Trial Outcomes & Findings for Combination Chemotherapy and Bevacizumab in Treating Patients With Advanced Neuroendocrine Tumors (NCT NCT00227617)
NCT ID: NCT00227617
Last Updated: 2023-05-22
Results Overview
Rates of discontinuation were calculated as counts and percentages of patients whom discontinued treatment due to adverse events possibly related to the investigational treatments not including neuropathy.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
36 participants
Primary outcome timeframe
From beginning of treatment up to 18 months; Post-study survival follow-up up to 8 years
Results posted on
2023-05-22
Participant Flow
Simon 2-stage design: 13 patients in stage 1. If at least 2 objective tumor responses were observed by 12 cycles of therapy, the cohort was to be expanded to enroll a total of 39 treated patients.
Participant milestones
| Measure |
Carcinoid
Starting on Day 1, administered every two weeks:
* Leucovorin: 200 mg/ m2; over 2 hours
* Oxaliplatin : 85 mg/m2; over 2 hours
* followed by 5-fluorouracil (5-FU): 2400 mg/ m2 CIV; over 46-48 hours
* Bevacizumab: 5 mg/kg IV
5-FU bolus was permanently dropped after nearly all of the first 13 patients required a dose reduction for toxicity:
* 3 in carcinoid
* 10 in PNET
|
PNET
Starting on Day 1, administered every two weeks:
* Leucovorin: 200 mg/ m2; over 2 hours
* Oxaliplatin : 85 mg/m2; over 2 hours
* followed by 5-fluorouracil (5-FU): 2400 mg/ m2 CIV; over 46-48 hours
* Bevacizumab: 5 mg/kg IV
5-FU bolus was permanently dropped after nearly all of the first 13 patients required a dose reduction for toxicity:
* 3 in carcinoid
* 10 in PNET
|
Poorly Differentiated Neuroendocrine Carcinomas (PDNEC)
Starting on Day 1, administered every two weeks:
* Leucovorin: 200 mg/ m2; over 2 hours
* Oxaliplatin : 85 mg/m2; over 2 hours
* followed by 5-fluorouracil (5-FU): 2400 mg/ m2 CIV; over 46-48 hours
* Bevacizumab: 5 mg/kg IV
5-FU bolus was permanently dropped after nearly all of the first 13 patients required a dose reduction for toxicity:
* 3 in carcinoid
* 10 in PNET
|
|---|---|---|---|
|
Stage 1
STARTED
|
22
|
12
|
2
|
|
Stage 1
COMPLETED
|
22
|
12
|
2
|
|
Stage 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
0
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Chemotherapy and Bevacizumab in Treating Patients With Advanced Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
Combined Neuroendocrine Tumors
n=36 Participants
Patients with Carcinoid Neuroendocrine Tumors, Pancreatic Neuroendocrine Tumors, and Poorly Differentiated Neuroendocrine Carcinoma enrolled on the protocol
|
|---|---|
|
Age, Customized
40-49 years old
|
6 Participants
n=99 Participants
|
|
Age, Customized
50-59 years old
|
13 Participants
n=99 Participants
|
|
Age, Customized
60-69 years old
|
13 Participants
n=99 Participants
|
|
Age, Customized
70-79 years old
|
3 Participants
n=99 Participants
|
|
Age, Customized
80-89 years old
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From beginning of treatment up to 18 months; Post-study survival follow-up up to 8 yearsPopulation: Study terminated early due to low accrual. UCSF moved its clinical research database from Velos to OnCore in July 2010 and some of the data for this study was not transferred. Results reported accurate to date
Rates of discontinuation were calculated as counts and percentages of patients whom discontinued treatment due to adverse events possibly related to the investigational treatments not including neuropathy.
