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

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT00948935
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arm: 1
• Actual Duration (Months): 65.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer.

Condition or Disease	Intervention/Treatment	Phase
Biliary Cancer; Cholangiocarcinoma	Drug: Gemcitabine, Irinotecan, Panitumumab	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Combination of Gemcitabine (Fixed Dose-rate Infusion, FDR), Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma
• Actual Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 26, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chemotherapy 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.	Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival Rate at Five Months [5 months]

Secondary Outcome Measures

1. Response Rate From Combination Chemotherapy [5 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• histologically or cytologically confirmed local advanced unresectable/metastatic adenocarcinoma of biliary tract

• measurable disease

• available tumor tissue for investigational immunohistochemical evaluations

• ECOG PS 0-2

• No prior chemotherapy, biologic therapy or radiation therapy

• Age Eighteen and older

• Lab values per protocol

Exclusion Criteria:

• Life expectancy less than three months

• Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs less than four weeks prior to enrollment

• Prior therapy, which affects or targets the EGF pathway

• Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer

• Recovery from major surgery within three weeks of the start of study treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center at University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Bruce Giantonia, MD, Abramson CC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00948935
• Other Study ID Numbers: UPCC 06208
• First Posted: Jul 29, 2009
• Last Update Posted: Mar 11, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Abramson Cancer Center of the University of Pennsylvania: Biliary Cancer; Cholangiocarcinoma; Panitumumab
• Additional relevant MeSH terms: Adenocarcinoma; Cholangiocarcinoma; Gemcitabine; Irinotecan; Panitumumab

Study Results

Participant Flow

Arm/Group Title	Chemotherapy
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

Baseline Characteristics

Arm/Group Title	Chemotherapy
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 Participants	35
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 57.1%
>=65 years	15 42.9%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	62
Sex: Female, Male (Count of Participants)
Female	17 48.6%
Male	18 51.4%
Region of Enrollment (participants) [Number]
United States	35 100%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival Rate at Five Months
Time Frame	5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chemotherapy
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.
Measure Participants	35
Number [percentage of participants]	69 197.1%

2. Secondary Outcome

Title	Response Rate From Combination Chemotherapy
Time Frame	5 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Chemotherapy
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.
Measure Participants	35
Complete Response	2 5.7%
Partial Response	9 25.7%
Stable Disease	15 42.9%
Progressive Disease	2 5.7%
Not Assessable	7 20%

