Trial Outcomes & Findings for Docetaxel, Cisplatin, Pegfilgrastim, and Erlotinib Hydrochloride in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NCT NCT01557959)

NCT ID: NCT01557959

Last Updated: 2018-06-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 45 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2018-06-29

Participant Flow

Participant milestones

Measure	Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy) 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 Study STARTED	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy) n=45 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	58.6 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

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.

Outcome measures

Measure	Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy) n=45 Participants 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.	High Cyclin D1
Time to Progression	4.63 months Interval 3.68 to 6.05	—

SECONDARY outcome

Timeframe: 2 years

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".

Outcome measures

Measure	Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy) n=16 Participants 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.	High Cyclin D1 n=15 Participants
Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood Progressive disease	3 Participants	4 Participants
Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood Stable disease	9 Participants	9 Participants
Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood Partial response	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy) n=16 Participants 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.	High Cyclin D1 n=15 Participants
Median Survival Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood	20.5 Months Standard Error 7.7	8.0 Months Standard Error 10.7

Adverse Events

Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)

Serious events: 39 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy) n=44 participants at risk 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.
Investigations Low WBC	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations low Platelets	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Low Hemoglobin	18.2% 8/44 • Number of events 8 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Gastrointestinal disorders Nausea	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Gastrointestinal disorders Vomiting	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Gastrointestinal disorders Diarrhea	15.9% 7/44 • Number of events 7 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Anorexia	13.6% 6/44 • Number of events 6 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.4% 5/44 • Number of events 5 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Cardiac disorders Hypotension	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Low ANC	15.9% 7/44 • Number of events 7 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Dizziness	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Insomnia	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Fatigue	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Weight loss	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hyperglycemia	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hypocalcemia	15.9% 7/44 • Number of events 7 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hypomagnesemia	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hyponatremia	11.4% 5/44 • Number of events 5 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hypokalemia	15.9% 7/44 • Number of events 7 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hypoalbuminemia	9.1% 4/44 • Number of events 4 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations serum glutamic pyruvic transaminase	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hypophosphatemia	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Gastrointestinal disorders Constipation	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Vascular disorders Thrombosis/thrombus/embolism	11.4% 5/44 • Number of events 5 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations serum glutamic oxaloacetic transaminase	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hyperkalemia	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Eye disorders Ocular/Visual - Other	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Dysphagia	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Fever without neutropenia	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Urinary frequency/urgency	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Vascular disorders Edema: limb	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Hypoxia	11.4% 5/44 • Number of events 5 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Dehydration	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Confusion	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Skin and subcutaneous tissue disorders Rash/desquamation	15.9% 7/44 • Number of events 7 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Acidosis	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	9.1% 4/44 • Number of events 4 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Partial Thromboplastin Time	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Joint	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Arthritis (non-septic)	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Cardiac disorders Atrial fibrillation	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Bone	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Chest wall	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Blood and lymphatic system disorders "Hemorrhage, GI: Duodenum"	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Vascular disorders Hemorrhage Stomach	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Blood and lymphatic system disorders "Hemorrhage, CNS"	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Ear and labyrinth disorders Hearing: patients without baseline audiogram and not enrolled in a monitoring program	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Immune system disorders Allergic reaction	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Infections and infestations Flu-like syndrome	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Lymphopenia	27.3% 12/44 • Number of events 12 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Muscle weakness	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Nail changes	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders "Stricture/stenosis (including anastomotic), GI: Esophagus"	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Extremity-limb	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain (unspecified)	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Pleura	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Infections and infestations Lung infection	13.6% 6/44 • Number of events 6 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Blood and lymphatic system disorders "Hemorrhage, GI: Rectum"	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Blood and lymphatic system disorders "Hemorrhage, pulmonary/upper respiratory: Respiratory tract NOS"	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Infections and infestations Infection with unknown ANC: Blood	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Syncope (fainting)	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Cardiac disorders Vasovagal episode	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Ear and labyrinth disorders Tinnitus	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Infections and infestations Urinary with low grade neutropenia	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Death not associated with CTCAE term: Disease progression NOS	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Vascular disorders Thrombosis/embolism (vascular access-related)	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Tumor pain	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Conjunctiva	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Musculoskeletal and connective tissue disorders "Muscle weakness, generalized or specific area (not due to neuropathy): Left-sided"	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: External ear	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Infections and infestations Infection with high grade neutropenia	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Infections and infestations Blood Infection with high grade neutropenia	2.3% 1/44 • Number of events 1 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.

