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Trial record 43 of 2832 for:    Pancreatic Cancer

BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study (278)

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ClinicalTrials.gov Identifier: NCT01744353
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : April 11, 2016
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
Lifespan
Rhode Island Hospital
Memorial Hospital of Rhode Island
Information provided by (Responsible Party):
howard safran, Brown University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Pancreatic Cancer
Interventions Drug: Dose level 1
Drug: Dose level 2/MTD
Drug: Dose level 3
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental: Dose Level 1 Experimental: Dose Level 2/ MTD Experimental: Dose Level 3
Hide Arm/Group Description Abraxane 125 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion Abraxane 150 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion Abraxane 175 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
Period Title: Overall Study
Started 6 26 3
Completed 6 26 3
Not Completed 0 0 0
Arm/Group Title Experimental: Dose Level 1 Experimental: Dose Level 2/ MTD Experimental: Dose Level 3 Total
Hide Arm/Group Description

Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion

Other Names:

5-FU infusion, leuocovorin, oxaliplatin, Abraxane

Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion

Other Names:

5-FU infusion, leuocovorin, oxaliplatin, Abraxane

Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion

Other Names:

5-FU infusion, leuocovorin, oxaliplatin, Abraxane

Total of all reporting groups
Overall Number of Baseline Participants 6 26 3 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 26 participants 3 participants 35 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  50.0%
15
  57.7%
2
  66.7%
20
  57.1%
>=65 years
3
  50.0%
11
  42.3%
1
  33.3%
15
  42.9%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 26 participants 3 participants 35 participants
58.83
(35 to 70)
63.38
(41 to 82)
63.33
(58 to 67)
61.85
(35 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 26 participants 3 participants 35 participants
Female
5
  83.3%
10
  38.5%
1
  33.3%
16
  45.7%
Male
1
  16.7%
16
  61.5%
2
  66.7%
19
  54.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 26 participants 3 participants 35 participants
6 26 3 35
1.Primary Outcome
Title Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer.
Hide Description MTD (Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion) was defined by protocol documented and predefined DLT's in 3 dose levels.
Time Frame For up to 30 days post completing drug, an expected average of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental: Dose Level 1 Experimental: Dose Level 2/ MTD Experimental: Dose Level 3
Hide Arm/Group Description:

Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion

Other Names:

5-FU infusion, leuocovorin, oxaliplatin, Abraxane

Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion

Other Names:

5-FU infusion, leuocovorin, oxaliplatin, Abraxane

Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion

Other Names:

5-FU infusion, leuocovorin, oxaliplatin, Abraxan

Overall Number of Participants Analyzed 6 26 3
Measure Type: Number
Unit of Measure: participants
1 1 2
2.Secondary Outcome
Title Response Rate (if Patient's Tumor(s)Are Progressing or Being Controlled) Following Treatment With FOLFOX-A for Patients With Newly Diagnosed, Advanced Pancreatic Cancer.
Hide Description Data below summarizes number of patients who experienced partial response. Partial response evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 Response Criteria Partial Response (PR) At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters
Time Frame pre-drug until disease progression, whichever comes first, for an expected average of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental: Dose Level 1 Experimental: Dose Level 2/ MTD Experimental: Dose Level 3
Hide Arm/Group Description:

Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion

Other Names:

5-FU infusion, leuocovorin, oxaliplatin, Abraxane

Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion

Other Names:

5-FU infusion, leuocovorin, oxaliplatin, Abraxane

Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion

Other Names:

5-FU infusion, leuocovorin, oxaliplatin, Abraxan

Overall Number of Participants Analyzed 6 26 3
Measure Type: Number
Unit of Measure: participants
3 17 1
Time Frame [Not Specified]
Adverse Event Reporting Description Our preference is to keep as documented as it shows all toxicities experienced by this combo regimen by all patients.
 
Arm/Group Title FOLFOX- A
Hide Arm/Group Description

FOLFOX-A Dose levels -1, 1, 2, 3: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue until level 3 provided that the MTD has not been reached. If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If dose level 1 is not tolerable then dose level -1 will be investigated. Once the MTD is found, the Principal Investigator will determine which dose should be assessed futher and an additional 10 patients will be treated.

