Trial Outcomes & Findings for Weekly Carboplatin, Paclitaxel and Cetuximab Treatment for Patients With Recurrent or Metastatic SCCHN (NCT NCT02124707)
NCT ID: NCT02124707
Last Updated: 2020-08-12
Results Overview
Overall survival after treatment with weekly carboplatin, paclitaxel and cetuximab for 6 weeks with or without the addition of maintenance weekly cetuximab is defined as the time from D1 of treatment under this protocol until death as a result of any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
36 months
Results posted on
2020-08-12
Participant Flow
Subjects were recruited from the University of North Carolina at Chapel Hill Hospitals and Bon Secours Virginia Health System June 16, 2014 to February 27, 2017
Nineteen subjects were consented to this trial. Of these, 3 were not eligible, 2 withdrew before treatment. 14 subjects were treated.
Participant milestones
| Measure |
Carboplatin, Paclitaxel and Cetuximab
A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.
Cetuximab: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue at the 250mg/m2 dose until disease progression.
Paclitaxel: 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.
Carboplatin: Squared Area under the curve (AUC2), IV (in the vein) on day 1 of each 1 week for 6 week
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Carboplatin, Paclitaxel and Cetuximab
A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.
Cetuximab: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue at the 250mg/m2 dose until disease progression.
Paclitaxel: 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.
Carboplatin: Squared Area under the curve (AUC2), IV (in the vein) on day 1 of each 1 week for 6 week
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Weekly Carboplatin, Paclitaxel and Cetuximab Treatment for Patients With Recurrent or Metastatic SCCHN
Baseline characteristics by cohort
| Measure |
Carboplatin, Paclitaxel and Cetuximab
n=14 Participants
A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.
Cetuximab: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue at the 250mg/m2 dose until disease progression.
Paclitaxel: 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.
Carboplatin: AUC2, IV (in the vein) on day 1 of each 1 week for 6 week
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
|
Primary Tumor Site
Glottis
|
1 Participants
n=5 Participants
|
|
Primary Tumor Site
Hypopharynx
|
1 Participants
n=5 Participants
|
|
Primary Tumor Site
Lymph Nodes
|
1 Participants
n=5 Participants
|
|
Primary Tumor Site
Oral Cavity
|
7 Participants
n=5 Participants
|
|
Primary Tumor Site
Ororpharynx
|
4 Participants
n=5 Participants
|
|
T Stage
Tx
|
2 Participants
n=5 Participants
|
|
T Stage
T1
|
1 Participants
n=5 Participants
|
|
T Stage
T2
|
5 Participants
n=5 Participants
|
|
T Stage
T3
|
2 Participants
n=5 Participants
|
|
T Stage
T4a
|
4 Participants
n=5 Participants
|
|
N Stage
N0
|
3 Participants
n=5 Participants
|
|
N Stage
N1
|
1 Participants
n=5 Participants
|
|
N Stage
N2b
|
8 Participants
n=5 Participants
|
|
N Stage
Nx
|
1 Participants
n=5 Participants
|
|
N Stage
Not reported
|
1 Participants
n=5 Participants
|
|
M Stage
M0
|
8 Participants
n=5 Participants
|
|
M Stage
M1
|
6 Participants
n=5 Participants
|
|
human papillomavirus (HPV) infection status
Negative
|
4 Participants
n=5 Participants
|
|
human papillomavirus (HPV) infection status
Positive
|
5 Participants
n=5 Participants
|
|
human papillomavirus (HPV) infection status
Unknown
|
5 Participants
n=5 Participants
|
|
P16
Negative
|
5 Participants
n=5 Participants
|
|
P16
Positive
|
5 Participants
n=5 Participants
|
|
P16
Unknown
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Two patients who received treatment were not analyzed after they withdrew from the study.
Overall survival after treatment with weekly carboplatin, paclitaxel and cetuximab for 6 weeks with or without the addition of maintenance weekly cetuximab is defined as the time from D1 of treatment under this protocol until death as a result of any cause.
