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Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT00948935
Recruitment Status : Completed
First Posted : July 29, 2009
Results First Posted : June 18, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Biliary Cancer
Cholangiocarcinoma
Intervention Drug: Gemcitabine, Irinotecan, Panitumumab
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chemotherapy
Hide Arm/Group Description

Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

Period Title: Overall Study
Started 35
Completed 35
Not Completed 0
Arm/Group Title Chemotherapy
Hide Arm/Group Description

Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
  57.1%
>=65 years
15
  42.9%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 35 participants
62
(26 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
17
  48.6%
Male
18
  51.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
1.Primary Outcome
Title Progression Free Survival Rate at Five Months
Hide Description [Not Specified]
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy
Hide Arm/Group Description:

Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: percentage of participants
69
2.Secondary Outcome
Title Response Rate From Combination Chemotherapy
Hide Description [Not Specified]
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy
Hide Arm/Group Description:

Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
2
   5.7%
Partial Response
9
  25.7%
Stable Disease
15
  42.9%
Progressive Disease
2
   5.7%
Not Assessable
7
  20.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chemotherapy
Hide Arm/Group Description

Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

Gemcitabine, Irinotecan, Panitumumab: Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

All-Cause Mortality
Chemotherapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Chemotherapy
Affected / at Risk (%) # Events
Total   21/35 (60.00%)    
Cardiac disorders   
Cardiac Arrhythmia  1/35 (2.86%)  1
Gastrointestinal disorders   
Dehydration  5/35 (14.29%)  6
Diarrhea  2/35 (5.71%)  2
Free Air  1/35 (2.86%)  1
Obstruction, GI  3/35 (8.57%)  5
General disorders   
Fatigue  1/35 (2.86%)  1
Fever  4/35 (11.43%)  5
Pain  1/35 (2.86%)  2
Infections and infestations   
Abdomen NOS  1/35 (2.86%)  1
Febrile Neutropenia  1/35 (2.86%)  1
Neurological Meningitis  1/35 (2.86%)  1
Sepsis  1/35 (2.86%)  1
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e  1/35 (2.86%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils  1/35 (2.86%)  1
Infection with unknown ANC  1/35 (2.86%)  1
Metabolism and nutrition disorders   
Hyperbilirubinemia  1/35 (2.86%)  1
Hypercalcemia  1/35 (2.86%)  1
Hypomagnesemia  1/35 (2.86%)  1
Nervous system disorders   
Confusion  1/35 (2.86%)  1
Encephalopathy  1/35 (2.86%)  2
Syncope (fainting)  1/35 (2.86%)  2
Renal and urinary disorders   
Renal Failure  1/35 (2.86%)  1
Reproductive system and breast disorders   
chronic obstructive pulmonary disease  1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory Arrest  1/35 (2.86%)  1
Dyspnea  1/35 (2.86%)  1
Pleural Effusion  1/35 (2.86%)  1
Skin and subcutaneous tissue disorders   
Rash  1/35 (2.86%)  1
Vascular disorders   
Peripheral arterial ischemia  1/35 (2.86%)  2
Thrombosis/thombus/embolism  4/35 (11.43%)  8
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chemotherapy
Affected / at Risk (%) # Events
Total   35/35 (100.00%)    
Blood and lymphatic system disorders   
neutropenia  20/35 (57.14%)  90
edema  17/35 (48.57%)  42
