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Trial record 2 of 857 for:    Pancreatic Cancer AND Progression-free survival

Sorafenib and Erlotinib in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT00837876
Recruitment Status : Completed
First Posted : February 6, 2009
Results First Posted : September 28, 2012
Last Update Posted : June 25, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jordan Berlin, MD, Vanderbilt-Ingram Cancer Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Sorafenib
Drug: Erlotinb
Enrollment 37
Recruitment Details This study enrolled patients from October 2008 until February 2011.
Pre-assignment Details 37 patients consented and went on study. Six patients were ineligible.
Arm/Group Title Treatment
Hide Arm/Group Description Sorafenib + Erlotinib
Period Title: Overall Study
Started 37
Completed 0
Not Completed 37
Reason Not Completed
Death             2
Adverse Event             7
Physician Decision             1
Withdrawal by Subject             3
disease progression             24
Arm/Group Title Treatment
Hide Arm/Group Description Sorafenib + Erlotinib
Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
<=18 years
0
   0.0%
Between 18 and 65 years
21
  56.8%
>=65 years
16
  43.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants
62  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
18
  48.6%
Male
19
  51.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants
37
1.Primary Outcome
Title Number of Patients With Progression-free Survival
Hide Description Number of patients with progression-free survival at 8 weeks
Time Frame at 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received treatment for >= 8 weeks. 14 study patients were treated for < 8 weeks due to toxicity (5), disease progression (5), did not receive study drug (1), respiratory failure (1), drug held more than 28 days (1), patient withdrawal (1). The remaining 13 participants did not have a progression-free survival at 8 weeks.
Arm/Group Title Treatment
Hide Arm/Group Description:
Sorafenib + Erlotinib
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: participants
10
2.Secondary Outcome
Title Response Rate
Hide Description Per RECIST criteria v. 1.0: measurable lesions: CR disappearance of target lesions, PR > 30% decrease in the sum of the longest diameter (LD) of target lesions, PD > 20% increase in the sum of the LD of target lesions or appearance of new lesions, SD neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
Time Frame at 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received treatment for 4 or more months. The remaining 10 participants received treatment for less than 4 months and were not evaluable.
Arm/Group Title Treatment
Hide Arm/Group Description:
Sorafenib + Erlotinib
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
Complete Response 0
Partial Response 0
Stable Disease 8
Progressive Disease 19
3.Secondary Outcome
Title Number of Patients With Progression-free Survival
Hide Description Participants with progression-free survival at 4 months.
Time Frame at 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with progression-free survival at 4 months. The remaining 17 patients were not available for evaluation at 4 months due to toxicity (5), disease progression (5), patient withdrawal (1),respiratory failure (1), study drug held more than 28 days (1), and no study drug (1.
Arm/Group Title Treatment
Hide Arm/Group Description:
Sorafenib + Erlotinib
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
4
4.Secondary Outcome
Title Number of Patients With Worst Grade Toxicities
Hide Description Number of patients with worst-grade toxicity at each of five grades (grade 1 to 5, with 5 most severe) following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death.
Time Frame every 4 weeks and every 8 weeks in follow-up to resolution of toxicity
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received treatment with the study drugs. One patient did not receive treatment.
Arm/Group Title Treatment
Hide Arm/Group Description:
Sorafenib + Erlotinib
Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: participants
number of patients with worst grade toxicity - 1 1
number of patients with worst grade toxicity - 2 5
number of patients with worst grade toxicity - 3 26
number of patients with worst grade toxicity - 4 3
number of patients with worst grade toxicity - 5 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description Sorafenib + Erlotinib
All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment
Affected / at Risk (%) # Events
Total   27/37 (72.97%)    
Cardiac disorders   
cardiac ischemia/infarction  1/37 (2.70%)  1
Gastrointestinal disorders   
nausea  9/37 (24.32%)  14
vomiting  7/37 (18.92%)  11
constipation  1/37 (2.70%)  1
dehydration  5/37 (13.51%)  7
pain in abdomen  10/37 (27.03%)  15
diarrhea  2/37 (5.41%)  2
