Trial Outcomes & Findings for Perioperative Panitumumab and Epirubicin, Oxaliplatin and Xeloda (EOX) in Patients With Gastroesophageal Adenocarcinoma (NCT NCT00667420)
NCT ID: NCT00667420
Last Updated: 2014-07-04
Results Overview
Safety and tolerability were measured by assessing the number of participants able to complete 3 cycles of pre-operative chemotherapy
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
after 3 cycles of pre-operative chemotherapy (approx 21 days per cycle)
Results posted on
2014-07-04
Participant Flow
Between June 2008 and July 2010, 17 patients with adenocarcinoma of the stomach were accrued to the protocol at the MGH and Dana Farber Cancer Institute.
Participant milestones
| Measure |
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment
Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
Completion of Pre-operative EOX-P
|
15
|
|
Overall Study
Completion of Surgery/Re-staging
|
11
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment
Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Perioperative Panitumumab and Epirubicin, Oxaliplatin and Xeloda (EOX) in Patients With Gastroesophageal Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment
n=17 Participants
Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Age, Continuous
|
59 years
FULL_RANGE NA • n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: after 3 cycles of pre-operative chemotherapy (approx 21 days per cycle)Safety and tolerability were measured by assessing the number of participants able to complete 3 cycles of pre-operative chemotherapy
Outcome measures
| Measure |
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment
n=17 Participants
Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
|
|---|---|
|
Safety and Tolerability
|
14 participants
|
SECONDARY outcome
Timeframe: time of surgery = after 3 cycles (approx 63 days) of pre-operative EOX-P chemotherapypercentage of participants who have microscopically negative margins (no tumor at/near the edge of what is resected) at the time of surgical resection
Outcome measures
| Measure |
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment
n=17 Participants
Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
|
|---|---|
|
R0 Resection Rate
|
52.9 percentage of participants
Interval 1.0 to
|
SECONDARY outcome
Timeframe: up to 72 monthsPopulation: We enrolled 17 patients
measured from the first day of treatment to the day when conclusive evidence of new disease is found
Outcome measures
| Measure |
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment
n=17 Participants
Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
|
|---|---|
|
Progression-Free Survival
|
27.2 months
Standard Deviation 24.2
|
SECONDARY outcome
Timeframe: at surgical resection, after 3 cycles pre-operative chemotherapy (approx 63 days)For patients who undergo complete resection, those who have no evidence of residual viable tumor in the surgical specimen will be declared to have achieved a complete pathologic response (pCR), and the overall percentage of patients with pCR will be determined.
Outcome measures
| Measure |
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment
n=12 Participants
Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
|
|---|---|
|
Pathologic Complete Response Rate
|
0 participants
|
SECONDARY outcome
Timeframe: duration from enrollment to death (up to 6 years)Overall survival (OS) is the duration from start of treatment to time of death from any cause.
Outcome measures
| Measure |
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment
n=17 Participants
Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
|
|---|---|
|
Overall Survival
|
NA months
At time study was closed, this regimen was not to be used in this patient population and therefore overall survival was not followed.
|
Adverse Events
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment
n=17 participants at risk
Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
|
|---|---|
|
Metabolism and nutrition disorders
Amylase
|
5.9%
1/17 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Gastrointestinal disorders
Colitis
|
5.9%
1/17 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Gastrointestinal disorders
Dehydration
|
5.9%
1/17 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.9%
1/17 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Infections and infestations
Infection - bacteremia
|
5.9%
1/17 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Metabolism and nutrition disorders
Lipase
|
5.9%
1/17 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.8%
2/17 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Cardiac disorders
Tachycardia
|
5.9%
1/17 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Gastrointestinal disorders
diarrhea
|
11.8%
2/17 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
11.8%
2/17 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
Other adverse events
| Measure |
Epirubicin, Oxaliplatin, Capecitabine, Panitumumab Treatment
n=17 participants at risk
Panitumumab in Combination with Epirubicin, Oxaliplatin and Capecitabine (EOX-P)
|
|---|---|
|
Metabolism and nutrition disorders
Elevated SGPT
|
5.9%
1/17 • Number of events 3 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Metabolism and nutrition disorders
Elevated SGOT
|
11.8%
2/17 • Number of events 3 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Gastrointestinal disorders
Abdomen - pain
|
5.9%
1/17 • Number of events 1 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Gastrointestinal disorders
Anorexia
|
17.6%
3/17 • Number of events 4 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Gastrointestinal disorders
Dehydration
|
17.6%
3/17 • Number of events 4 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Gastrointestinal disorders
Diarrhea without prior colostomy
|
17.6%
3/17 • Number of events 4 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Infections and infestations
Febrile neutropenia
|
11.8%
2/17 • Number of events 2 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Gastrointestinal disorders
Fistula - esophageal
|
5.9%
1/17 • Number of events 1 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Blood and lymphatic system disorders
Hemoglobin - low
|
17.6%
3/17 • Number of events 3 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
17.6%
3/17 • Number of events 3 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.8%
2/17 • Number of events 2 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.9%
1/17 • Number of events 1 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
35.3%
6/17 • Number of events 7 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.9%
1/17 • Number of events 1 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
41.2%
7/17 • Number of events 7 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Cardiac disorders
Hypotension
|
5.9%
1/17 • Number of events 1 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
1/17 • Number of events 1 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Infections and infestations
Infection - lung
|
5.9%
1/17 • Number of events 1 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Gastrointestinal disorders
Leak - incl. anastomotic - esophagus
|
5.9%
1/17 • Number of events 1 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Blood and lymphatic system disorders
Leukocytes - low
|
11.8%
2/17 • Number of events 2 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.9%
1/17 • Number of events 2 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • Number of events 3 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Blood and lymphatic system disorders
Neutrophils
|
17.6%
3/17 • Number of events 4 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Blood and lymphatic system disorders
Platelets - low
|
5.9%
1/17 • Number of events 1 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
5.9%
1/17 • Number of events 1 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
5.9%
1/17 • Number of events 1 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
Vascular disorders
Thrombosis/embolism
|
5.9%
1/17 • Number of events 1 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
|
General disorders
Weight loss
|
11.8%
2/17 • Number of events 4 • From start of study drug (day 1) throughout time enrolled on study. (June 2008 - January 2011)
Adverse events seen in this study were not significantly different from those reported by Waddell T, et. al in Lancet Oncol. 2013 May;14(6):481-9. (NCT00824785). Therefore, only grade 3 and 4 adverse events have been reported here.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place