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Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01557959
Recruitment Status : Completed
First Posted : March 20, 2012
Results First Posted : June 28, 2013
Last Update Posted : June 29, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
OSI Pharmaceuticals
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Lung
Adenosquamous Cell Lung Cancer
Bronchoalveolar Cell Lung Cancer
Large Cell Lung Cancer
Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Squamous Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Interventions Drug: cisplatin
Biological: pegfilgrastim
Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis
Genetic: polymorphism analysis
Other: pharmacogenomic studies
Genetic: genetic linkage analysis
Drug: docetaxel
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)
Hide Arm/Group Description Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 45
Completed 45
Not Completed 0
Arm/Group Title Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)
Hide Arm/Group Description Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
<=18 years
0
   0.0%
Between 18 and 65 years
31
  68.9%
>=65 years
14
  31.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants
58.6  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
20
  44.4%
Male
25
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants
45
1.Primary Outcome
Title Time to Progression
Hide Description Determined using RECIST. Estimated using the Kaplan-Meier method. Log-rank tests will be used to test for differences and Cox proportional hazards regression modeling will be used to adjust for patient demographics and characteristics such as smoking status at baseline (actively/non-actively smoking). Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)
Hide Arm/Group Description:
Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 45
Median (95% Confidence Interval)
Unit of Measure: months
4.63
(3.68 to 6.05)
2.Secondary Outcome
Title Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Pre-specified that data is only presented for the subgroups "Low Cyclin D1" and "High Cyclin D1".
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Cyclin D1 High Cyclin D1
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 16 15
Measure Type: Count of Participants
Unit of Measure: Participants
Progressive disease
3
  18.8%
4
  26.7%
Stable disease
9
  56.3%
9
  60.0%
Partial response
4
  25.0%
2
  13.3%
3.Secondary Outcome
Title Median Survival Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Cyclin D1 High Cyclin D1
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 16 15
Median (Standard Error)
Unit of Measure: Months
20.5  (7.7) 8.0  (10.7)
Time Frame [Not Specified]
Adverse Event Reporting Description 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
 
Arm/Group Title Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)
Hide Arm/Group Description Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)
Affected / at Risk (%) # Events
Total   39/44 (88.64%)    
Blood and lymphatic system disorders   
"Hemorrhage, GI: Duodenum"   1/44 (2.27%)  1
"Hemorrhage, CNS"   1/44 (2.27%)  1
"Hemorrhage, GI: Rectum"   1/44 (2.27%)  1
"Hemorrhage, pulmonary/upper respiratory: Respiratory tract NOS"   1/44 (2.27%)  1
Cardiac disorders   
Hypotension   1/44 (2.27%)  1
Atrial fibrillation   1/44 (2.27%)  1
Vasovagal episode   1/44 (2.27%)  1
Ear and labyrinth disorders   
Hearing: patients without baseline audiogram and not enrolled in a monitoring program   1/44 (2.27%)  1
Tinnitus   2/44 (4.55%)  2
Eye disorders   
Ocular/Visual - Other   1/44 (2.27%)  1
Gastrointestinal disorders   
Nausea   1/44 (2.27%)  1
Vomiting   3/44 (6.82%)  3
Diarrhea   7/44 (15.91%)  7
Constipation   1/44 (2.27%)  1
General disorders   
Anorexia   6/44 (13.64%)  6
Dizziness   1/44 (2.27%)  1
Insomnia   1/44 (2.27%)  1
Fatigue   3/44 (6.82%)  3
Weight loss   1/44 (2.27%)  1
Dysphagia   1/44 (2.27%)  1
Fever without neutropenia   1/44 (2.27%)  1
Urinary frequency/urgency   1/44 (2.27%)  1
