each cycle)+ 5FU Bolus (400mg/m2 on days 1, 2, 15, and 16 of each cycle) + 5FU CI (600mg/m2 on days 1, 2, 15, and 16 of each cycle) + Leucovorin (200mg/m2 on days 1, 2, 15, and 16 of each cycle)
Cetuximab: Cetuximab 400mg/m2 on day 1 only, 250mg/mr on days 8, 15, and 22 of each cycle.
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|---|---|
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Skin and subcutaneous tissue disorders
Grade 1/2 rash
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66.7%
4/6 • Number of events 4 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
|
|
Nervous system disorders
Grade 1/2 neuropathy
|
50.0%
3/6 • Number of events 3 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
|
|
Blood and lymphatic system disorders
Grade 1/2 neutropenia
|
50.0%
3/6 • Number of events 3 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
|
|
General disorders
Grade 1/2 fatigue
|
50.0%
3/6 • Number of events 3 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
|
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Gastrointestinal disorders
Grade 1/2 mucositis
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
|
|
Gastrointestinal disorders
Grade 1/2 nausea
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
|
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Gastrointestinal disorders
Grade 1/2 diarrhea
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
|
|
Metabolism and nutrition disorders
Grade 1/2 potassium, serum-low (hypokalemia)
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
|
|
Investigations
Grade 1/2 aspartate aminotransferase (AST)
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
|
|
Investigations
Grade 1/2 alanine transaminase (ALT)
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from Day 0 of treatment through the Study Completion Date (02/03/2011), which is a time period of up to 3 years.
Participants were closely monitored for treatment-related adverse events, especially infusion reactions, during the infusion and the post-infusion observation hour. All
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place