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Sorafenib Tosylate and Erlotinib Hydrochloride in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gallbladder Cancer or Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT01093222
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : January 29, 2014
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Extrahepatic Bile Duct Adenocarcinoma
Gallbladder Adenocarcinoma
Gallbladder Adenocarcinoma With Squamous Metaplasia
Hilar Cholangiocarcinoma
Recurrent Extrahepatic Bile Duct Carcinoma
Recurrent Gallbladder Carcinoma
Undifferentiated Gallbladder Carcinoma
Unresectable Extrahepatic Bile Duct Carcinoma
Unresectable Gallbladder Carcinoma
Interventions Drug: Erlotinib Hydrochloride
Drug: Sorafenib Tosylate
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sorafenib and Erlotinib
Hide Arm/Group Description Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 40
Eligible and Began Protocol Therapy 34
Completed 0
Not Completed 40
Reason Not Completed
Ineligible             6
Adverse Event             7
Progression/relapse             24
Death             2
Not protocol specified             1
Arm/Group Title Sorafenib and Erlotinib
Hide Arm/Group Description Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
Eligible patients who began protocol therapy
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants
63
(49 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
21
  61.8%
Male
13
  38.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Hispanic or Latino
4
  11.8%
Not Hispanic or Latino
30
  88.2%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   8.8%
White
28
  82.4%
More than one race
0
   0.0%
Unknown or Not Reported
2
   5.9%
Zubrod Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
0 19
1 15
[1]
Measure Description: Zubrod Performance Status Scale: 0 - Fully active, able to carry on all pre-disease performance without restriction; 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light sedentary nature; 2 - Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours; 3 - Capable of limited self-care, confined to bed or chair more than 50% of waking hours; 4 - Completely disabled, cannot carry on any self-care, totally confined to bed or chair
Chemotherapy, multiple agents  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
Yes 1
No 33
Prior Surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
Yes 14
No 20
Current Status of Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
Distant Metastatic 28
Locally Advanced 6
Primary Cancer  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
Cholangiocarcinoma 20
Gallbladder 14
Prior Radiation Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
Yes 0
No 34
Setting of Prior Chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants
Adjuvant 1
Neoadjuvant 0
None 33
1.Primary Outcome
Title Progression-free Survival
Hide Description From date of registration to date of first documentation of progression or symptomatic deterioration (as defined in protocol), or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who began protocol therapy
Arm/Group Title Sorafenib and Erlotinib
Hide Arm/Group Description:
Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: months
2
(2 to 3)
2.Secondary Outcome
Title Overall Survival
Hide Description From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who began protocol therapy
Arm/Group Title Sorafenib and Erlotinib
Hide Arm/Group Description:
Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: months
6
(3 to 8)
3.Secondary Outcome
Title Objective Response
Hide Description Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions and no disease related symptoms. Partial response (PR) is a greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who began protocol therapy
Arm/Group Title Sorafenib and Erlotinib
Hide Arm/Group Description:
Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6
(1 to 20)
4.Secondary Outcome
Title Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hide Description Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE v4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Arm/Group Title Sorafenib and Erlotinib
Hide Arm/Group Description:
Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: Participants
Abdominal pain 1
Alanine aminotransferase increased 4
Alkaline phosphatase increased 3
Allergic reaction 1
Aspartate aminotransferase increased 3
Blood bilirubin increased 2
Death NOS 1
Dehydration 1
Diarrhea 3
Erythema multiforme 1
Fatigue 1
Gastric perforation 1
Hepatic failure 1
Hepatic infection 1
Hepatic necrosis 1
Hypertension 5
Hypoalbuminemia 1
Hypokalemia 2
Hypophosphatemia 3
Hypoxia 1
Lymphocyte count decreased 1
Mucositis oral 1
Nausea 1
Pain 1
Palmar-plantar erythrodysesthesia syndrome 2
Platelet count decreased 1
Rash acneiform 1
Rash maculo-papular 1
Thromboembolic event 1
Time Frame Up to 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sorafenib and Erlotinib
Hide Arm/Group Description Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Sorafenib and Erlotinib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sorafenib and Erlotinib
Affected / at Risk (%)
Total   17/34 (50.00%) 
Cardiac disorders   
Cardiac arrest  1  1/34 (2.94%) 
Gastrointestinal disorders   
Abdominal pain  1  4/34 (11.76%) 
Ascites  1  1/34 (2.94%) 
Diarrhea  1  1/34 (2.94%) 