Dehydration   3/44 (6.82%)  3
Confusion   1/44 (2.27%)  1
Pain: Joint   1/44 (2.27%)  1
Arthritis (non-septic)   1/44 (2.27%)  1
Pain: Bone   1/44 (2.27%)  1
Pain: Chest wall   2/44 (4.55%)  2
Muscle weakness   2/44 (4.55%)  2
Nail changes   1/44 (2.27%)  1
"Stricture/stenosis (including anastomotic), GI: Esophagus"   1/44 (2.27%)  1
Pain: Extremity-limb   1/44 (2.27%)  1
Pain (unspecified)   1/44 (2.27%)  1
Pain: Pleura   1/44 (2.27%)  1
Syncope (fainting)   3/44 (6.82%)  3
Death not associated with CTCAE term: Disease progression NOS   1/44 (2.27%)  1
Pain: Tumor pain   2/44 (4.55%)  2
Pain: External ear   1/44 (2.27%)  1
Immune system disorders   
Allergic reaction   2/44 (4.55%)  2
Infections and infestations   
Flu-like syndrome   1/44 (2.27%)  1
Lung infection   6/44 (13.64%)  6
Infection with unknown ANC: Blood   1/44 (2.27%)  1
Urinary with low grade neutropenia   1/44 (2.27%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils: Conjunctiva   1/44 (2.27%)  1
Infection with high grade neutropenia   1/44 (2.27%)  1
Blood Infection with high grade neutropenia   1/44 (2.27%)  1
Investigations   
Low WBC   3/44 (6.82%)  3
low Platelets   3/44 (6.82%)  3
Low Hemoglobin   8/44 (18.18%)  8
Low ANC   7/44 (15.91%)  7
hyperglycemia   3/44 (6.82%)  3
hypocalcemia   7/44 (15.91%)  7
hypomagnesemia   2/44 (4.55%)  2
hyponatremia   5/44 (11.36%)  5
hypokalemia   7/44 (15.91%)  7
hypoalbuminemia   4/44 (9.09%)  4
serum glutamic pyruvic transaminase   2/44 (4.55%)  2
hypophosphatemia   2/44 (4.55%)  2
serum glutamic oxaloacetic transaminase   2/44 (4.55%)  2
hyperkalemia   1/44 (2.27%)  1
Hypoxia   5/44 (11.36%)  5
Acidosis   1/44 (2.27%)  1
Partial Thromboplastin Time   2/44 (4.55%)  2
Lymphopenia   12/44 (27.27%)  12
Musculoskeletal and connective tissue disorders   
"Muscle weakness, generalized or specific area (not due to neuropathy): Left-sided"   1/44 (2.27%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea   5/44 (11.36%)  5
Pleural effusion (non-malignant)   3/44 (6.82%)  3
Skin and subcutaneous tissue disorders   
Rash/desquamation   7/44 (15.91%)  7
Rash: acne/acneiform   4/44 (9.09%)  4
Rash: dermatitis associated with radiation   1/44 (2.27%)  1
Vascular disorders   
Thrombosis/thrombus/embolism   5/44 (11.36%)  5
Edema: limb   1/44 (2.27%)  1
Hemorrhage Stomach   1/44 (2.27%)  1
Thrombosis/embolism (vascular access-related)   1/44 (2.27%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)
Affected / at Risk (%) # Events
Total   44/44 (100.00%)    
Cardiac disorders   
Hypotension   9/44 (20.45%)  9
Neuropathy: sensory   12/44 (27.27%)  14
Cardiac   44/44 (100.00%)  44
Sinus tachycardia   9/44 (20.45%)  9
Ear and labyrinth disorders   
Auditory/Ear   44/44 (100.00%)  44
Tinnitus   4/44 (9.09%)  4
Neuropathy: cranial: CN VIII Hearing and balance   3/44 (6.82%)  3
Eye disorders   
Ocular/Visual - Other   3/44 (6.82%)  3
Dry eye syndrome   2/44 (4.55%)  2
"Watery eye (epiphora, tearing)"   3/44 (6.82%)  3
blurred vision   2/44 (4.55%)  2
Gastrointestinal disorders   
Nausea   43/44 (97.73%)  43
Vomiting   41/44 (93.18%)  41
Diarrhea   37/44 (84.09%)  37
Constipation   43/44 (97.73%)  43
Hemorrhoids   2/44 (4.55%)  2
General disorders   
Anorexia   38/44 (86.36%)  38
Hair loss   12/44 (27.27%)  12
Hypertension   4/44 (9.09%)  4
Pain (unspecified)   44/44 (100.00%)  44
Dizziness   10/44 (22.73%)  10
Taste alteration   7/44 (15.91%)  7
Insomnia   7/44 (15.91%)  7
Rigors/chills   44/44 (100.00%)  44
Sweating   2/44 (4.55%)  2
Fatigue   41/44 (93.18%)  41
Weight loss   8/44 (18.18%)  8
Pain: Head/headache   9/44 (20.45%)  9
Dysphagia   3/44 (6.82%)  3
Fever without neutropenia   43/44 (97.73%)  43
Edema: trunk/genital   3/44 (6.82%)  3
Heartburn/dyspepsia   6/44 (13.64%)  6
Dry mouth   2/44 (4.55%)  2
Dehydration   7/44 (15.91%)  7
Confusion   4/44 (9.09%)  4
Pruritus/itching   9/44 (20.45%)  9
Mood alteration: Agitation   3/44 (6.82%)  3
Anxiety   6/44 (13.64%)  6
Depression   6/44 (13.64%)  6
Pain: Abdomen   7/44 (15.91%)  7
Pain: Joint   11/44 (25.00%)  13