Adverse Events

Arm/Group Title	Chemotherapy
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Chemotherapy
	Affected / at Risk (%)	# Events
Total	21/35 (60%)
Cardiac disorders
Cardiac Arrhythmia	1/35 (2.9%)	1
Gastrointestinal disorders
Dehydration	5/35 (14.3%)	6
Diarrhea	2/35 (5.7%)	2
Free Air	1/35 (2.9%)	1
Obstruction, GI	3/35 (8.6%)	5
General disorders
Fatigue	1/35 (2.9%)	1
Fever	4/35 (11.4%)	5
Pain	1/35 (2.9%)	2
Infections and infestations
Abdomen NOS	1/35 (2.9%)	1
Febrile Neutropenia	1/35 (2.9%)	1
Neurological Meningitis	1/35 (2.9%)	1
Sepsis	1/35 (2.9%)	1
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e	1/35 (2.9%)	1
Infection with normal ANC or Grade 1 or 2 neutrophils	1/35 (2.9%)	1
Infection with unknown ANC	1/35 (2.9%)	1
Metabolism and nutrition disorders
Hyperbilirubinemia	1/35 (2.9%)	1
Hypercalcemia	1/35 (2.9%)	1
Hypomagnesemia	1/35 (2.9%)	1
Nervous system disorders
Confusion	1/35 (2.9%)	1
Encephalopathy	1/35 (2.9%)	2
Syncope (fainting)	1/35 (2.9%)	2
Renal and urinary disorders
Renal Failure	1/35 (2.9%)	1
Reproductive system and breast disorders
chronic obstructive pulmonary disease	1/35 (2.9%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest	1/35 (2.9%)	1
Dyspnea	1/35 (2.9%)	1
Pleural Effusion	1/35 (2.9%)	1
Skin and subcutaneous tissue disorders
Rash	1/35 (2.9%)	1
Vascular disorders
Peripheral arterial ischemia	1/35 (2.9%)	2
Thrombosis/thombus/embolism	4/35 (11.4%)	8
Other (Not Including Serious) Adverse Events
	Chemotherapy
	Affected / at Risk (%)	# Events
Total	35/35 (100%)
Blood and lymphatic system disorders
neutropenia	20/35 (57.1%)	90
edema	17/35 (48.6%)	42
dermal changes	1/35 (2.9%)	1
anemia	32/35 (91.4%)	173
Leukocytosis	23/35 (65.7%)	151
neutropenic fever	3/35 (8.6%)	3
thrombocytosis	1/35 (2.9%)	1
Cardiac disorders
palpitations	4/35 (11.4%)	4
Pericardial effusion	1/35 (2.9%)	1
Ear and labyrinth disorders
Ear Pain	1/35 (2.9%)	1
Eye disorders
blurred vision	3/35 (8.6%)	3
dry eye	1/35 (2.9%)	1
floater	1/35 (2.9%)	2
scratched cornea	1/35 (2.9%)	1
Gastrointestinal disorders
bloating	5/35 (14.3%)	5
abdominal cramping	1/35 (2.9%)	2
abdominal fullness	1/35 (2.9%)	1
abdominal pain	16/35 (45.7%)	18
anorexia	13/35 (37.1%)	17
ascites	4/35 (11.4%)	4
belching	1/35 (2.9%)	1
constipation	23/35 (65.7%)	33
decreased appetite	1/35 (2.9%)	1
dehydration	13/35 (37.1%)	17
diarrhea	25/35 (71.4%)	51
dry mouth	3/35 (8.6%)	4
Dysgeusia	1/35 (2.9%)	1
Dyspepsia	2/35 (5.7%)	2
dysphagia	1/35 (2.9%)	1
flatulance	5/35 (14.3%)	5
heartburn	4/35 (11.4%)	4
mouth sores	1/35 (2.9%)	1
mucositis	9/35 (25.7%)	16
nausea	25/35 (71.4%)	35
reflux	1/35 (2.9%)	2
small bowel obstruction	2/35 (5.7%)	4
taste alteration	5/35 (14.3%)	5
upset stomach	1/35 (2.9%)	1
vomiting	14/35 (40%)	24
General disorders
infusion reaction	3/35 (8.6%)	3
Chills	4/35 (11.4%)	6
dizziness	12/35 (34.3%)	17
fatigue	26/35 (74.3%)	39
Fever	7/35 (20%)	11
flu-like symptoms	1/35 (2.9%)	1
aches	1/35 (2.9%)	1
night sweats	4/35 (11.4%)	4
chest pain	1/35 (2.9%)	2
rigors	1/35 (2.9%)	1
sweating	3/35 (8.6%)	4
Hepatobiliary disorders
Hepatic Encephalopathy	1/35 (2.9%)	1
Hepatic pain	1/35 (2.9%)	2
Immune system disorders
allergic rhinitis	1/35 (2.9%)	1
tape allergy	1/35 (2.9%)	1
cold (respiratory)	1/35 (2.9%)	1
rhinitis	2/35 (5.7%)	2
seasonal allergy	1/35 (2.9%)	1
Infections and infestations
ascending cholangitis	1/35 (2.9%)	1
cellulitis	1/35 (2.9%)	1
conjuctivitis	3/35 (8.6%)	5
eye infection	2/35 (5.7%)	3
febrile neutropenia	3/35 (8.6%)	3
fungal infection	8/35 (22.9%)	9
skin infection	5/35 (14.3%)	6
sinus infection	1/35 (2.9%)	1
finger infection	1/35 (2.9%)	1
toe infection	1/35 (2.9%)	1
oral thrush	1/35 (2.9%)	1
occular infection	1/35 (2.9%)	1
paronychia	2/35 (5.7%)	5
pneumonia	1/35 (2.9%)	1
respiratory infection	1/35 (2.9%)	2
sepsis	3/35 (8.6%)	3
septic shock	1/35 (2.9%)	1