Outcome measures
| Measure |
Carboplatin, Paclitaxel and Cetuximab
n=12 Participants
A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic SCCHN. Once protocol therapy is complete, cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.
Cetuximab: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue on maintenance therapy at the 250mg/m2 dose until disease progression.
Paclitaxel: 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.
Carboplatin: AUC2, IV (in the vein) on day 1 of each 1 week for 6 week
|
|---|---|
|
Median Overall Survival
|
231 Days
Interval 89.0 to 700.0
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Two patients who received treatment were not analyzed after they withdrew from the study.
Progression events will be defined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Progression free survival after treatment with weekly carboplatin, paclitaxel and cetuximab for 6 weeks with or without the addition of maintenance weekly cetuximab is defined as the time from Day 1 of treatment until progression or death as a result of any cause.
Outcome measures
| Measure |
Carboplatin, Paclitaxel and Cetuximab
n=12 Participants
A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic SCCHN. Once protocol therapy is complete, cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.
Cetuximab: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue on maintenance therapy at the 250mg/m2 dose until disease progression.
Paclitaxel: 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.
Carboplatin: AUC2, IV (in the vein) on day 1 of each 1 week for 6 week
|
|---|---|
|
Median Progression Free Survival
|
132 Days
Interval 89.0 to 392.0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Two patients who received treatment were not analyzed after they withdrew from the study.
Number of complete response (CR) and partial response (PR) after study treatment with weekly carboplatin, paclitaxel, and cetuximab for 6 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: CR is defined as disappearance of all target lesions; and PR as \>=30% decrease in the sum of the longest diameter of target lesions
Outcome measures
| Measure |
Carboplatin, Paclitaxel and Cetuximab
n=12 Participants
A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic SCCHN. Once protocol therapy is complete, cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.
Cetuximab: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue on maintenance therapy at the 250mg/m2 dose until disease progression.
Paclitaxel: 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.
Carboplatin: AUC2, IV (in the vein) on day 1 of each 1 week for 6 week
|
|---|---|
|
Overall Response Rate by Participants
CR
|
1 Participants
|
|
Overall Response Rate by Participants
PR
|
6 Participants
|
|
Overall Response Rate by Participants
Neither CR nor PR
|
5 Participants
|
SECONDARY outcome
Timeframe: 18 weeksGrade 3 and 4 toxicities associated with this combined chemotherapy regimen as assessed by clinician assessment using the NCI Common Terminology Criteria for Adverse Events,a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Activities of daily living (ADL). Grade 4 Life-threatening consequences; urgent intervention indicated. Describe patient reported symptoms associated with this regimen.
Outcome measures
| Measure |
Carboplatin, Paclitaxel and Cetuximab
n=14 Participants
A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic SCCHN. Once protocol therapy is complete, cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.
Cetuximab: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue on maintenance therapy at the 250mg/m2 dose until disease progression.
Paclitaxel: 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.
Carboplatin: AUC2, IV (in the vein) on day 1 of each 1 week for 6 week
|
|---|---|
|
Incidence of Adverse Events
Infusion Related Reaction
|
1 incidents
|
|
Incidence of Adverse Events
Lymphocyte Count Decreased
|
3 incidents
|
|
Incidence of Adverse Events
Neutrophil Count Decreased
|
6 incidents
|
|
Incidence of Adverse Events
Platelet Count Decreased
|
1 incidents
|
|
Incidence of Adverse Events
Hypernatremia
|
1 incidents
|
|
Incidence of Adverse Events
Hypoalbuminemia
|
1 incidents
|
|
Incidence of Adverse Events
Myalgia
|
1 incidents
|
|
Incidence of Adverse Events
Pneumothorax
|
1 incidents
|
|
Incidence of Adverse Events
Dry Skin
|
1 incidents
|
|
Incidence of Adverse Events
Small Intestinal Obstruction
|
1 incidents
|
|
Incidence of Adverse Events
Fatigue
|
2 incidents
|
|
Incidence of Adverse Events
Gait Disturbance
|
1 incidents
|
|
Incidence of Adverse Events
Sepsis
|
1 incidents
|
|
Incidence of Adverse Events
White Blood Cell Decreased
|
7 incidents
|
|
Incidence of Adverse Events
Hypomagnesemia
|
1 incidents
|
|
Incidence of Adverse Events
Rash Acneiform
|
5 incidents
|
SECONDARY outcome
Timeframe: Baseline, End of treatment (EOT), First follow-up visit (8-12 weeks after EOT)Population: Two patients who received treatment did not complete the measures at any timepoint.
Quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) questionnaire. The FACT-HN is the FACT-General (FACT-G) and a head and neck cancer specific, 12 item subscale given at baseline, at end of treatment, and at first follow-up visit. The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4, with all subscales summed to give a total score with a range of 0-148 Higher scores represent better QOL.
Outcome measures
| Measure |
Carboplatin, Paclitaxel and Cetuximab
n=12 Participants
A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic SCCHN. Once protocol therapy is complete, cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.
Cetuximab: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue on maintenance therapy at the 250mg/m2 dose until disease progression.
Paclitaxel: 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.
Carboplatin: AUC2, IV (in the vein) on day 1 of each 1 week for 6 week
|
|---|---|
|
Head and Neck Quality of Life Assessments
QOL at First Follow-up
|
88 score on a scale
Interval 63.0 to 121.0
|
|
Head and Neck Quality of Life Assessments
QOL at Baseline
|
92.5 score on a scale
Interval 63.0 to 129.0
|
|
Head and Neck Quality of Life Assessments
QOL at End of Treatment
|
87 score on a scale
Interval 64.0 to 113.0
|
Adverse Events
Carboplatin, Paclitaxel and Cetuximab
Serious events: 6 serious events
Other events: 14 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Carboplatin, Paclitaxel and Cetuximab
n=14 participants at risk
A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic SCCHN. Once protocol therapy is complete, cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.
Cetuximab: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue on maintenance therapy at the 250mg/m2 dose until disease progression.
Paclitaxel: 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.
Carboplatin: AUC2, IV (in the vein) on day 1 of each 1 week for 6 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
1/14 • 9 weeks
|
|
Gastrointestinal disorders
Colonic obstruction
|
7.1%
1/14 • 9 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
7.1%
1/14 • 9 weeks
|
|
General disorders
Death NOS
|
7.1%
1/14 • 9 weeks
|
|
General disorders
Infusion related reaction
|
7.1%
1/14 • 9 weeks
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.1%
1/14 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
7.1%
1/14 • 9 weeks
|
Other adverse events
| Measure |
Carboplatin, Paclitaxel and Cetuximab
n=14 participants at risk
A 6 week course of weekly carboplatin, paclitaxel, and cetuximab will be administered to 38 patients with recurrent or metastatic SCCHN. Once protocol therapy is complete, cetuximab may be continued if the patient and physician agree. Within 3 weeks of the end of protocol therapy, response will be assessed, and if the patient has achieved at least stable disease, the treating physician may continue to treat with weekly cetuximab at their discretion until disease progression. Patients will be followed for a maximum of 3 years after the end of the 6 week treatment phase.
Cetuximab: 400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue on maintenance therapy at the 250mg/m2 dose until disease progression.
Paclitaxel: 135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.