dermal changes  1/35 (2.86%)  1
anemia  32/35 (91.43%)  173
Leukocytosis  23/35 (65.71%)  151
neutropenic fever  3/35 (8.57%)  3
thrombocytosis  1/35 (2.86%)  1
Cardiac disorders   
palpitations  4/35 (11.43%)  4
Pericardial effusion  1/35 (2.86%)  1
Ear and labyrinth disorders   
Ear Pain  1/35 (2.86%)  1
Eye disorders   
blurred vision  3/35 (8.57%)  3
dry eye  1/35 (2.86%)  1
floater  1/35 (2.86%)  2
scratched cornea  1/35 (2.86%)  1
Gastrointestinal disorders   
bloating  5/35 (14.29%)  5
abdominal cramping  1/35 (2.86%)  2
abdominal fullness  1/35 (2.86%)  1
abdominal pain  16/35 (45.71%)  18
anorexia  13/35 (37.14%)  17
ascites  4/35 (11.43%)  4
belching  1/35 (2.86%)  1
constipation  23/35 (65.71%)  33
decreased appetite  1/35 (2.86%)  1
dehydration  13/35 (37.14%)  17
diarrhea  25/35 (71.43%)  51
dry mouth  3/35 (8.57%)  4
Dysgeusia  1/35 (2.86%)  1
Dyspepsia  2/35 (5.71%)  2
dysphagia  1/35 (2.86%)  1
flatulance  5/35 (14.29%)  5
heartburn  4/35 (11.43%)  4
mouth sores  1/35 (2.86%)  1
mucositis  9/35 (25.71%)  16
nausea  25/35 (71.43%)  35
reflux  1/35 (2.86%)  2
small bowel obstruction  2/35 (5.71%)  4
taste alteration  5/35 (14.29%)  5
upset stomach  1/35 (2.86%)  1
vomiting  14/35 (40.00%)  24
General disorders   
infusion reaction  3/35 (8.57%)  3
Chills  4/35 (11.43%)  6
dizziness  12/35 (34.29%)  17
fatigue  26/35 (74.29%)  39
Fever  7/35 (20.00%)  11
flu-like symptoms  1/35 (2.86%)  1
aches  1/35 (2.86%)  1
night sweats  4/35 (11.43%)  4
chest pain  1/35 (2.86%)  2
rigors  1/35 (2.86%)  1
sweating  3/35 (8.57%)  4
Hepatobiliary disorders   
Hepatic Encephalopathy  1/35 (2.86%)  1
Hepatic pain  1/35 (2.86%)  2
Immune system disorders   
allergic rhinitis  1/35 (2.86%)  1
tape allergy  1/35 (2.86%)  1
cold (respiratory)  1/35 (2.86%)  1
rhinitis  2/35 (5.71%)  2
seasonal allergy  1/35 (2.86%)  1
Infections and infestations   
ascending cholangitis  1/35 (2.86%)  1
cellulitis  1/35 (2.86%)  1
conjuctivitis  3/35 (8.57%)  5
eye infection  2/35 (5.71%)  3
febrile neutropenia  3/35 (8.57%)  3
fungal infection  8/35 (22.86%)  9
skin infection  5/35 (14.29%)  6
sinus infection  1/35 (2.86%)  1
finger infection  1/35 (2.86%)  1
toe infection  1/35 (2.86%)  1
oral thrush  1/35 (2.86%)  1
occular infection  1/35 (2.86%)  1
paronychia  2/35 (5.71%)  5
pneumonia  1/35 (2.86%)  1
respiratory infection  1/35 (2.86%)  2
sepsis  3/35 (8.57%)  3
septic shock  1/35 (2.86%)  1
sinusitus  1/35 (2.86%)  1
thrush  4/35 (11.43%)  7
urinary tract infection  4/35 (11.43%)  5
yeast infection  1/35 (2.86%)  1
Injury, poisoning and procedural complications   
fall  1/35 (2.86%)  1
stent pain  1/35 (2.86%)  1
vessel injury  1/35 (2.86%)  1
Investigations   
lymphopenia  8/35 (22.86%)  79
Neutrophil count decreased  4/35 (11.43%)  6
Platelet count decreased  25/35 (71.43%)  81
Activated partial thromboplastin time prolonged  3/35 (8.57%)  9
weight loss  10/35 (28.57%)  13
Metabolism and nutrition disorders   
acidosis  1/35 (2.86%)  1
Hypoalbuminemia  28/35 (80.00%)  107
alkaline phosphatase (high)  22/35 (62.86%)  59
alkalosis  1/35 (2.86%)  1
Alanine Aminotransferase (high)  16/35 (45.71%)  35
amylase (high)  1/35 (2.86%)  1
Aspartate Aminotransferase (high)  24/35 (68.57%)  55
Metabolic Acidosis  11/35 (31.43%)  14
bilirubin (high)  17/35 (48.57%)  32
low calcium  28/35 (80.00%)  94
high calcium  2/35 (5.71%)  3
high creatinine  7/35 (20.00%)  8
electrolyte imbalance  1/35 (2.86%)  1
elevated LTF  1/35 (2.86%)  1
hypergylcemia  27/35 (77.14%)  150