sinusitus	1/35 (2.9%)	1
thrush	4/35 (11.4%)	7
urinary tract infection	4/35 (11.4%)	5
yeast infection	1/35 (2.9%)	1
Injury, poisoning and procedural complications
fall	1/35 (2.9%)	1
stent pain	1/35 (2.9%)	1
vessel injury	1/35 (2.9%)	1
Investigations
lymphopenia	8/35 (22.9%)	79
Neutrophil count decreased	4/35 (11.4%)	6
Platelet count decreased	25/35 (71.4%)	81
Activated partial thromboplastin time prolonged	3/35 (8.6%)	9
weight loss	10/35 (28.6%)	13
Metabolism and nutrition disorders
acidosis	1/35 (2.9%)	1
Hypoalbuminemia	28/35 (80%)	107
alkaline phosphatase (high)	22/35 (62.9%)	59
alkalosis	1/35 (2.9%)	1
Alanine Aminotransferase (high)	16/35 (45.7%)	35
amylase (high)	1/35 (2.9%)	1
Aspartate Aminotransferase (high)	24/35 (68.6%)	55
Metabolic Acidosis	11/35 (31.4%)	14
bilirubin (high)	17/35 (48.6%)	32
low calcium	28/35 (80%)	94
high calcium	2/35 (5.7%)	3
high creatinine	7/35 (20%)	8
electrolyte imbalance	1/35 (2.9%)	1
elevated LTF	1/35 (2.9%)	1
hypergylcemia	27/35 (77.1%)	150
hypoglymcemia	12/35 (34.3%)	30
hypokalemia	1/35 (2.9%)	2
Hypomagnesemia	22/35 (62.9%)	54
loss of appetite	3/35 (8.6%)	3
hypermagnesemia	2/35 (5.7%)	3
Hypophosphatemia	8/35 (22.9%)	20
Hypokalemia	18/35 (51.4%)	58
Hypernatremia	3/35 (8.6%)	3
Hyponatremia	23/35 (65.7%)	66
Hypertriglyceridemia	1/35 (2.9%)	1
Hyperkalemia	4/35 (11.4%)	7
Musculoskeletal and connective tissue disorders
back pain	12/35 (34.3%)	22
Body Aches	1/35 (2.9%)	1
Foot pain	1/35 (2.9%)	1
fracture	2/35 (5.7%)	2
carpal tunel	1/35 (2.9%)	1
Hyperesthesia	1/35 (2.9%)	1
leg cramps	1/35 (2.9%)	1
muscle cramping	2/35 (5.7%)	2
buttock pain	1/35 (2.9%)	1
Joint Pain	1/35 (2.9%)	1
shoulder pain	2/35 (5.7%)	3
forearm pain	1/35 (2.9%)	2
Upper Quadrant Pain	4/35 (11.4%)	4
Scapula pain	1/35 (2.9%)	1
Nervous system disorders
cerebro-vascular ischemia	1/35 (2.9%)	1
hand tremors	1/35 (2.9%)	1
headache	11/35 (31.4%)	12
light headedness	1/35 (2.9%)	1
numbness	1/35 (2.9%)	1
Solar Plexis Pain	1/35 (2.9%)	2
sinus headache	1/35 (2.9%)	1
somnolence	1/35 (2.9%)	1
syncope	2/35 (5.7%)	2
Psychiatric disorders
anxiety	9/35 (25.7%)	10
confusion	3/35 (8.6%)	3
dementia	1/35 (2.9%)	1
depression	8/35 (22.9%)	14
insomnia	12/35 (34.3%)	12
Renal and urinary disorders
acute renal failure	1/35 (2.9%)	1
hematuria	1/35 (2.9%)	1
kidney stone	1/35 (2.9%)	1
rectal bleeding	3/35 (8.6%)	3
rectal fissure	1/35 (2.9%)	1
renal failure	1/35 (2.9%)	1
Reproductive system and breast disorders
erectile dysfunction	2/35 (5.7%)	3
Pleural effusion	1/35 (2.9%)	1
Respiratory, thoracic and mediastinal disorders
atelectasis	1/35 (2.9%)	1
congestion	2/35 (5.7%)	2
cough	13/35 (37.1%)	17
dry cough	1/35 (2.9%)	2
dyspnea	13/35 (37.1%)	18
epistaxis	4/35 (11.4%)	5
hiccups	2/35 (5.7%)	3
hoarseness	1/35 (2.9%)	1
hypoxia	1/35 (2.9%)	1
shortness of breath	3/35 (8.6%)	4
sore throat	4/35 (11.4%)	4
upper respiratory congestion	1/35 (2.9%)	1
Skin and subcutaneous tissue disorders
acne-form	2/35 (5.7%)	2
alopecia	19/35 (54.3%)	20
cheliosis	3/35 (8.6%)	3
contact dermatitis	1/35 (2.9%)	1
dry skin	10/35 (28.6%)	15
exostosis	1/35 (2.9%)	1
Palmar-plantar erythrodysesthesia syndrome	1/35 (2.9%)	1
herituism	1/35 (2.9%)	1
hypertochosis	1/35 (2.9%)	1
itching	1/35 (2.9%)	1
IV infiltration	1/35 (2.9%)	1
karatoses	1/35 (2.9%)	2
leg ulceration	1/35 (2.9%)	1
hypertrichosis	1/35 (2.9%)	1
periorbital hair changes	2/35 (5.7%)	2
xerosis back	1/35 (2.9%)	1
poison ivy	1/35 (2.9%)	2
Pruritis	1/35 (2.9%)	2
rash	33/35 (94.3%)	135
trichomegaly	4/35 (11.4%)	4
Vascular disorders
acute arterial occulsion LLE	1/35 (2.9%)	1
hemorrhoids	1/35 (2.9%)	1
Flush	1/35 (2.9%)	1
hot flashes	1/35 (2.9%)	1
hypertension	5/35 (14.3%)	5
Pulmonary Embolism	4/35 (11.4%)	5
sinus tachcardia	1/35 (2.9%)	1
deep vein thrombosis	2/35 (5.7%)	2
thrombosis	2/35 (5.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.