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S0727 Gemcitabine Hydrochloride and Erlotinib Hydrochloride With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00617708
Recruitment Status : Completed
First Posted : February 18, 2008
Results First Posted : December 5, 2013
Last Update Posted : July 31, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stage IV Pancreatic Cancer
Interventions Biological: cixutumumab
Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride
Enrollment 134
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ph I: Erlotinib + Gemcitabine + IMC-A12 Ph II: Erlotinib + Gemcitabine + IMC-A12 Ph II: Erlotinib + Gemcitabine
Hide Arm/Group Description Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days. Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days. Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
Period Title: Overall Study
Started 10 60 64
Eligible and Began Protocol Therapy 9 57 59
Completed 0 0 0
Not Completed 10 60 64
Reason Not Completed
Adverse Event             0             6             9
Withdrawal by Subject             1             1             7
Death             0             6             5
Progression/Relapse             7             40             36
Not protocol specified             1             4             2
Not eligible             1             3             5
Arm/Group Title Ph I: Erlotinib + Gemcitabine + IMC-A12 Ph II: Erlotinib + Gemcitabine + IMC-A12 Ph II: Erlotinib + Gemcitabine Total
Hide Arm/Group Description Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days. Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days. Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days. Total of all reporting groups
Overall Number of Baseline Participants 9 57 59 125
Hide Baseline Analysis Population Description
Eligible patients who began protocol therapy
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants 57 participants 59 participants 125 participants
61
(39 to 82)
63
(36 to 87)
64
(42 to 82)
63
(35 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 57 participants 59 participants 125 participants
Female
3
  33.3%
34
  59.6%
25
  42.4%
62
  49.6%
Male
6
  66.7%
23
  40.4%
34
  57.6%
63
  50.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 57 participants 59 participants 125 participants
White 5 44 51 100
Black 2 10 6 18
Asian 1 2 2 5
Unknown 1 1 0 2
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 57 participants 59 participants 125 participants
Hispanic 1 3 5 9
Non-Hispanic 8 53 47 108
Unknown 0 1 7 8
1.Primary Outcome
Title Maximum Tolerated Dose Determination
Hide Description Maximum dose of IMC-A12 (in combination with erlotinib and gemcitabine) at which 3/10 or fewer patients have dose-limiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I patients receiving at least three doses of the assigned dose during Cycle 1 or whom developed a DLT.
Arm/Group Title Ph I: Erlotinib + Gemcitabine + IMC-A12
Hide Arm/Group Description:
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: mg/kg IMC-A12
6
2.Primary Outcome
Title Progression-Free Survival
Hide Description From date of registration to date of first documentation of progression or symptomatic deterioration, 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 in the Phase II portion of the study.
Arm/Group Title Erlotinib + Gemcitabine + IMC-A12 Erlotinib + Gemcitabine
Hide Arm/Group Description:
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
Overall Number of Participants Analyzed 57 59
Median (95% Confidence Interval)
Unit of Measure: months
3.6
(2.4 to 5.3)
3.6
(1.8 to 5.3)
3.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 in the Phase II portion of the study.
Arm/Group Title Erlotinib + Gemcitabine + IMC-A12 Erlotinib + Gemcitabine
Hide Arm/Group Description:
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
Overall Number of Participants Analyzed 57 59
Median (95% Confidence Interval)
Unit of Measure: months
7.0
(4.2 to 8.9)
6.5
(5.0 to 7.7)
4.Secondary Outcome
Title Response
Hide Description Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) 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 in the Phase II portion of the study with measurable disease and adequate response assessment.