Carboplatin: AUC2, IV (in the vein) on day 1 of each 1 week for 6 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
1/14 • 9 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • 9 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
1/14 • 9 weeks
|
|
Psychiatric disorders
Agitation
|
7.1%
1/14 • 9 weeks
|
|
Investigations
Alanine aminotransferase incre
|
14.3%
2/14 • 9 weeks
|
|
Investigations
Alkaline phosphatase increased
|
35.7%
5/14 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
1/14 • 9 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
78.6%
11/14 • 9 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
2/14 • 9 weeks
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • 9 weeks
|
|
Investigations
Aspartate aminotransferase inc
|
7.1%
1/14 • 9 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
1/14 • 9 weeks
|
|
Infections and infestations
Catheter related infection
|
7.1%
1/14 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.1%
1/14 • 9 weeks
|
|
General disorders
Chills
|
14.3%
2/14 • 9 weeks
|
|
Psychiatric disorders
Confusion
|
7.1%
1/14 • 9 weeks
|
|
Eye disorders
Conjunctivitis
|
7.1%
1/14 • 9 weeks
|
|
Gastrointestinal disorders
Constipation
|
28.6%
4/14 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
3/14 • 9 weeks
|
|
Investigations
Creatinine increased
|
14.3%
2/14 • 9 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
21.4%
3/14 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
1/14 • 9 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • 9 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
1/14 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
1/14 • 9 weeks
|
|
General disorders
Edema limbs
|
7.1%
1/14 • 9 weeks
|
|
Infections and infestations
Enterocolitis infectious
|
14.3%
2/14 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
1/14 • 9 weeks
|
|
General disorders
Fatigue
|
42.9%
6/14 • 9 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
1/14 • 9 weeks
|
|
General disorders
Fever
|
21.4%
3/14 • 9 weeks
|
|
General disorders
Gait disturbance
|
7.1%
1/14 • 9 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders - O
|
7.1%
1/14 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
1/14 • 9 weeks
|
|
Psychiatric disorders
Hallucinations
|
7.1%
1/14 • 9 weeks
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.1%
1/14 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.1%
1/14 • 9 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.4%
3/14 • 9 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
2/14 • 9 weeks
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
14.3%
2/14 • 9 weeks
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.1%
1/14 • 9 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
42.9%
6/14 • 9 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.6%
4/14 • 9 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.4%
3/14 • 9 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
35.7%
5/14 • 9 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
35.7%
5/14 • 9 weeks
|
|
General disorders
Infusion related reaction
|
7.1%
1/14 • 9 weeks
|
|
Psychiatric disorders
Insomnia
|
14.3%
2/14 • 9 weeks
|
|
Psychiatric disorders
Libido decreased
|
7.1%
1/14 • 9 weeks
|
|
General disorders
Localized edema
|
7.1%
1/14 • 9 weeks
|
|
Vascular disorders
Lymphedema
|
14.3%
2/14 • 9 weeks
|
|
Investigations
Lymphocyte count decreased
|
50.0%
7/14 • 9 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
2/14 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
2/14 • 9 weeks
|
|
Gastrointestinal disorders
Nausea
|
42.9%
6/14 • 9 weeks
|
|
Investigations
Neutrophil count decreased
|
71.4%
10/14 • 9 weeks
|
|
Gastrointestinal disorders
Obstruction gastric
|
7.1%
1/14 • 9 weeks
|
|
Gastrointestinal disorders
Oral pain
|
7.1%
1/14 • 9 weeks
|
|
General disorders
Pain
|
21.4%
3/14 • 9 weeks
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.1%
1/14 • 9 weeks
|
|
Investigations
Platelet count decreased
|
35.7%
5/14 • 9 weeks
|
|
Gastrointestinal disorders
Proctitis
|
7.1%
1/14 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
71.4%
10/14 • 9 weeks
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • 9 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
7.1%
1/14 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue d
|
7.1%
1/14 • 9 weeks
|
|
Infections and infestations
Skin infection
|
7.1%
1/14 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.1%
1/14 • 9 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
7.1%
1/14 • 9 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
14.3%
2/14 • 9 weeks
|
|
Renal and urinary disorders
Urinary frequency
|
7.1%
1/14 • 9 weeks
|
|
Renal and urinary disorders
Urinary retention
|
7.1%
1/14 • 9 weeks
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • 9 weeks
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • 9 weeks
|
|
Investigations
Weight loss
|
21.4%
3/14 • 9 weeks
|
|
Investigations
White blood cell decreased
|
85.7%
12/14 • 9 weeks
|
Additional Information
Robin Johnson
UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place