Other adverse events

Measure	Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy) n=44 participants at risk 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.
Investigations Low WBC	93.2% 41/44 • Number of events 41 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations low Platelets	93.2% 41/44 • Number of events 41 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Low Hemoglobin	81.8% 36/44 • Number of events 36 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Gastrointestinal disorders Nausea	97.7% 43/44 • Number of events 43 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Gastrointestinal disorders Vomiting	93.2% 41/44 • Number of events 41 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Gastrointestinal disorders Diarrhea	84.1% 37/44 • Number of events 37 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Anorexia	86.4% 38/44 • Number of events 38 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Alkaline phosphatase	100.0% 44/44 • Number of events 44 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Creatinine	100.0% 44/44 • Number of events 44 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Proteinuria	15.9% 7/44 • Number of events 7 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Hair loss	27.3% 12/44 • Number of events 12 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Respiratory, thoracic and mediastinal disorders Dyspnea	47.7% 21/44 • Number of events 21 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	9.1% 4/44 • Number of events 4 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory	100.0% 44/44 • Number of events 44 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Hypertension	9.1% 4/44 • Number of events 4 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Cardiac disorders Hypotension	20.5% 9/44 • Number of events 9 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Cardiac disorders Neuropathy: sensory	27.3% 12/44 • Number of events 14 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Nervous system disorders Neuropathy: motor	9.1% 4/44 • Number of events 4 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Low ANC	84.1% 37/44 • Number of events 37 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain (unspecified)	100.0% 44/44 • Number of events 44 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Dizziness	22.7% 10/44 • Number of events 10 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Taste alteration	15.9% 7/44 • Number of events 7 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Insomnia	15.9% 7/44 • Number of events 7 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Nervous system disorders Neurology	100.0% 44/44 • Number of events 44 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Skin and subcutaneous tissue disorders Dermatology/Skin	100.0% 44/44 • Number of events 45 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Rigors/chills	100.0% 44/44 • Number of events 44 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Sweating	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Fatigue	93.2% 41/44 • Number of events 41 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Weight loss	18.2% 8/44 • Number of events 8 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hyperglycemia	63.6% 28/44 • Number of events 28 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hypoglycemia	9.1% 4/44 • Number of events 4 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hypercalcemia	100.0% 44/44 • Number of events 44 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hypocalcemia	84.1% 37/44 • Number of events 37 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hypomagnesemia	38.6% 17/44 • Number of events 17 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hyponatremia	88.6% 39/44 • Number of events 39 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hypokalemia	81.8% 36/44 • Number of events 36 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Bicarbonate serum-low	100.0% 44/44 • Number of events 44 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hypoalbuminemia	90.9% 40/44 • Number of events 40 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hyperbilirubinemia	100.0% 44/44 • Number of events 44 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations serum glutamic pyruvic transaminase	22.7% 10/44 • Number of events 10 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hypophosphatemia	9.1% 4/44 • Number of events 4 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Gastrointestinal disorders Constipation	97.7% 43/44 • Number of events 43 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Head/headache	20.5% 9/44 • Number of events 9 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Vascular disorders Thrombosis/thrombus/embolism	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations serum glutamic oxaloacetic transaminase	95.5% 42/44 • Number of events 42 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hyperkalemia	97.7% 43/44 • Number of events 43 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations hypernatremia	100.0% 44/44 • Number of events 44 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Vascular disorders Phlebitis	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Eye disorders Ocular/Visual - Other	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Dysphagia	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Fever without neutropenia	97.7% 43/44 • Number of events 43 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Cardiac disorders Cardiac	100.0% 44/44 • Number of events 44 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Infections and infestations Infection - Other	100.0% 44/44 • Number of events 44 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Respiratory, thoracic and mediastinal disorders Cough	61.4% 27/44 • Number of events 27 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Ear and labyrinth disorders Auditory/Ear	100.0% 44/44 • Number of events 44 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Vascular disorders Edema: head and neck	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Vascular disorders Edema: limb	22.7% 10/44 • Number of events 12 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Edema: trunk/genital	