Trial Outcomes & Findings for A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma (NCT NCT03693807)
NCT ID: NCT03693807
Last Updated: 2026-02-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
1 year
Results posted on
2026-02-06
Participant Flow
Participant milestones
| Measure |
Group 1: Unresectable Liver Metastases From Colorectal Cancer
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 2: Resectable Liver Metastases From Colorectal Cancer
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 3: Unresectable Cholangiocarcinoma
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
4
|
|
Overall Study
COMPLETED
|
11
|
13
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
2
|
Reasons for withdrawal
| Measure |
Group 1: Unresectable Liver Metastases From Colorectal Cancer
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 2: Resectable Liver Metastases From Colorectal Cancer
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 3: Unresectable Cholangiocarcinoma
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
Baseline Characteristics
A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma
Baseline characteristics by cohort
| Measure |
Group 1: Unresectable Liver Metastases From Colorectal Cancer
n=15 Participants
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 2: Resectable Liver Metastases From Colorectal Cancer
n=16 Participants
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 3: Unresectable Cholangiocarcinoma
n=4 Participants
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53 years
n=192 Participants
|
51 years
n=170 Participants
|
62 years
n=185 Participants
|
53 years
n=177 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=192 Participants
|
5 Participants
n=170 Participants
|
3 Participants
n=185 Participants
|
15 Participants
n=177 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=192 Participants
|
11 Participants
n=170 Participants
|
1 Participants
n=185 Participants
|
20 Participants
n=177 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=192 Participants
|
3 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
5 Participants
n=177 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=192 Participants
|
12 Participants
n=170 Participants
|
3 Participants
n=185 Participants
|
27 Participants
n=177 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=192 Participants
|
1 Participants
n=170 Participants
|
1 Participants
n=185 Participants
|
3 Participants
n=177 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=177 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=192 Participants
|
1 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
1 Participants
n=177 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=177 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
2 Participants
n=177 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=192 Participants
|
12 Participants
n=170 Participants
|
4 Participants
n=185 Participants
|
28 Participants
n=177 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=192 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
0 Participants
n=177 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=192 Participants
|
3 Participants
n=170 Participants
|
0 Participants
n=185 Participants
|
4 Participants
n=177 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=192 Participants
|
16 Participants
n=170 Participants
|
4 Participants
n=185 Participants
|
35 Participants
n=177 Participants
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Group 1: Unresectable Liver Metastases From Colorectal Cancer
n=15 Participants
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 2: Resectable Liver Metastases From Colorectal Cancer
n=16 Participants
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 3: Unresectable Cholangiocarcinoma
n=4 Participants
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
|---|---|---|---|
|
Number of Patients Requiring Stent Replacements
Participants requiring stent replacement
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Patients Requiring Stent Replacements
Participants not requiring stent replacement
|
14 Participants
|
14 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 1 yearAlkaline phosphatase, serum bilirubin of any patient that received 2 cycles of pump therapy.
Outcome measures
| Measure |
Group 1: Unresectable Liver Metastases From Colorectal Cancer
n=15 Participants
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 2: Resectable Liver Metastases From Colorectal Cancer
n=16 Participants
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 3: Unresectable Cholangiocarcinoma
n=4 Participants
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
|---|---|---|---|
|
Number of Participants With Any Grade Liver Toxicity
Participants with any grade liver toxicity
|
12 Participants
|
13 Participants
|
3 Participants
|
|
Number of Participants With Any Grade Liver Toxicity
Participants without any grade liver toxicity
|
3 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearOverall survival is defined as the time from treatment initiation till the day of death or last follow-up whichever occurs first.
Outcome measures
| Measure |
Group 1: Unresectable Liver Metastases From Colorectal Cancer
n=15 Participants
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 2: Resectable Liver Metastases From Colorectal Cancer
n=16 Participants
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 3: Unresectable Cholangiocarcinoma
n=4 Participants
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
|---|---|---|---|
|
Overall Survival at 1 Year Assessed as the Number of Participants Who Were Alive or Dead at 1 Year
Alive
|
2 Participants
|
9 Participants
|
1 Participants
|
|
Overall Survival at 1 Year Assessed as the Number of Participants Who Were Alive or Dead at 1 Year
Dead
|
13 Participants
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 3 yearsProgression free survival is defined as the time from treatment initiation till the day of progression or death whichever occurs first. Patients that are alive without progression at the end of the study will be censored.
Outcome measures
| Measure |
Group 1: Unresectable Liver Metastases From Colorectal Cancer
n=15 Participants
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 2: Resectable Liver Metastases From Colorectal Cancer
n=16 Participants
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 3: Unresectable Cholangiocarcinoma
n=4 Participants
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
|---|---|---|---|
|
Progression Free Survival
|
231 days
Interval 49.0 to 812.0
|
261 days
Interval 49.0 to 812.0
|
531 days
Interval 49.0 to 812.0
|
Adverse Events
Group 1: Unresectable Liver Metastases From Colorectal Cancer
Serious events: 13 serious events
Other events: 0 other events
Deaths: 13 deaths
Group 2: Resectable Liver Metastases From Colorectal Cancer
Serious events: 7 serious events
Other events: 0 other events
Deaths: 7 deaths
Group 3: Unresectable Cholangiocarcinoma
Serious events: 3 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Group 1: Unresectable Liver Metastases From Colorectal Cancer
n=15 participants at risk
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 2: Resectable Liver Metastases From Colorectal Cancer
n=16 participants at risk
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
Group 3: Unresectable Cholangiocarcinoma
n=4 participants at risk
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR): Please see Detailed Description.
Gemcitabine: Please see Detailed Description.
Oxaliplatin: Please see Detailed Description.
Irinotecan (CPT-11): Please see Detailed Description.
Fluorouracil: Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab): Please see Detailed Description.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
6.2%
1/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Infections and infestations
Wound infection
|
0.00%
0/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
25.0%
1/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
General disorders
Death NOS
|
86.7%
13/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
43.8%
7/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
75.0%
3/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
1/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Hepatobiliary disorders
Biliary Obstruction
|
0.00%
0/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
6.2%
1/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Cardiac disorders
Cardiac disorders - Other, specify - Aneurysm of the hepatic artery
|
6.7%
1/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Cardiac disorders
Chest pain - Cardiac
|
0.00%
0/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
6.2%
1/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
6.2%
1/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
6.7%
1/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
6.2%
1/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
General disorders
Edema trunk
|
6.7%
1/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
General disorders
Fever
|
0.00%
0/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
6.2%
1/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
25.0%
1/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
6.2%
1/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
12.5%
2/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
25.0%
1/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Infections and infestations
Infections and infestations - Other, specify - Gastroenteritis
|
0.00%
0/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
25.0%
1/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
6.2%
1/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Gastrointestinal disorders
Retroperitoneal hemorrhage
|
0.00%
0/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
6.2%
1/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
6.7%
1/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify - Catheter Dislodge
|
0.00%
0/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
6.2%
1/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify - Severed catheter
|
6.7%
1/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
6.2%
1/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
0.00%
0/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
18.8%
3/16 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
25.0%
1/4 • 1 year
PI has retired and there has been a delay in disaggregating the data. Results will be updated once the disaggregation is complete.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nancy Kemeny, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4180
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place