Duodenal ulcer  1  1/34 (2.94%) 
Gastric perforation  1  1/34 (2.94%) 
Gastritis  1  1/34 (2.94%) 
Gastrointestinal disorders - Other, specify  1  1/34 (2.94%) 
Nausea  1  3/34 (8.82%) 
Small intestinal obstruction  1  1/34 (2.94%) 
Vomiting  1  2/34 (5.88%) 
General disorders   
Death NOS  1  6/34 (17.65%) 
Multi-organ failure  1  1/34 (2.94%) 
Hepatobiliary disorders   
Bile duct stenosis  1  1/34 (2.94%) 
Gallbladder obstruction  1  1/34 (2.94%) 
Hepatic necrosis  1  1/34 (2.94%) 
Hepatobiliary disorders - Other, specify  1  1/34 (2.94%) 
Immune system disorders   
Allergic reaction  1  1/34 (2.94%) 
Infections and infestations   
Device related infection  1  1/34 (2.94%) 
Hepatic infection  1  1/34 (2.94%) 
Lung infection  1  1/34 (2.94%) 
Sepsis  1  3/34 (8.82%) 
Investigations   
Alanine aminotransferase increased  1  1/34 (2.94%) 
Alkaline phosphatase increased  1  2/34 (5.88%) 
Aspartate aminotransferase increased  1  2/34 (5.88%) 
Blood bilirubin increased  1  4/34 (11.76%) 
Metabolism and nutrition disorders   
Dehydration  1  2/34 (5.88%) 
Hypoalbuminemia  1  2/34 (5.88%) 
Musculoskeletal and connective tissue disorders   
Generalized muscle weakness  1  1/34 (2.94%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified - Other  1  1/34 (2.94%) 
Nervous system disorders   
Dizziness  1  1/34 (2.94%) 
Lethargy  1  1/34 (2.94%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/34 (2.94%) 
Skin and subcutaneous tissue disorders   
Erythema multiforme  1  1/34 (2.94%) 
Vascular disorders   
Hypertension  1  1/34 (2.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sorafenib and Erlotinib
Affected / at Risk (%)
Total   33/34 (97.06%) 
Blood and lymphatic system disorders   
Anemia  1  11/34 (32.35%) 
Leukocytosis  1  2/34 (5.88%) 
Eye disorders   
Conjunctivitis  1  2/34 (5.88%) 
Dry eye  1  2/34 (5.88%) 
Gastrointestinal disorders   
Abdominal distension  1  3/34 (8.82%) 
Abdominal pain  1  13/34 (38.24%) 
Constipation  1  15/34 (44.12%) 
Diarrhea  1  20/34 (58.82%) 
Dry mouth  1  4/34 (11.76%) 
Dyspepsia  1  6/34 (17.65%) 
Flatulence  1  3/34 (8.82%) 
Mucositis oral  1  10/34 (29.41%) 
Nausea  1  17/34 (50.00%) 
Oral pain  1  3/34 (8.82%) 
Rectal hemorrhage  1  3/34 (8.82%) 
Stomach pain  1  2/34 (5.88%) 
Vomiting  1  6/34 (17.65%) 
General disorders   
Chills  1  2/34 (5.88%) 
Edema limbs  1  6/34 (17.65%) 
Fatigue  1  17/34 (50.00%) 
Fever  1  2/34 (5.88%) 
Flu like symptoms  1  2/34 (5.88%) 
Pain  1  6/34 (17.65%) 
Infections and infestations   
Urinary tract infection  1  3/34 (8.82%) 
Investigations   
Activated partial thromboplastin time prolonged  1  2/34 (5.88%) 
Alanine aminotransferase increased  1  18/34 (52.94%) 
Alkaline phosphatase increased  1  17/34 (50.00%) 
Aspartate aminotransferase increased  1  22/34 (64.71%) 
Blood bilirubin increased  1  12/34 (35.29%) 
Creatinine increased  1  2/34 (5.88%) 
INR increased  1  2/34 (5.88%) 
Lymphocyte count decreased  1  6/34 (17.65%) 
Platelet count decreased  1  10/34 (29.41%) 
Weight loss  1  9/34 (26.47%) 
Metabolism and nutrition disorders   
Anorexia  1  10/34 (29.41%) 
Dehydration  1  2/34 (5.88%) 
Hyperglycemia  1  12/34 (35.29%) 
Hypoalbuminemia  1  10/34 (29.41%) 
Hypocalcemia  1  6/34 (17.65%) 
Hypoglycemia  1  2/34 (5.88%) 
Hypokalemia  1  12/34 (35.29%) 
Hypomagnesemia  1  2/34 (5.88%) 
Hyponatremia  1  9/34 (26.47%) 
Hypophosphatemia  1  8/34 (23.53%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  6/34 (17.65%) 
Back pain  1  9/34 (26.47%) 
Generalized muscle weakness  1  3/34 (8.82%) 
Myalgia  1  3/34 (8.82%) 
Pain in extremity  1  7/34 (20.59%) 
Nervous system disorders   
Dizziness  1  3/34 (8.82%) 
Dysarthria  1  2/34 (5.88%) 
Dysgeusia  1  3/34 (8.82%) 
Headache  1  4/34 (11.76%) 
Peripheral sensory neuropathy  1  2/34 (5.88%) 
Psychiatric disorders   
Insomnia  1  5/34 (14.71%) 
Renal and urinary disorders   
Urine discoloration  1  2/34 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/34 (8.82%) 
Epistaxis  1  2/34 (5.88%) 
Productive cough  1  3/34 (8.82%) 
Voice alteration  1  2/34 (5.88%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  6/34 (17.65%) 
Dry skin  1  5/34 (14.71%) 
Hyperhidrosis  1  2/34 (5.88%) 
Palmar-plantar erythrodysesthesia syndrome  1  10/34 (29.41%) 
Pruritus  1  3/34 (8.82%) 
Rash acneiform  1  17/34 (50.00%) 
Rash maculo-papular  1  11/34 (32.35%) 
Skin hyperpigmentation  1  2/34 (5.88%) 
Vascular disorders   
Hypertension  1  12/34 (35.29%) 
Hypotension  1  2/34 (5.88%) 
Thromboembolic event  1  2/34 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
The first stage of accrual was met with 40 registered patients. Insufficient number of patients were alive and free from progression at four months to warrant accruing to a second stage.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Study Statistician
Organization: SWOG
Phone: 206-667-4623
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01093222     History of Changes
Other Study ID Numbers: NCI-2011-02027
NCI-2011-02027 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SWOG-S0941
CDR0000668246
S0941 ( Other Identifier: SWOG )
S0941 ( Other Identifier: CTEP )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: March 24, 2010
First Posted: March 25, 2010
Results First Submitted: November 1, 2013
Results First Posted: January 29, 2014
Last Update Posted: June 30, 2015