Arm/Group Title Erlotinib + Gemcitabine + IMC-A12 Erlotinib + Gemcitabine
Hide Arm/Group Description:
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
Overall Number of Participants Analyzed 51 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.7
(5.7 to 26.3)
15.3
(7.2 to 27.0)
5.Secondary Outcome
Title Toxicity
Hide Description Number of patients with Grade 3 through 5 adverse events that are related to study drug. 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 3.0 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 Ph I: Erlotinib + Gemcitabine + IMC-A12 Ph II: Erlotinib + Gemcitabine + IMC-A12 Ph II: Erlotinib + Gemcitabine
Hide Arm/Group Description:
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
Overall Number of Participants Analyzed 9 57 57
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 0 9 4
AST, SGOT 0 6 3
Acidosis (metabolic or respiratory) 0 1 0
Adult respiratory distress syndrome (ARDS) 0 0 1
Albumin, serum-low (hypoalbuminemia) 0 3 0
Alkaline phosphatase 0 4 3
Allergic reaction/hypersensitivity 1 0 0
Anorexia 1 7 6
Bilirubin (hyperbilirubinemia) 0 5 0
Calcium, serum-low (hypocalcemia) 0 1 1
Cardiac troponin I (cTnI) 0 3 0
Cardiac-ischemia/infarction 0 0 1
Cardiopulmonary arrest, cause unknown (non-fatal) 0 0 1
Dehydration 3 6 5
Diarrhea 2 3 2
Dizziness 0 1 0
Dysphagia (difficulty swallowing) 0 0 1
Dyspnea (shortness of breath) 0 2 4
Edema: limb 0 0 1
Edema: trunk/genital 0 0 1
Fatigue (asthenia, lethargy, malaise) 4 16 12
GGT (gamma-glutamyl transpeptidase) 0 1 0
Glucose, serum-high (hyperglycemia) 2 16 1
Hemoglobin 0 9 8
Hypotension 0 3 1
Hypoxia 0 1 2
Inf (clin/microbio) w/Gr 3-4 neuts - Blood 0 0 1
Inf (clin/microbio) w/Gr 3-4 neuts - UTI 0 0 1
Inf w/normal ANC or Gr 1-2 neutrophils - Bil. tree 0 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - Blood 1 0 1
Inf w/normal ANC or Gr 1-2 neutrophils - Lung 0 1 2
Inf w/normal ANC or Gr 1-2 neutrophils - Pancreas 0 0 1
Inf w/normal ANC or Gr 1-2 neutrophils - Skin 0 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - UTI 0 0 1
Inf w/normal ANC or Gr 1-2 neutrophils -Up aerodig 0 1 0
Infection-Other (Specify) 0 1 0
Left ventricular systolic dysfunction 0 1 0
Leukocytes (total WBC) 1 9 5
Liver dysfunction/failure (clinical) 0 0 1
Lymphatics-Other (Specify) 0 0 1
Lymphopenia 1 4 5
Magnesium, serum-low (hypomagnesemia) 0 1 0
Mucositis/stomatitis (functional/symp) - Oral cav 0 1 0
Muscle weakness, not d/t neuropathy - Extrem-lower 0 1 0
Muscle weakness, not d/t neuropathy - body/general 0 5 3
Nausea 4 9 6
Neuropathy: sensory 0 1 0
Neutrophils/granulocytes (ANC/AGC) 3 21 10
Obstruction, GI - Duodenum 0 0 1
Opportunistic inf associated w/gt=Gr 2 lymphopenia 1 0 0
PTT (Partial thromboplastin time) 0 1 0
Pain - Abdomen NOS 0 0 1
Pain - Eye 0 1 0
Pain - Head/headache 0 1 0
Pain - Muscle 0 0 1
Pancreas, exocrine enzyme deficiency 0 1 0
Pancreatic endocrine: glucose intolerance 0 6 0
Pericardial effusion (non-malignant) 0 0 1
Personality/behavioral 0 1 0
Platelets 2 16 7
Pleural effusion (non-malignant) 0 0 1
Pneumonitis/pulmonary infiltrates 0 1 2
Potassium, serum-low (hypokalemia) 0 1 1
Pulmonary/Upper Respiratory-Other (Specify) 0 1 1
Rash/desquamation 0 0 1
Rash: acne/acneiform 0 3 2
Rash: erythema multiforme 0 1 0
SVT and nodal arrhythmia - Atrial fibrillation 0 1 0
Sodium, serum-low (hyponatremia) 1 5 1
Stricture/stenosis (incl anastomotic), Stomach 0 0 1
Syncope (fainting) 0 3 0
Thrombosis/embolism (vascular access-related) 0 1 0
Thrombosis/thrombus/embolism 0 4 1
Tremor 0 1 0
Uric acid, serum-high (hyperuricemia) 0 1 0
Ventricular arrhythmia - Ventricular fibrillation 0 1 0