hypoglymcemia  12/35 (34.29%)  30
hypokalemia  1/35 (2.86%)  2
Hypomagnesemia  22/35 (62.86%)  54
loss of appetite  3/35 (8.57%)  3
hypermagnesemia  2/35 (5.71%)  3
Hypophosphatemia  8/35 (22.86%)  20
Hypokalemia  18/35 (51.43%)  58
Hypernatremia  3/35 (8.57%)  3
Hyponatremia  23/35 (65.71%)  66
Hypertriglyceridemia  1/35 (2.86%)  1
Hyperkalemia  4/35 (11.43%)  7
Musculoskeletal and connective tissue disorders   
back pain  12/35 (34.29%)  22
Body Aches  1/35 (2.86%)  1
Foot pain  1/35 (2.86%)  1
fracture  2/35 (5.71%)  2
carpal tunel  1/35 (2.86%)  1
Hyperesthesia  1/35 (2.86%)  1
leg cramps  1/35 (2.86%)  1
muscle cramping  2/35 (5.71%)  2
buttock pain  1/35 (2.86%)  1
Joint Pain  1/35 (2.86%)  1
shoulder pain  2/35 (5.71%)  3
forearm pain  1/35 (2.86%)  2
Upper Quadrant Pain  4/35 (11.43%)  4
Scapula pain  1/35 (2.86%)  1
Nervous system disorders   
cerebro-vascular ischemia  1/35 (2.86%)  1
hand tremors  1/35 (2.86%)  1
headache  11/35 (31.43%)  12
light headedness  1/35 (2.86%)  1
numbness  1/35 (2.86%)  1
Solar Plexis Pain  1/35 (2.86%)  2
sinus headache  1/35 (2.86%)  1
somnolence  1/35 (2.86%)  1
syncope  2/35 (5.71%)  2
Psychiatric disorders   
anxiety  9/35 (25.71%)  10
confusion  3/35 (8.57%)  3
dementia  1/35 (2.86%)  1
depression  8/35 (22.86%)  14
insomnia  12/35 (34.29%)  12
Renal and urinary disorders   
acute renal failure  1/35 (2.86%)  1
hematuria  1/35 (2.86%)  1
kidney stone  1/35 (2.86%)  1
rectal bleeding  3/35 (8.57%)  3
rectal fissure  1/35 (2.86%)  1
renal failure  1/35 (2.86%)  1
Reproductive system and breast disorders   
erectile dysfunction  2/35 (5.71%)  3
Pleural effusion  1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders   
atelectasis  1/35 (2.86%)  1
congestion  2/35 (5.71%)  2
cough  13/35 (37.14%)  17
dry cough  1/35 (2.86%)  2
dyspnea  13/35 (37.14%)  18
epistaxis  4/35 (11.43%)  5
hiccups  2/35 (5.71%)  3
hoarseness  1/35 (2.86%)  1
hypoxia  1/35 (2.86%)  1
shortness of breath  3/35 (8.57%)  4
sore throat  4/35 (11.43%)  4
upper respiratory congestion  1/35 (2.86%)  1
Skin and subcutaneous tissue disorders   
acne-form  2/35 (5.71%)  2
alopecia  19/35 (54.29%)  20
cheliosis  3/35 (8.57%)  3
contact dermatitis  1/35 (2.86%)  1
dry skin  10/35 (28.57%)  15
exostosis  1/35 (2.86%)  1
Palmar-plantar erythrodysesthesia syndrome  1/35 (2.86%)  1
herituism  1/35 (2.86%)  1
hypertochosis  1/35 (2.86%)  1
itching  1/35 (2.86%)  1
IV infiltration  1/35 (2.86%)  1
karatoses  1/35 (2.86%)  2
leg ulceration  1/35 (2.86%)  1
hypertrichosis  1/35 (2.86%)  1
periorbital hair changes  2/35 (5.71%)  2
xerosis back  1/35 (2.86%)  1
poison ivy  1/35 (2.86%)  2
Pruritis  1/35 (2.86%)  2
rash  33/35 (94.29%)  135
trichomegaly  4/35 (11.43%)  4
Vascular disorders   
acute arterial occulsion LLE  1/35 (2.86%)  1
hemorrhoids  1/35 (2.86%)  1
Flush  1/35 (2.86%)  1
hot flashes  1/35 (2.86%)  1
hypertension  5/35 (14.29%)  5
Pulmonary Embolism  4/35 (11.43%)  5
sinus tachcardia  1/35 (2.86%)  1
deep vein thrombosis  2/35 (5.71%)  2
thrombosis  2/35 (5.71%)  2
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: Bruce Giantonio
Organization: Abramson Cancer Center
Phone: (215) 615-5858
EMail: bruce.giantonio@uphs.upenn.edu
Layout table for additonal information
Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00948935     History of Changes
Other Study ID Numbers: UPCC 06208
First Submitted: May 15, 2009
First Posted: July 29, 2009
Results First Submitted: April 16, 2019
Results First Posted: June 18, 2019
Last Update Posted: June 26, 2019