Outcome measures
| Measure |
Carcinoid
n=22 Participants
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
PNET
n=12 Participants
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
PDNEC
n=2 Participants
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
All Neuroendocrine Tumors
|
|---|---|---|---|---|
|
Rate of Discontinuation Due to Adverse Events Possibly Related to Study Treatment
|
3 Participants
|
3 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From Baseline until disease progression, up to 8 yearsPopulation: Intent-to-Treat population used for analysis
Best Objective Response by RECIST with Exact 95% Binomial CIs across all tumor types. The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria Target lesions response + Non-Target lesions response + Evaluation of non-target lesions (Yes / No) = Overall response
Outcome measures
| Measure |
Carcinoid
n=36 Participants
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
PNET
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
PDNEC
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
All Neuroendocrine Tumors
|
|---|---|---|---|---|
|
Best Objective Response
Unevaluable
|
2.8 percentage of participants
Interval 0.0 to 14.0
|
—
|
—
|
—
|
|
Best Objective Response
Progressive Disease
|
2.8 percentage of participants
Interval 0.0 to 14.0
|
—
|
—
|
—
|
|
Best Objective Response
Partial Response
|
31 percentage of participants
Interval 16.0 to 48.0
|
—
|
—
|
—
|
|
Best Objective Response
Stable Disease
|
64 percentage of participants
Interval 46.0 to 79.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From beginning of treatment up to 18 months; Post-study survival follow-up up to 8 yearsPopulation: A reliable median and 95% confidence interval for time to progression could not be computed for participants with Poorly Differentiated Neuroendocrine Carcinoma (PDNEC) due to the insufficient number of participants with this condition (N=2)
Time to disease progression will be defined as the time from baseline until documented disease progression or death (whichever occurs first).
Outcome measures
| Measure |
Carcinoid
n=22 Participants
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
PNET
n=12 Participants
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
PDNEC
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
All Neuroendocrine Tumors
|
|---|---|---|---|---|
|
Time to Progression
|
19.3 months
Interval 9.9 to 29.9
|
21 months
Interval 7.4 to 31.4
|
—
|
—
|
SECONDARY outcome
Timeframe: until death, up to 8 yearsPopulation: Intent-to-Treat population used for analysis
The overall survival is defined as the time from baseline until death (Carcinoid, PNET, PDNEC) using Kaplan-Meier Survival analysis methods.
Outcome measures
| Measure |
Carcinoid
n=36 Participants
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
PNET
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
PDNEC
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
All Neuroendocrine Tumors
|
|---|---|---|---|---|
|
Overall Median Survival
|
31.0 months
Interval 23.3 to 34.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From initial complete or partial response to disease progression, up to 8 yearsPopulation: Intent-to-Treat population used for analysis
Time to treatment failure is defined as the time from the initial complete or partial response to documented disease progression or death (whichever occurs first) across treatment groups and inclusive of drug holidays and estimated using Kaplan-Meier survival analysis methods
Outcome measures
| Measure |
Carcinoid
n=36 Participants
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
PNET
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
PDNEC
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
All Neuroendocrine Tumors
|
|---|---|---|---|---|
|
Overall Time to Treatment Failure
|
9.1 months
Interval 6.5 to 13.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline until end of treatment, up to 8 yearsPopulation: Percentages of participants who met criteria of a biochemical marker response are also displayed
Biochemical marker response is defined as \>=50% reduction in marker or hormone(s) that were elevated at baseline. Markers/hormones tested are: Chromagranin A (CGA), 5-HIAA, Insulin, Proinsulin, C-peptide, Pancreatic polypeptide, Gastrin, Glucagon, and Vasointestinal Peptide.
Outcome measures
| Measure |
Carcinoid
n=13 Participants
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
PNET
n=10 Participants
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
PDNEC
n=2 Participants
Starting on Day 1, administered every two weeks:
5-fluorouracil: 2400 mg/ m2 CIV; over 46-48 hours Leucovorin: 200 mg/ m2; over 2 hours Oxaliplatin : 85 mg/m2; over 2 hours Bevacizumab: 5 mg/kg IV over 30-90 minutes
bevacizumab: 5mg/kg IV q 2 wk on day 1. Initial study drug dose will be delivered over 90 +/- 15 minutes x1. If the first infusion is tolerated without fever/chills, the second infusion may be delivered over 60 +/- 10 minutes. If 60 minutes infusion is well tolerated, all subsequent infusions maybe be delivered over 30 +/- 10 minutes.
