Trial Outcomes & Findings for Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer (NCT NCT00463840)
NCT ID: NCT00463840
Last Updated: 2017-12-05
Results Overview
This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
7.5 weeks
Results posted on
2017-12-05
Participant Flow
Total 24 patients were enrolled to this Ph I/II study between June 2004 and December 2009 at New York University Medical Center.
The efficacy and toxicity data were based on both Ph I and II.
Participant milestones
| Measure |
Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6
Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:
Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;
Combined with :
5FU 200 mg/m\^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m\^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m\^2 Oxaliplatin were tested).
Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.
Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):
Day 1 hour 0: Oxaliplatin 85 mg/m\^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m\^2 IV bolus followed by 2400 mg/m\^2 IV over 46 hours.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6
Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:
Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;
Combined with :
5FU 200 mg/m\^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m\^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m\^2 Oxaliplatin were tested).
Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.
Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):
Day 1 hour 0: Oxaliplatin 85 mg/m\^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m\^2 IV bolus followed by 2400 mg/m\^2 IV over 46 hours.
|
|---|---|
|
Overall Study
Disease progression
|
7
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Adverse Event
|
3
|
Baseline Characteristics
Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6
n=24 Participants
Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:
Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;
Combined with :
5FU 200 mg/m\^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m\^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m\^2 Oxaliplatin were tested).
Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.
Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):
Day 1 hour 0: Oxaliplatin 85 mg/m\^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m\^2 IV bolus followed by 2400 mg/m\^2 IV over 46 hours.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
63.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7.5 weeksPopulation: Based on intent-to-treat population.
This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).
Outcome measures
| Measure |
Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6
n=24 Participants
Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:
Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;
Combined with :
5FU 200 mg/m\^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m\^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m\^2 Oxaliplatin were tested).
Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.
Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):
Day 1 hour 0: Oxaliplatin 85 mg/m\^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m\^2 IV bolus followed by 2400 mg/m\^2 IV over 46 hours.
|
|---|---|
|
Resectability After Chemoradiation
|
2 participants
|
SECONDARY outcome
Timeframe: up to 10 years since the start of the studyPopulation: Secondary Measure was not reported. Contacted PI. No new Data available.
This is the time at which 50% of patients are alive from the trial entry .
Outcome measures
Outcome data not reported
Adverse Events
Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6
Serious events: 11 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6
n=24 participants at risk
Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:
Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;
Combined with :
5FU 200 mg/m\^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m\^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m\^2 Oxaliplatin were tested).
Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.
Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):
Day 1 hour 0: Oxaliplatin 85 mg/m\^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m\^2 IV bolus followed by 2400 mg/m\^2 IV over 46 hours.
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytes (Total Wbc)
|
4.2%
1/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Anorexia
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Ascites (Non-Malignant)
|
4.2%
1/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Dehydration
|
20.8%
5/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Diarrhea Patients Without Colostomy
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Gastritis
|
4.2%
1/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Gastrointestinal-Other
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Infections and infestations
Infection With Unknown Anc
|
4.2%
1/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.2%
1/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.2%
1/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Nervous system disorders
Dizziness/Lightheadedness
|
4.2%
1/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Nervous system disorders
Neuropathy - Motor
|
4.2%
1/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Abdominal Pain Or Cramping
|
4.2%
1/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Other
|
4.2%
1/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Renal and urinary disorders
Renal Failure
|
4.2%
1/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
Other adverse events
| Measure |
Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6
n=24 participants at risk
Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:
Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;
Combined with :
5FU 200 mg/m\^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m\^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m\^2 Oxaliplatin were tested).
Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.
Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):
Day 1 hour 0: Oxaliplatin 85 mg/m\^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m\^2 IV bolus followed by 2400 mg/m\^2 IV over 46 hours.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
41.7%
10/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Blood and lymphatic system disorders
Leukocytes (Total Wbc)
|
70.8%
17/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Blood and lymphatic system disorders
Lymphopenia
|
87.5%
21/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Blood and lymphatic system disorders
Neutrophils/Granulocytes (Anc/Agc)
|
45.8%
11/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Blood and lymphatic system disorders
Platelets
|
70.8%
17/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Cardiac disorders
Sinus Tachycardia
|
16.7%
4/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Cardiac disorders
Edema
|
25.0%
6/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Cardiac disorders
Hypotension
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
General disorders
Fatigue (Lethargy, Malaise, Asthenia)
|
87.5%
21/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
General disorders
Fever (In The Absence Of Neutropenia, Where Neutropenia Is Defined As Agc<1.0 X 10e9/L)
|
12.5%
3/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
General disorders
Rigors, Chills
|
12.5%
3/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
General disorders
Weight Loss
|
29.2%
7/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
20.8%
5/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
16.7%
4/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Anorexia
|
87.5%
21/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Ascites (Non-Malignant)
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Constipation
|
54.2%
13/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Dehydration
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Diarrhea Patients Without Colostomy
|
62.5%
15/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Dyspepsia/Heartburn
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
3/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Gastrointestinal-Other
|
12.5%
3/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Mucositis Due To Radiation
|
20.8%
5/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Nausea
|
79.2%
19/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Stomatitis/Pharyngitis (Oral/Pharyngeal Mucositis)
|
37.5%
9/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Vomiting
|
54.2%
13/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Investigations
Alkaline Phosphatase
|
41.7%
10/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
16/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Hepatobiliary disorders
Serum Glutamic Oxaloacetic Transaminase
|
29.2%
7/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Hepatobiliary disorders
Serum Glutamic Pyruvic Transaminase
|
20.8%
5/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Infections and infestations
Infection Without Neutropenia
|
12.5%
3/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Metabolism and nutrition disorders
Bicarbonate
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
45.8%
11/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
3/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
12/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
41.7%
10/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
12/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Nervous system disorders
Dizziness/Lightheadedness
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Nervous system disorders
Insomnia
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Nervous system disorders
Neuropathy - Motor
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Nervous system disorders
Neuropathy-Sensory
|
54.2%
13/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Eye disorders
Cataract
|
16.7%
4/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Gastrointestinal disorders
Abdominal Pain Or Cramping
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
General disorders
Chest Pain (Non-Cardiac And Non-Pleuritic)
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
General disorders
Pain-Other
|
25.0%
6/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (Hiccups, Singultus)
|
8.3%
2/24 • up to 8 months
treating period plus 30 days after the last protocol treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place