Vision-blurred vision 0 1 0
Vision-photophobia 0 1 0
Vomiting 2 5 1
Weight loss 0 2 0
Time Frame Up to 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ph I: Erlotinib + Gemcitabine + IMC-A12 Ph II: Erlotinib + Gemcitabine + IMC-A12 Ph II: Erlotinib + Gemcitabine
Hide Arm/Group Description Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days. Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days. Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
All-Cause Mortality
Ph I: Erlotinib + Gemcitabine + IMC-A12 Ph II: Erlotinib + Gemcitabine + IMC-A12 Ph II: Erlotinib + Gemcitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Ph I: Erlotinib + Gemcitabine + IMC-A12 Ph II: Erlotinib + Gemcitabine + IMC-A12 Ph II: Erlotinib + Gemcitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/9 (55.56%)   34/57 (59.65%)   33/57 (57.89%) 
Blood and lymphatic system disorders       
Hemoglobin  1  0/9 (0.00%)  6/57 (10.53%)  2/57 (3.51%) 
Lymphatics-Other (Specify)  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Cardiac disorders       
Atrioventricular block - first degree  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Cardiac-ischemia/infarction  1  0/9 (0.00%)  1/57 (1.75%)  2/57 (3.51%) 
Left ventricular systolic dysfunction  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Pericardial effusion (non-malignant)  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
SVT and nodal arrhythmia - Atrial fibrillation  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Ventricular arrhythmia - Ventricular fibrillation  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Gastrointestinal disorders       
Ascites (non-malignant)  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Constipation  1  0/9 (0.00%)  1/57 (1.75%)  1/57 (1.75%) 
Diarrhea  1  1/9 (11.11%)  1/57 (1.75%)  0/57 (0.00%) 
Distention/bloating, abdominal  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Gastrointestinal-Other (Specify)  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Hemorrhage, GI - Duodenum  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Hemorrhage, GI - Rectum  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Hemorrhage, GI - Upper GI NOS  1  0/9 (0.00%)  1/57 (1.75%)  1/57 (1.75%) 
Ileus, GI (functional obstruction of bowel)  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Incontinence, anal  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Nausea  1  3/9 (33.33%)  3/57 (5.26%)  3/57 (5.26%) 
Obstruction, GI - Duodenum  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Obstruction, GI - Small bowel NOS  1  1/9 (11.11%)  0/57 (0.00%)  1/57 (1.75%) 
Obstruction, GI - Stomach  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Pain - Abdomen NOS  1  0/9 (0.00%)  9/57 (15.79%)  3/57 (5.26%) 
Vomiting  1  2/9 (22.22%)  4/57 (7.02%)  3/57 (5.26%) 
General disorders       
Death not associated with CTCAE term - Death NOS  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Edema: limb  1  0/9 (0.00%)  1/57 (1.75%)  1/57 (1.75%) 
Fatigue (asthenia, lethargy, malaise)  1  1/9 (11.11%)  3/57 (5.26%)  4/57 (7.02%) 
Hepatobiliary disorders       
Hepatobiliary/Pancreas-Other (Specify)  1  0/9 (0.00%)  2/57 (3.51%)  0/57 (0.00%) 
Liver dysfunction/failure (clinical)  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Portal vein flow  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Stricture/stenosis (incl anastomotic)-Biliary tree  1  0/9 (0.00%)  0/57 (0.00%)  2/57 (3.51%) 
Immune system disorders       
Allergic reaction/hypersensitivity  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Infections and infestations       