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Heartburn/dyspepsia	13.6% 6/44 • Number of events 6 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Dry mouth	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Dehydration	15.9% 7/44 • Number of events 7 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Confusion	9.1% 4/44 • Number of events 4 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pruritus/itching	20.5% 9/44 • Number of events 9 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Mood alteration: Agitation	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Anxiety	13.6% 6/44 • Number of events 6 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Depression	13.6% 6/44 • Number of events 6 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Skin and subcutaneous tissue disorders Rash/desquamation	18.2% 8/44 • Number of events 8 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Abdomen	15.9% 7/44 • Number of events 7 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Acidosis	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	20.5% 9/44 • Number of events 9 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Partial Thromboplastin Time	9.1% 4/44 • Number of events 4 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Alkalosis	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Joint	25.0% 11/44 • Number of events 13 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Arthritis (non-septic)	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Respiratory, thoracic and mediastinal disorders Atelectasis	15.9% 7/44 • Number of events 7 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Back	20.5% 9/44 • Number of events 9 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Bone	22.7% 10/44 • Number of events 12 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Bronchus	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Respiratory, thoracic and mediastinal disorders Bronchospasm wheezing	9.1% 4/44 • Number of events 4 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Chest/thorax	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Chest wall	9.1% 4/44 • Number of events 4 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Nervous system disorders Seizure	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Eye disorders Dry eye syndrome	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Skin and subcutaneous tissue disorders Dry skin	34.1% 15/44 • Number of events 15 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Vascular disorders Hemorrhage respiratory	18.2% 8/44 • Number of events 8 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Neuropathy: cranial: CN VII Motor-face; Sensory-taste	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Glomerular filtration rate	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Gastrointestinal disorders Hemorrhoids	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Immune system disorders Allergic reaction	95.5% 42/44 • Number of events 42 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Eye disorders "Watery eye (epiphora, tearing)"	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	9.1% 4/44 • Number of events 4 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Investigations Lymphopenia	43.2% 19/44 • Number of events 19 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Memory impairment	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Vascular disorders Hemorrhage GI: Oral cavity	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Muscle weakness	20.5% 9/44 • Number of events 9 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Muscle	18.2% 8/44 • Number of events 8 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Nail changes	15.9% 7/44 • Number of events 7 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Extremity-limb	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Palpitations	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Throat/pharynx/larynx	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Pleura	18.2% 8/44 • Number of events 8 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Infections and infestations Lung infection	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Respiratory, thoracic and mediastinal disorders Pneumothorax	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation: Chemoradiation	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Skin and subcutaneous tissue disorders Allergic rhinitis	18.2% 8/44 • Number of events 8 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Cardiac disorders Sinus tachycardia	20.5% 9/44 • Number of events 9 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Skin (cellulitis)	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Ear and labyrinth disorders Tinnitus	9.1% 4/44 • Number of events 4 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Vagina	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Eye disorders blurred vision	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Buttock	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
General disorders Pain: Tumor pain	9.1% 4/44 • Number of events 4 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Injury, poisoning and procedural complications Infection with normal ANC or Grade 1 or 2 neutrophils: Nose	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Infections and infestations Mucositis/stomatitis Oral cavity	100.0% 44/44 • Number of events 44 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Vascular disorders Hemorrhage pulmonary/upper respiratory	13.6% 6/44 • Number of events 6 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils: Conjunctiva	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Musculoskeletal and connective tissue disorders "Muscle weakness, generalized or specific area (not due to neuropathy): Extremity-lower"	4.5% 2/44 • Number of events 2 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.
Ear and labyrinth disorders Neuropathy: cranial: CN VIII Hearing and balance	6.8% 3/44 • Number of events 3 44 of the 45 patients had completed therapy at the time of reporting. Adverse events reflect those 44 patients.

Additional Information

Dr. William J. Petty

Wake Forest Baptist Health

Phone: 336-716-3313

Email: wpetty@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place