Arthritis (non-septic)   3/44 (6.82%)  3
Pain: Back   9/44 (20.45%)  9
Pain: Bone   10/44 (22.73%)  12
Pain: Chest/thorax   3/44 (6.82%)  3
Pain: Chest wall   4/44 (9.09%)  4
Neuropathy: cranial: CN VII Motor-face; Sensory-taste   2/44 (4.55%)  2
Memory impairment   2/44 (4.55%)  2
Muscle weakness   9/44 (20.45%)  9
Pain: Muscle   8/44 (18.18%)  8
Nail changes   7/44 (15.91%)  7
Pain: Extremity-limb   3/44 (6.82%)  3
Palpitations   2/44 (4.55%)  2
Pain: Throat/pharynx/larynx   2/44 (4.55%)  2
Pain: Pleura   8/44 (18.18%)  8
Pain: Buttock   2/44 (4.55%)  2
Pain: Tumor pain   4/44 (9.09%)  4
Immune system disorders   
Allergic reaction   42/44 (95.45%)  42
Infections and infestations   
Infection - Other   44/44 (100.00%)  44
Infection with normal ANC or Grade 1 or 2 neutrophils: Bronchus   3/44 (6.82%)  3
Lung infection   3/44 (6.82%)  3
Infection with normal ANC or Grade 1 or 2 neutrophils: Skin (cellulitis)   2/44 (4.55%)  2
Infection with normal ANC or Grade 1 or 2 neutrophils: Vagina   2/44 (4.55%)  2
Mucositis/stomatitis Oral cavity   44/44 (100.00%)  44
Infection with normal ANC or Grade 1 or 2 neutrophils: Conjunctiva   2/44 (4.55%)  2
Injury, poisoning and procedural complications   
Infection with normal ANC or Grade 1 or 2 neutrophils: Nose   2/44 (4.55%)  2
Investigations   
Low WBC   41/44 (93.18%)  41
low Platelets   41/44 (93.18%)  41
Low Hemoglobin   36/44 (81.82%)  36
Alkaline phosphatase   44/44 (100.00%)  44
Creatinine   44/44 (100.00%)  44
Proteinuria   7/44 (15.91%)  7
Low ANC   37/44 (84.09%)  37
hyperglycemia   28/44 (63.64%)  28
hypoglycemia   4/44 (9.09%)  4
hypercalcemia   44/44 (100.00%)  44
hypocalcemia   37/44 (84.09%)  37
hypomagnesemia   17/44 (38.64%)  17
hyponatremia   39/44 (88.64%)  39
hypokalemia   36/44 (81.82%)  36
Bicarbonate serum-low   44/44 (100.00%)  44
hypoalbuminemia   40/44 (90.91%)  40
hyperbilirubinemia   44/44 (100.00%)  44
serum glutamic pyruvic transaminase   10/44 (22.73%)  10
hypophosphatemia   4/44 (9.09%)  4
serum glutamic oxaloacetic transaminase   42/44 (95.45%)  42
hyperkalemia   43/44 (97.73%)  43
hypernatremia   44/44 (100.00%)  44
Acidosis   3/44 (6.82%)  3
Partial Thromboplastin Time   4/44 (9.09%)  4
Alkalosis   2/44 (4.55%)  2
Glomerular filtration rate   2/44 (4.55%)  2
Lymphopenia   19/44 (43.18%)  19
Musculoskeletal and connective tissue disorders   
"Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower"   2/44 (4.55%)  2
Nervous system disorders   
Neuropathy: motor   4/44 (9.09%)  4
Neurology   44/44 (100.00%)  44
Seizure   2/44 (4.55%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea   21/44 (47.73%)  21
Pleural effusion (non-malignant)   4/44 (9.09%)  4
Pulmonary/Upper Respiratory   44/44 (100.00%)  44
Cough   27/44 (61.36%)  27
Atelectasis   7/44 (15.91%)  7
Bronchospasm wheezing   4/44 (9.09%)  4
Pneumothorax   2/44 (4.55%)  2
Skin and subcutaneous tissue disorders   
Dermatology/Skin   44/44 (100.00%)  45
Rash/desquamation   8/44 (18.18%)  8
Rash: acne/acneiform   9/44 (20.45%)  9
Dry skin   15/44 (34.09%)  15
Rash: hand-foot skin reaction   4/44 (9.09%)  4
Rash: dermatitis associated with radiation: Chemoradiation   2/44 (4.55%)  2
Allergic rhinitis   8/44 (18.18%)  8
Vascular disorders   
Thrombosis/thrombus/embolism   2/44 (4.55%)  2
Phlebitis   3/44 (6.82%)  3
Edema: head and neck   2/44 (4.55%)  2
Edema: limb   10/44 (22.73%)  12
Hemorrhage respiratory   8/44 (18.18%)  8
Hemorrhage GI: Oral cavity   2/44 (4.55%)  2
Hemorrhage pulmonary/upper respiratory   6/44 (13.64%)  6
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. William J. Petty
Organization: Wake Forest Baptist Health
Phone: 336-716-3313
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01557959     History of Changes
Obsolete Identifiers: NCT00723138
Other Study ID Numbers: CCCWFU 62107
NCI-2009-01252 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: February 14, 2012
First Posted: March 20, 2012
Results First Submitted: May 1, 2013
Results First Posted: June 28, 2013
Last Update Posted: June 29, 2018