Inf (clin/microbio) w/Gr 3-4 neuts - Blood  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Bil. tree  1  0/9 (0.00%)  1/57 (1.75%)  1/57 (1.75%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Blood  1  1/9 (11.11%)  0/57 (0.00%)  1/57 (1.75%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lung  1  0/9 (0.00%)  1/57 (1.75%)  2/57 (3.51%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Pancreas  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Perit cav  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Skin  1  0/9 (0.00%)  2/57 (3.51%)  1/57 (1.75%) 
Inf w/normal ANC or Gr 1-2 neutrophils - UTI  1  0/9 (0.00%)  1/57 (1.75%)  1/57 (1.75%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils -Up aerodig  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils-Foreign bod  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Infection with unknown ANC - Blood  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Injury, poisoning and procedural complications       
Fracture  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Thrombosis/embolism (vascular access-related)  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Investigations       
ALT, SGPT (serum glutamic pyruvic transaminase)  1  0/9 (0.00%)  1/57 (1.75%)  1/57 (1.75%) 
AST, SGOT  1  0/9 (0.00%)  1/57 (1.75%)  2/57 (3.51%) 
Alkaline phosphatase  1  0/9 (0.00%)  1/57 (1.75%)  2/57 (3.51%) 
Amylase  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Bilirubin (hyperbilirubinemia)  1  0/9 (0.00%)  5/57 (8.77%)  2/57 (3.51%) 
Cardiac troponin I (cTnI)  1  0/9 (0.00%)  2/57 (3.51%)  1/57 (1.75%) 
Creatinine  1  1/9 (11.11%)  1/57 (1.75%)  0/57 (0.00%) 
Lipase  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Lymphopenia  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Pancreas, exocrine enzyme deficiency  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Platelets  1  0/9 (0.00%)  2/57 (3.51%)  0/57 (0.00%) 
Weight loss  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Metabolism and nutrition disorders       
Acidosis (metabolic or respiratory)  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Albumin, serum-low (hypoalbuminemia)  1  0/9 (0.00%)  3/57 (5.26%)  0/57 (0.00%) 
Anorexia  1  0/9 (0.00%)  1/57 (1.75%)  2/57 (3.51%) 
Calcium, serum-low (hypocalcemia)  1  0/9 (0.00%)  1/57 (1.75%)  1/57 (1.75%) 
Dehydration  1  4/9 (44.44%)  6/57 (10.53%)  5/57 (8.77%) 
Glucose, serum-high (hyperglycemia)  1  0/9 (0.00%)  4/57 (7.02%)  1/57 (1.75%) 
Potassium, serum-low (hypokalemia)  1  0/9 (0.00%)  1/57 (1.75%)  2/57 (3.51%) 
Sodium, serum-low (hyponatremia)  1  0/9 (0.00%)  3/57 (5.26%)  0/57 (0.00%) 
Uric acid, serum-high (hyperuricemia)  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthritis (non-septic)  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Muscle weakness, not d/t neuropathy - body/general  1  0/9 (0.00%)  5/57 (8.77%)  1/57 (1.75%) 
Pain - Back  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Pain - Muscle  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Death - Disease progression NOS  1  1/9 (11.11%)  9/57 (15.79%)  10/57 (17.54%) 
Pain - Tumor pain  1  0/9 (0.00%)  3/57 (5.26%)  1/57 (1.75%) 
Nervous system disorders       
CNS cerebrovascular ischemia  1  0/9 (0.00%)  1/57 (1.75%)  1/57 (1.75%) 
Dizziness  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Neuropathy: motor  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Syncope (fainting)  1  0/9 (0.00%)  2/57 (3.51%)  0/57 (0.00%) 
Psychiatric disorders       
Confusion  1  1/9 (11.11%)  2/57 (3.51%)  0/57 (0.00%) 