5-fluorouracil: 2400mg/m2 CIV over 46-48 hours D1-2 q2 weeks.
leucovorin: 200mg/m2 IV q2 wk on day 1 over a 2-hour period.
oxaliplatin: 200mg/m2 IV q 2 wk on day 1 over a 2-hour period
|
All Neuroendocrine Tumors
n=23 Participants
|
|---|---|---|---|---|
|
Biochemical Marker Response
Chromogranin A (CGA)
|
25 percentage of participants
|
78 percentage of participants
|
0 percentage of participants
|
50 percentage of participants
|
|
Biochemical Marker Response
Any hormone and/or CGA
|
31 percentage of participants
|
80 percentage of participants
|
0 percentage of participants
|
52 percentage of participants
|
|
Biochemical Marker Response
Any hormone (not including CGA)
|
23 percentage of participants
|
60 percentage of participants
|
0 percentage of participants
|
33 percentage of participants
|
Adverse Events
Combined Neuroendocrine Tumors
Serious events: 12 serious events
Other events: 36 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Combined Neuroendocrine Tumors
n=36 participants at risk
Patients enrolled on protocol with Carcinoid Neuroendocrine Tumors, Pancreatic Neuroendocrine Tumors, or Poorly Differentiated Neuroendocrine Carcinoma whom received at least one treatment
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.8%
1/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
5.6%
2/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
General disorders
Constitutional Symptoms
|
2.8%
1/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
General disorders
Fatigue
|
2.8%
1/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
General disorders
Fever
|
2.8%
1/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
General disorders
Death not associated with CTCAE term - Disease progression NOS
|
2.8%
1/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Gastrointestinal disorders
Diarrhea
|
2.8%
1/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Gastrointestinal disorders
Perforation, GI - Small bowel NOS
|
5.6%
2/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Gastrointestinal disorders
Ulcer, GI - Duodenum
|
2.8%
1/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Gastrointestinal disorders
Hemorrhage, GI- Upper GI NOS
|
2.8%
1/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Infections and infestations
Febrile neutropenia
|
2.8%
1/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Infections and infestations
Infection - Other (specify,__)
|
5.6%
2/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
2.8%
1/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
8.3%
3/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
2.8%
1/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
2.8%
1/36 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
Other adverse events
| Measure |
Combined Neuroendocrine Tumors
n=36 participants at risk
Patients enrolled on protocol with Carcinoid Neuroendocrine Tumors, Pancreatic Neuroendocrine Tumors, or Poorly Differentiated Neuroendocrine Carcinoma whom received at least one treatment
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
22.2%
8/36 • Number of events 31 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
5.6%
2/36 • Number of events 2 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
12/36 • Number of events 40 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Blood and lymphatic system disorders
Platelets
|
22.2%
8/36 • Number of events 29 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Cardiac disorders
Other
|
2.8%
1/36 • Number of events 1 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Cardiac disorders
Hypertension
|
22.2%
8/36 • Number of events 15 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
General disorders
Fatigue
|
88.9%
32/36 • Number of events 78 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Gastrointestinal disorders
Weight Loss
|
27.8%
10/36 • Number of events 13 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Gastrointestinal disorders
Anorexia
|
47.2%
17/36 • Number of events 25 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Gastrointestinal disorders
Constipation
|
52.8%
19/36 • Number of events 30 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Gastrointestinal disorders
Diarrhea
|
72.2%
26/36 • Number of events 56 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
8.3%
3/36 • Number of events 6 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Gastrointestinal disorders
Perforation, GI - Small bowel NOS
|
5.6%
2/36 • Number of events 2 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Gastrointestinal disorders
Ulcer, GI - Duodenum
|
5.6%
2/36 • Number of events 2 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Upper GI NOS
|
2.8%
1/36 • Number of events 1 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Blood and lymphatic system disorders
Febrile Neurtropenia
|
2.8%
1/36 • Number of events 1 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Metabolism and nutrition disorders
Proteinuria
|
25.0%
9/36 • Number of events 27 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Nervous system disorders
Neuropathy: sensory
|
94.4%
34/36 • Number of events 144 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
|
Gastrointestinal disorders
Pain- Abdominal
|
41.7%
15/36 • Number of events 34 • Up to 8 years
Data migration issue prevented this data from being reported by treatment arm. Adverse Events grade 3 and higher were not reported.
|
Additional Information
Dr. Emily Bergsland
UCSF Helen Diller Family Comprehensive Cancer Center
Phone: 415-885-7810
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place