FOLFOX-A: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue un

All-Cause Mortality
FOLFOX- A
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
FOLFOX- A
Affected / at Risk (%) # Events
Total   19/35 (54.29%)    
Investigations   
AKI   2/35 (5.71%)  2
anemia/HGB   2/35 (5.71%)  2
Bili   2/35 (5.71%)  2
confusion   2/35 (5.71%)  2
constipation   1/35 (2.86%)  1
Creatinine   2/35 (5.71%)  2
diarrhea   2/35 (5.71%)  2
Dizziness   1/35 (2.86%)  1
dyspnea   1/35 (2.86%)  1
fatigue   1/35 (2.86%)  1
fever   3/35 (8.57%)  3
Gout/pseuso-gout   1/35 (2.86%)  1
hypokalemia   1/35 (2.86%)  1
Hypotension   3/35 (8.57%)  3
hypoxia   1/35 (2.86%)  1
Infection   7/35 (20.00%)  7
mucositits   1/35 (2.86%)  1
muscle weakness general/M&A/malaise/generalized body aches   2/35 (5.71%)  2
Nausea   2/35 (5.71%)  2
Pain abdomen   2/35 (5.71%)  2
pain extremity (knee,hip,leg,pelvis,arm,neck,shoulder,wrist,rib,elbow, back, toe)   3/35 (8.57%)  3
Pleural effusion   1/35 (2.86%)  1
pre-syncope   1/35 (2.86%)  1
rotator cuff tear   1/35 (2.86%)  1
TIA   1/35 (2.86%)  1
Thromboemblic event (pulm embol)/DVT   2/35 (5.71%)  2
vasovagal   1/35 (2.86%)  1
vomiting   1/35 (2.86%)  1
wbc   1/35 (2.86%)  1
Colonic Obstruction   1/35 (2.86%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FOLFOX- A
Affected / at Risk (%) # Events
Total   35/35 (100.00%)    
Investigations   
abdominal distention   1/35 (2.86%)  1
Allergic reaction to Oxali and overall allergic reaction   4/35 (11.43%)  4
alk phos   7/35 (20.00%)  7
alopecia   4/35 (11.43%)  4
ALT   16/35 (45.71%)  16
ANC   11/35 (31.43%)  11
anemia/HGB   21/35 (60.00%)  21
anorexia   7/35 (20.00%)  7
anxiety   3/35 (8.57%)  3
AST   17/35 (48.57%)  17
blurry vision   1/35 (2.86%)  1
BUN   2/35 (5.71%)  2
Calcium/CA   5/35 (14.29%)  5
Chills/rigors   3/35 (8.57%)  3
confusion   2/35 (5.71%)  2
constipation   14/35 (40.00%)  14
Cough   6/35 (17.14%)  6
Creatinine   4/35 (11.43%)  4
dehydration   3/35 (8.57%)  3
Depression   3/35 (8.57%)  3
diarrhea   15/35 (42.86%)  15
Dizziness   3/35 (8.57%)  3
dysgeusia (taste)   3/35 (8.57%)  3
dysuria   1/35 (2.86%)  1
dyspnea   1/35 (2.86%)  1
edema   9/35 (25.71%)  9
eye disorder- other   1/35 (2.86%)  1
fatigue   23/35 (65.71%)  23
fever   5/35 (14.29%)  5
cramping extermeties   2/35 (5.71%)  2
flatulanence   1/35 (2.86%)  1
Flushing   2/35 (5.71%)  2
Folliculitis- scalp   1/35 (2.86%)  1
GERD   1/35 (2.86%)  1
Gout/pseuso-gout   1/35 (2.86%)  1
Headache   3/35 (8.57%)  3
hearing impairment   1/35 (2.86%)  1
heartburn   2/35 (5.71%)  2
hemorrhoids   1/35 (2.86%)  1
Hiccups   1/35 (2.86%)  1
hypoalbum   4/35 (11.43%)  4
hypokalemia   15/35 (42.86%)  15
Hypotension   2/35 (5.71%)  2
Infection   7/35 (20.00%)  7
insomnia   2/35 (5.71%)  2
itchiness (head/neck)   1/35 (2.86%)  1
LDH   1/35 (2.86%)  1
Lymph   8/35 (22.86%)  8
mg   1/35 (2.86%)  1
memory impairment   1/35 (2.86%)  1
mucositits   6/35 (17.14%)  6
muscle weakness general/M&A/malaise/generalized body aches   6/35 (17.14%)  6
myositis   1/35 (2.86%)  1
Nausea   24/35 (68.57%)  24
neuropathy   25/35 (71.43%)  25
Phos   1/35 (2.86%)  1
arthritis   1/35 (2.86%)  1
Pain abdomen   6/35 (17.14%)  6
Pain bone   4/35 (11.43%)  4
Pain chest   3/35 (8.57%)  3
pain epigastric   1/35 (2.86%)  1
pain extremity (knee,hip,leg,pelvis,arm,neck,shoulder,wrist,rib,elbow, back, toe)   9/35 (25.71%)  9
post nasal drip/nasal congestion   2/35 (5.71%)  2
Renal Calculi(kidney stones)   1/35 (2.86%)  1
skin laceration (L finger)   1/35 (2.86%)  1
Skin- dry   2/35 (5.71%)  2
sodium/NA   15/35 (42.86%)  15
spasticity throat   1/35 (2.86%)  1
thrombocytopenia   18/35 (51.43%)  18
Thromboemblic event (pulm embol)/DVT   4/35 (11.43%)  4
voice alteration(hoarsness)   1/35 (2.86%)  1
vomiting   5/35 (14.29%)  5
wbc   13/35 (37.14%)  13
weight loss   15/35 (42.86%)  15
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Helena Lau
Organization: Brown Oncology Research Group
Phone: 4018633000
Responsible Party: howard safran, Brown University
ClinicalTrials.gov Identifier: NCT01744353     History of Changes
Other Study ID Numbers: BrUOG 278
First Submitted: November 26, 2012
First Posted: December 6, 2012
Results First Submitted: May 6, 2015
Results First Posted: April 11, 2016
Last Update Posted: April 24, 2019