Mood alteration - agitation  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Personality/behavioral  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Psychosis (hallucinations/delusions)  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Renal and urinary disorders       
Incontinence, urinary  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome (ARDS)  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Dyspnea (shortness of breath)  1  0/9 (0.00%)  2/57 (3.51%)  5/57 (8.77%) 
Hypoxia  1  0/9 (0.00%)  1/57 (1.75%)  3/57 (5.26%) 
Pleural effusion (non-malignant)  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Pneumonitis/pulmonary infiltrates  1  0/9 (0.00%)  1/57 (1.75%)  3/57 (5.26%) 
Pulmonary/Upper Respiratory-Other (Specify)  1  0/9 (0.00%)  1/57 (1.75%)  1/57 (1.75%) 
Skin and subcutaneous tissue disorders       
Rash/desquamation  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Rash: acne/acneiform  1  0/9 (0.00%)  0/57 (0.00%)  1/57 (1.75%) 
Skin breakdown/decubitus ulcer  1  0/9 (0.00%)  1/57 (1.75%)  0/57 (0.00%) 
Vascular disorders       
Hypotension  1  0/9 (0.00%)  2/57 (3.51%)  3/57 (5.26%) 
Thrombosis/thrombus/embolism  1  0/9 (0.00%)  5/57 (8.77%)  3/57 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ph I: Erlotinib + Gemcitabine + IMC-A12 Ph II: Erlotinib + Gemcitabine + IMC-A12 Ph II: Erlotinib + Gemcitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/9 (100.00%)   56/57 (98.25%)   57/57 (100.00%) 
Blood and lymphatic system disorders       
Hemoglobin  1  8/9 (88.89%)  38/57 (66.67%)  39/57 (68.42%) 
Cardiac disorders       
Cardiac Arrhythmia-Other (Specify)  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Cardiac-ischemia/infarction  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
SVT and nodal arrhythmia - Atrial tachycardia/PAT  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
SVT and nodal arrhythmia - Sinus bradycardia  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Ear and labyrinth disorders       
Auditory/Ear-Other (Specify)  1  2/9 (22.22%)  0/57 (0.00%)  0/57 (0.00%) 
Eye disorders       
Dry eye syndrome  1  1/9 (11.11%)  4/57 (7.02%)  0/57 (0.00%) 
Ocular/Visual-Other (Specify)  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Vision-blurred vision  1  0/9 (0.00%)  5/57 (8.77%)  4/57 (7.02%) 
Vision-flashing lights/floaters  1  3/9 (33.33%)  3/57 (5.26%)  0/57 (0.00%) 
Gastrointestinal disorders       
Constipation  1  7/9 (77.78%)  33/57 (57.89%)  27/57 (47.37%) 
Diarrhea  1  5/9 (55.56%)  32/57 (56.14%)  27/57 (47.37%) 
Distention/bloating, abdominal  1  0/9 (0.00%)  0/57 (0.00%)  3/57 (5.26%) 
Dry mouth/salivary gland (xerostomia)  1  1/9 (11.11%)  6/57 (10.53%)  5/57 (8.77%) 
Flatulence  1  0/9 (0.00%)  3/57 (5.26%)  5/57 (8.77%) 
Gastrointestinal-Other (Specify)  1  0/9 (0.00%)  3/57 (5.26%)  5/57 (8.77%) 
Heartburn/dyspepsia  1  3/9 (33.33%)  10/57 (17.54%)  4/57 (7.02%) 
Hemorrhage, GI - Abdomen NOS  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Hemorrhoids  1  1/9 (11.11%)  4/57 (7.02%)  0/57 (0.00%) 
Malabsorption  1  0/9 (0.00%)  0/57 (0.00%)  3/57 (5.26%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  1/9 (11.11%)  17/57 (29.82%)  0/57 (0.00%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  2/9 (22.22%)  10/57 (17.54%)  4/57 (7.02%) 
Nausea  1  9/9 (100.00%)  43/57 (75.44%)  34/57 (59.65%) 
Obstruction, GI - Small bowel NOS  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Pain - Abdomen NOS  1  5/9 (55.56%)  17/57 (29.82%)  21/57 (36.84%) 
Pain - Oral cavity  1  0/9 (0.00%)  4/57 (7.02%)  0/57 (0.00%) 
Pain - Rectum  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Pain - Stomach  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Vomiting  1  6/9 (66.67%)  26/57 (45.61%)  25/57 (43.86%) 
