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Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00463840
Recruitment Status : Terminated (Due to slow accrual)
First Posted : April 20, 2007
Results First Posted : May 1, 2012
Last Update Posted : December 5, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Oxaliplatin
Drug: 5FU
Radiation: Radiation
Procedure: Surgery
Drug: FOLFOX 6
Enrollment 24
Recruitment Details Total 24 patients were enrolled to this Ph I/II study between June 2004 and December 2009 at New York University Medical Center.
Pre-assignment Details The efficacy and toxicity data were based on both Ph I and II.
Arm/Group Title Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 24
Completed 12
Not Completed 12
Reason Not Completed
Disease progression             7
Withdrawal by Subject             2
Adverse Event             3
Arm/Group Title Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6
Hide Arm/Group Description

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 Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
  62.5%
>=65 years
9
  37.5%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants
63.7
(46 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
10
  41.7%
Male
14
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Resectability After Chemoradiation
Hide Description This is the number of patients whose tumors are resectable after the combination treatment of 5FU, oxaliplatin, and radiation (RT).
Time Frame 7.5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Based on intent-to-treat population.
Arm/Group Title Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6
Hide Arm/Group Description:

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 Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: participants
2
2.Secondary Outcome
Title Median Overall Survival
Hide Description This is the time at which 50% of patients are alive from the trial entry .
Time Frame up to 10 years since the start of the study
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary Measure was not reported. Contacted PI. No new Data available.
Arm/Group Title Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame up to 8 months
Adverse Event Reporting Description treating period plus 30 days after the last protocol treatment
 
Arm/Group Title Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6
Hide Arm/Group Description

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.

All-Cause Mortality
Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6
Affected / at Risk (%)
Total   11/24 (45.83%) 
Blood and lymphatic system disorders   
Leukocytes (Total Wbc)  1  1/24 (4.17%) 
Gastrointestinal disorders   
Anorexia  1  2/24 (8.33%) 
Ascites (Non-Malignant)  1  1/24 (4.17%) 
Dehydration  1  5/24 (20.83%) 
Diarrhea Patients Without Colostomy  1  2/24 (8.33%) 
Gastritis  1  1/24 (4.17%) 
Gastrointestinal-Other  1  2/24 (8.33%) 
Nausea  1  1/24 (4.17%) 
Vomiting  1  2/24 (8.33%) 
Abdominal Pain Or Cramping  1  1/24 (4.17%) 
Infections and infestations   
Infection With Unknown Anc  1  1/24 (4.17%) 
Metabolism and nutrition disorders   
Hyperglycemia  1  1/24 (4.17%) 
Hypernatremia  1  1/24 (4.17%) 
Nervous system disorders   
Dizziness/Lightheadedness  1  1/24 (4.17%) 
Neuropathy - Motor  1  1/24 (4.17%) 
Renal and urinary disorders   
Renal Failure  1  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary-Other  1  1/24 (4.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6
Affected / at Risk (%)
Total   24/24 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  10/24 (41.67%) 
Leukocytes (Total Wbc)  1  17/24 (70.83%) 
Lymphopenia  1  21/24 (87.50%) 
Neutrophils/Granulocytes (Anc/Agc)  1  11/24 (45.83%) 
Platelets  1  17/24 (70.83%) 
Cardiac disorders   
Sinus Tachycardia  1  4/24 (16.67%) 
Edema  1  6/24 (25.00%) 
Hypotension  1  2/24 (8.33%) 
Eye disorders   
Cataract  1  4/24 (16.67%) 
Gastrointestinal disorders   
Anorexia  1  21/24 (87.50%) 
Ascites (Non-Malignant)  1  2/24 (8.33%) 
Constipation  1  13/24 (54.17%) 
Dehydration  1  2/24 (8.33%) 
Diarrhea Patients Without Colostomy  1  15/24 (62.50%) 
Dyspepsia/Heartburn  1  2/24 (8.33%) 
Flatulence  1  3/24 (12.50%) 
Gastrointestinal-Other  1  3/24 (12.50%) 
Mucositis Due To Radiation  1  5/24 (20.83%) 
Nausea  1  19/24 (79.17%) 
Stomatitis/Pharyngitis (Oral/Pharyngeal Mucositis)  1  9/24 (37.50%) 
Vomiting  1  13/24 (54.17%) 
Abdominal Pain Or Cramping  1  2/24 (8.33%) 
General disorders   
Fatigue (Lethargy, Malaise, Asthenia)  1  21/24 (87.50%) 
Fever (In The Absence Of Neutropenia, Where Neutropenia Is Defined As Agc<1.0 X 10e9/L)  1  3/24 (12.50%) 
Rigors, Chills  1  3/24 (12.50%) 
Weight Loss  1  7/24 (29.17%) 
Chest Pain (Non-Cardiac And Non-Pleuritic)  1  2/24 (8.33%) 
Pain-Other  1  6/24 (25.00%) 
Hepatobiliary disorders   
Serum Glutamic Oxaloacetic Transaminase  1  7/24 (29.17%) 
Serum Glutamic Pyruvic Transaminase  1  5/24 (20.83%) 
Infections and infestations   
Infection Without Neutropenia  1  3/24 (12.50%) 
Investigations   
Alkaline Phosphatase  1  10/24 (41.67%) 
Metabolism and nutrition disorders   
Hypoalbuminemia  1  16/24 (66.67%) 
Bicarbonate  1  2/24 (8.33%) 
Hyperglycemia  1  11/24 (45.83%) 
Hyperkalemia  1  3/24 (12.50%) 
Hypernatremia  1  2/24 (8.33%) 
Hypocalcemia  1  12/24 (50.00%) 
Hypokalemia  1  10/24 (41.67%) 
Hyponatremia  1  12/24 (50.00%) 
Nervous system disorders   
Dizziness/Lightheadedness  1  2/24 (8.33%) 
Insomnia  1  2/24 (8.33%) 
Neuropathy - Motor  1  2/24 (8.33%) 
Neuropathy-Sensory  1  13/24 (54.17%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/24 (8.33%) 
Hiccoughs (Hiccups, Singultus)  1  2/24 (8.33%) 
Skin and subcutaneous tissue disorders   
Dermatology/Skin-Other  1  5/24 (20.83%) 
Dry Skin  1  2/24 (8.33%) 
Rash/Desquamation  1  4/24 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
This study did not reach its target accrual due to slow accrual. Small number of patients were analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Theresa Ryan, MD
Organization: New York University Cancer Institute
Phone: 212-731-5430
EMail: theresa.ryan@nyumc.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00463840     History of Changes
Other Study ID Numbers: 03-64
H11640 ( Other Identifier: NYU )
Sanofi-Aventis 0x 03-030 ( Other Identifier: Sanofi-Aventis )
First Submitted: April 18, 2007
First Posted: April 20, 2007
Results First Submitted: March 5, 2012
Results First Posted: May 1, 2012
Last Update Posted: December 5, 2017