enteritis  1/37 (2.70%)  1
hemorrhage, GI  1/37 (2.70%)  1
obstruction, GI  1/37 (2.70%)  1
distension, abdominal  1/37 (2.70%)  1
pain in stomach  1/37 (2.70%)  1
General disorders   
Pain, NOS  5/37 (13.51%)  10
death - NOS  2/37 (5.41%)  2
fatigue  4/37 (10.81%)  4
fever  2/37 (5.41%)  2
pain, right upper quadrant  2/37 (5.41%)  2
edema, limb  1/37 (2.70%)  1
Infections and infestations   
infection with unknown ANC, artery  1/37 (2.70%)  1
bladder infection  1/37 (2.70%)  1
infection, normal ANC  1/37 (2.70%)  1
infection, Hickman catheter  1/37 (2.70%)  1
infection with unknown ANC, blood  2/37 (5.41%)  2
infection with unknown ANC, wound  1/37 (2.70%)  1
infection with unknown ANC, lung  1/37 (2.70%)  2
appendicitis  1/37 (2.70%)  1
Investigations   
hemoglobin  2/37 (5.41%)  3
Metabolism and nutrition disorders   
acidosis  1/37 (2.70%)  1
hyperglycemia  1/37 (2.70%)  1
hyperbilirubinemia  5/37 (13.51%)  6
hyponatremia  1/37 (2.70%)  1
calcium, serum-low-hypocalcemia  2/37 (5.41%)  2
hypokalemia  2/37 (5.41%)  2
hypochloremia  1/37 (2.70%)  1
AST, SGOT  2/37 (5.41%)  2
alkaline phosphatase  1/37 (2.70%)  1
ammonia level increase  1/37 (2.70%)  1
Musculoskeletal and connective tissue disorders   
pain in back  3/37 (8.11%)  4
Pregnancy, puerperium and perinatal conditions   
hypocalcemia  1/37 (2.70%)  1
Psychiatric disorders   
confusion  5/37 (13.51%)  7
Respiratory, thoracic and mediastinal disorders   
dyspnea  3/37 (8.11%)  5
pulmonary, upper respiratory  2/37 (5.41%)  2
Skin and subcutaneous tissue disorders   
skin rash  1/37 (2.70%)  1
Vascular disorders   
thrombosis  2/37 (5.41%)  2
deep vein thrombosis  1/37 (2.70%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment
Affected / at Risk (%) # Events
Total   36/37 (97.30%)    
Cardiac disorders   
Hypertension  6/37 (16.22%)  10
Gastrointestinal disorders   
diarrhea  21/37 (56.76%)  40
nausea  15/37 (40.54%)  22
vomiting  10/37 (27.03%)  11
dehydration  9/37 (24.32%)  11
mucositis/stomatitis  9/37 (24.32%)  10
constipation  8/37 (21.62%)  8
flatulence  8/37 (21.62%)  10
heartburn/dyspepsia  2/37 (5.41%)  3
pain, abdomen NOS  9/37 (24.32%)  20
Taste alteration  3/37 (8.11%)  4
General disorders   
fatigue  22/37 (59.46%)  42
edema limb  3/37 (8.11%)  3
constitutional symptoms, other  7/37 (18.92%)  21
Infections and infestations   
fever (in the absence of neutropenia , where neutropenia is defined as ANC<1.0 x 10e9/L)  3/37 (8.11%)  4
Infection-other  2/37 (5.41%)  3
Investigations   
alkaline phosphatase  18/37 (48.65%)  25
hemoglobin  17/37 (45.95%)  33
lymphopenia  12/37 (32.43%)  30
platelets  8/37 (21.62%)  11
Metabolism and nutrition disorders   
anorexia  14/37 (37.84%)  19
weight loss  12/37 (32.43%)  17
hyperglycemia  19/37 (51.35%)  36
AST, SGOT  14/37 (37.84%)  27
ALT, SGPT  13/37 (35.14%)  24
hyponatremia-sodium, low  10/13 (76.92%)  13
hypokalemia  9/37 (24.32%)  15
hyperbilirubinemia  8/37 (21.62%)  19
hypocalcemia  6/37 (16.22%)  8
hypomagnesemia  4/37 (10.81%)  4
hypophosphatemia  4/37 (10.81%)  10
hypermagnesemia  2/37 (5.41%)  2
leukocytes  5/37 (13.51%)  9
albumin, serum-low  15/37 (40.54%)  21
glucose, serum-high-hyperglycemia  7/37 (18.92%)  8
Metabolic/Laboratory, other  2/37 (5.41%)  3
Musculoskeletal and connective tissue disorders   
pain, back  6/37 (16.22%)  8
Musculoskeletal/soft tissue-other  3/37 (8.11%)  3
Nervous system disorders   
pain, headaches  3/37 (8.11%)  3
dysarthria/voice changes  6/37 (16.22%)  7
Neuropathy-sensory  3/37 (8.11%)  4
Insomnia  2/37 (5.41%)  2
Tremor  2/37 (5.41%)  2
Psychiatric disorders   
depression  3/37 (8.11%)  3
Respiratory, thoracic and mediastinal disorders   
dyspnea  4/37 (10.81%)  4
cough  3/37 (8.11%)  3
confusion  3/37 (8.11%)  4
Pain-chest/thorax  2/37 (5.41%)  5
Pain-sinus  2/37 (5.41%)  2
pain-throat/pharynx/larynx  2/37 (5.41%)  2
Pulmonary/Upper Respiratory, other  2/37 (5.41%)  2
Infection with unknown ANC-upper airway NOS  2/37 (5.41%)  2
Skin and subcutaneous tissue disorders   
rash-acne/acneiform  17/37 (45.95%)  22
dry skin  9/37 (24.32%)  9
rash-hand-foot skin reaction  7/37 (18.92%)  18
sweating  2/37 (5.41%)  2
dermatology/Skin, other  3/37 (8.11%)  5
Pruritis, itching  2/37 (5.41%)  2
Vascular disorders   
Vascular-other  2/37 (5.41%)  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: Jordan Berlin, MD
Organization: Vanderbilt-Ingram Cancer Center
Phone: 615-343-4128
EMail: jordan.berlin@vanderbilt.edu
Layout table for additonal information
Responsible Party: Jordan Berlin, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00837876     History of Changes
Other Study ID Numbers: VICC GI 0815
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-GI-0815
First Submitted: February 5, 2009
First Posted: February 6, 2009
Results First Submitted: April 2, 2012
Results First Posted: September 28, 2012
Last Update Posted: June 25, 2014