General disorders       
Edema: limb  1  1/9 (11.11%)  12/57 (21.05%)  16/57 (28.07%) 
Fatigue (asthenia, lethargy, malaise)  1  8/9 (88.89%)  47/57 (82.46%)  43/57 (75.44%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  3/9 (33.33%)  5/57 (8.77%)  15/57 (26.32%) 
Pain - Chest/thorax NOS  1  0/9 (0.00%)  3/57 (5.26%)  0/57 (0.00%) 
Pain-Other (Specify)  1  0/9 (0.00%)  7/57 (12.28%)  3/57 (5.26%) 
Rigors/chills  1  1/9 (11.11%)  5/57 (8.77%)  7/57 (12.28%) 
Immune system disorders       
Allergic reaction/hypersensitivity  1  0/9 (0.00%)  0/57 (0.00%)  3/57 (5.26%) 
Allergy/Immunology-Other (Specify)  1  0/9 (0.00%)  3/57 (5.26%)  0/57 (0.00%) 
Infections and infestations       
Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Skin  1  2/9 (22.22%)  3/57 (5.26%)  0/57 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - UTI  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Infection-Other (Specify)  1  0/9 (0.00%)  3/57 (5.26%)  3/57 (5.26%) 
Opportunistic inf associated w/gt=Gr 2 lymphopenia  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Injury, poisoning and procedural complications       
Bruising (in absence of Gr 3-4 thrombocytopenia)  1  2/9 (22.22%)  0/57 (0.00%)  0/57 (0.00%) 
Investigations       
ALT, SGPT (serum glutamic pyruvic transaminase)  1  8/9 (88.89%)  34/57 (59.65%)  30/57 (52.63%) 
AST, SGOT  1  8/9 (88.89%)  36/57 (63.16%)  31/57 (54.39%) 
Alkaline phosphatase  1  5/9 (55.56%)  35/57 (61.40%)  25/57 (43.86%) 
Bilirubin (hyperbilirubinemia)  1  3/9 (33.33%)  18/57 (31.58%)  18/57 (31.58%) 
Creatinine  1  3/9 (33.33%)  9/57 (15.79%)  8/57 (14.04%) 
INR (of prothrombin time)  1  0/9 (0.00%)  4/57 (7.02%)  7/57 (12.28%) 
Leukocytes (total WBC)  1  4/9 (44.44%)  29/57 (50.88%)  29/57 (50.88%) 
Lymphopenia  1  1/9 (11.11%)  8/57 (14.04%)  10/57 (17.54%) 
Metabolic/Laboratory-Other (Specify)  1  0/9 (0.00%)  5/57 (8.77%)  4/57 (7.02%) 
Neutrophils/granulocytes (ANC/AGC)  1  6/9 (66.67%)  30/57 (52.63%)  20/57 (35.09%) 
PTT (Partial thromboplastin time)  1  0/9 (0.00%)  3/57 (5.26%)  4/57 (7.02%) 
Platelets  1  9/9 (100.00%)  42/57 (73.68%)  36/57 (63.16%) 
Weight loss  1  3/9 (33.33%)  27/57 (47.37%)  25/57 (43.86%) 
Metabolism and nutrition disorders       
Albumin, serum-low (hypoalbuminemia)  1  2/9 (22.22%)  25/57 (43.86%)  18/57 (31.58%) 
Anorexia  1  5/9 (55.56%)  35/57 (61.40%)  31/57 (54.39%) 
Calcium, serum-high (hypercalcemia)  1  2/9 (22.22%)  0/57 (0.00%)  0/57 (0.00%) 
Calcium, serum-low (hypocalcemia)  1  2/9 (22.22%)  18/57 (31.58%)  14/57 (24.56%) 
Dehydration  1  2/9 (22.22%)  12/57 (21.05%)  11/57 (19.30%) 
Glucose, serum-high (hyperglycemia)  1  9/9 (100.00%)  27/57 (47.37%)  29/57 (50.88%) 
Glucose, serum-low (hypoglycemia)  1  0/9 (0.00%)  7/57 (12.28%)  4/57 (7.02%) 
Magnesium, serum-low (hypomagnesemia)  1  2/9 (22.22%)  5/57 (8.77%)  5/57 (8.77%) 
Pancreatic endocrine: glucose intolerance  1  0/9 (0.00%)  7/57 (12.28%)  0/57 (0.00%) 
Phosphate, serum-low (hypophosphatemia)  1  2/9 (22.22%)  4/57 (7.02%)  0/57 (0.00%) 
Potassium, serum-high (hyperkalemia)  1  2/9 (22.22%)  11/57 (19.30%)  4/57 (7.02%) 
Potassium, serum-low (hypokalemia)  1  1/9 (11.11%)  10/57 (17.54%)  15/57 (26.32%) 
Sodium, serum-low (hyponatremia)  1  3/9 (33.33%)  19/57 (33.33%)  19/57 (33.33%) 
Musculoskeletal and connective tissue disorders       
Muscle weakness, not d/t neuropathy - Extrem-lower  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Muscle weakness, not d/t neuropathy - body/general  1  2/9 (22.22%)  10/57 (17.54%)  9/57 (15.79%) 
Pain - Back  1  2/9 (22.22%)  13/57 (22.81%)  8/57 (14.04%) 
Pain - Extremity-limb  1  0/9 (0.00%)  3/57 (5.26%)  0/57 (0.00%) 
Pain - Joint  1  3/9 (33.33%)  7/57 (12.28%)  3/57 (5.26%) 
Pain - Muscle  1  1/9 (11.11%)  3/57 (5.26%)  0/57 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Pain - Tumor pain  1  3/9 (33.33%)  6/57 (10.53%)  7/57 (12.28%) 
Nervous system disorders       
Dizziness  1  2/9 (22.22%)  8/57 (14.04%)  7/57 (12.28%) 
Neuropathy: sensory  1  1/9 (11.11%)  9/57 (15.79%)  4/57 (7.02%) 
Ocular/Visual-Other (Specify)  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Pain - Head/headache  1  1/9 (11.11%)  6/57 (10.53%)  0/57 (0.00%) 
Syncope (fainting)  1  0/9 (0.00%)  3/57 (5.26%)  0/57 (0.00%) 
Taste alteration (dysgeusia)  1  3/9 (33.33%)  21/57 (36.84%)  16/57 (28.07%) 
Tremor  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Psychiatric disorders       
Confusion  1  1/9 (11.11%)  3/57 (5.26%)  0/57 (0.00%) 
Insomnia  1  2/9 (22.22%)  10/57 (17.54%)  12/57 (21.05%) 
Mood alteration - agitation  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Mood alteration - anxiety  1  1/9 (11.11%)  11/57 (19.30%)  8/57 (14.04%) 
Mood alteration - depression  1  3/9 (33.33%)  8/57 (14.04%)  5/57 (8.77%) 
Renal and urinary disorders       
Hemorrhage, GU - Urinary NOS  1  0/9 (0.00%)  0/57 (0.00%)  3/57 (5.26%) 
Renal failure  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Urinary frequency/urgency  1  0/9 (0.00%)  5/57 (8.77%)  0/57 (0.00%) 
Urinary retention (including neurogenic bladder)  1  0/9 (0.00%)  0/57 (0.00%)  4/57 (7.02%) 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis  1  0/9 (0.00%)  4/57 (7.02%)  0/57 (0.00%) 
Cough  1  2/9 (22.22%)  12/57 (21.05%)  8/57 (14.04%) 
Dyspnea (shortness of breath)  1  2/9 (22.22%)  15/57 (26.32%)  20/57 (35.09%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  1/9 (11.11%)  9/57 (15.79%)  0/57 (0.00%) 
Mucositis/stomatitis (clinical exam) - Pharynx  1  2/9 (22.22%)  0/57 (0.00%)  0/57 (0.00%) 
Nasal cavity/paranasal sinus reactions  1  1/9 (11.11%)  0/57 (0.00%)  0/57 (0.00%) 
Pleural effusion (non-malignant)  1  0/9 (0.00%)  0/57 (0.00%)  4/57 (7.02%) 
Voice changes/dysarthria  1  0/9 (0.00%)  4/57 (7.02%)  0/57 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatology/Skin-Other (Specify)  1  0/9 (0.00%)  5/57 (8.77%)  0/57 (0.00%) 
Dry skin  1  6/9 (66.67%)  13/57 (22.81%)  10/57 (17.54%) 
Hair loss/Alopecia (scalp or body)  1  1/9 (11.11%)  4/57 (7.02%)  10/57 (17.54%) 
Nail changes  1  0/9 (0.00%)  8/57 (14.04%)  0/57 (0.00%) 
Pruritus/itching  1  2/9 (22.22%)  12/57 (21.05%)  4/57 (7.02%) 
Rash/desquamation  1  2/9 (22.22%)  14/57 (24.56%)  22/57 (38.60%) 
Rash: acne/acneiform  1  6/9 (66.67%)  31/57 (54.39%)  24/57 (42.11%) 
Rash: hand-foot skin reaction  1  0/9 (0.00%)  4/57 (7.02%)  0/57 (0.00%) 
Sweating (diaphoresis)  1  1/9 (11.11%)  6/57 (10.53%)  6/57 (10.53%) 
Vascular disorders       
Hypertension  1  1/9 (11.11%)  4/57 (7.02%)  4/57 (7.02%) 
Hypotension  1  3/9 (33.33%)  6/57 (10.53%)  5/57 (8.77%) 
Thrombosis/thrombus/embolism  1  0/9 (0.00%)  4/57 (7.02%)  4/57 (7.02%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: NCT00617708    
Other Study ID Numbers: NCI-2009-00797
NCI-2009-00797 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000586427
SWOG-S0727
S0727 ( Other Identifier: Southwest Oncology Group )
S0727 ( Other Identifier: CTEP )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: February 15, 2008
First Posted: February 18, 2008
Results First Submitted: October 7, 2013
Results First Posted: December 5, 2013
Last Update Posted: July 31, 2014