Trial Outcomes & Findings for Combination Chemotherapy, Bev, RT, and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer (NCT NCT00280150)
NCT ID: NCT00280150
Last Updated: 2017-06-19
Results Overview
Dose-limiting toxicities (DLTs) were used to establish which cohort would be used for the phase II portion of the trial. DLTs were defined as any grade 3 or 4 nonhematologic toxicity with the exception of esophagitis, which had to be grade 4; grade 4 neutropenia lasting greater than or equal to 7 days and thrombocytopenia to less than 20,000/microliter.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
46 participants
Primary outcome timeframe
6 weeks after completion of therapy
Results posted on
2017-06-19
Participant Flow
Participants were recruited from four institutions between February 2006 and April 2010.
Of the 48 participants screened for eligibility, 46 were deemed eligible and went on to treatment, 1 was ineligible, and 1 was initially ruled eligible but the liver functioning tests (LFTs) continued to increase so the PI felt the participant should not be treated.
Participant milestones
| Measure |
Cohort 1
Bevacizumab 10 mg + Chemoradiotherapy
|
Cohort 2
Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy
|
Cohort 3
Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy
|
Phase II
Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
6
|
30
|
|
Overall Study
Cohort Induction
|
5
|
5
|
6
|
30
|
|
Overall Study
Consolidation Therapy
|
2
|
5
|
3
|
0
|
|
Overall Study
COMPLETED
|
2
|
4
|
1
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
5
|
10
|
Reasons for withdrawal
| Measure |
Cohort 1
Bevacizumab 10 mg + Chemoradiotherapy
|
Cohort 2
Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy
|
Cohort 3
Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy
|
Phase II
Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
3
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
Did not get consolidation therapy
|
3
|
0
|
3
|
0
|
|
Overall Study
Declining Performance Status
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Combination Chemotherapy, Bev, RT, and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1
n=5 Participants
Bevacizumab 10 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
|
Cohort 2
n=5 Participants
Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
|
Cohort 3
n=6 Participants
Bevacizumab + Erlotinib 150 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
|
Phase II
n=30 Participants
Bevacizumab + Erlotinib100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
18 Participants
n=31 Participants
|
28 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
12 Participants
n=31 Participants
|
18 Participants
n=146 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
16 Participants
n=31 Participants
|
22 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
14 Participants
n=31 Participants
|
24 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
29 Participants
n=31 Participants
|
45 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
10 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
22 Participants
n=31 Participants
|
34 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=39 Participants
|
5 participants
n=41 Participants
|
6 participants
n=35 Participants
|
30 participants
n=31 Participants
|
46 participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after completion of therapyPopulation: This was a phase I objective only, so the phase II participants are not included.
Dose-limiting toxicities (DLTs) were used to establish which cohort would be used for the phase II portion of the trial. DLTs were defined as any grade 3 or 4 nonhematologic toxicity with the exception of esophagitis, which had to be grade 4; grade 4 neutropenia lasting greater than or equal to 7 days and thrombocytopenia to less than 20,000/microliter.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Bevacizumab 10 mg + Chemoradiotherapy
|
Cohort 2
n=5 Participants
Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy
|
Cohort 3
n=6 Participants
Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy
|
Phase II
Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy
|
|---|---|---|---|---|
|
Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008])
|
0 DLTs
|
0 DLTs
|
2 DLTs
|
—
|
PRIMARY outcome
Timeframe: 6 weeks after completion of therapyPopulation: Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable for toxicity. 42 patients were eligible for concurrent therapy.
A list of Hematologic and nonhematologic toxicities associated with induction and concurrent therapy. This includes the percentage of patients who experienced grades 2-4 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0).
Outcome measures
| Measure |
Cohort 1
n=45 Participants
Bevacizumab 10 mg + Chemoradiotherapy
|
Cohort 2
n=42 Participants
Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy
|
Cohort 3
Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy
|
Phase II
Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy
|
|---|---|---|---|---|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Anemia
|
4 percentage of participants
|
17 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Neutrophenia
|
52 percentage of participants
|
35 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Thrombocytopenia
|
0 percentage of participants
|
16 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Febrile neutropenia
|
0 percentage of participants
|
2 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Nausea/vomiting
|
7 percentage of participants
|
6 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Fatigue
|
20 percentage of participants
|
22 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Alopecia
|
42 percentage of participants
|
9 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Myalgias/arthralgias
|
27 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Diarrhea
|
6 percentage of participants
|
2 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Neuropathy
|
2 percentage of participants
|
2 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Rash
|
2 percentage of participants
|
11 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Anorexia
|
0 percentage of participants
|
6 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Hypomagnesemia
|
0 percentage of participants
|
4 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Proteinuria
|
0 percentage of participants
|
2 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Weight loss
|
0 percentage of participants
|
9 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Pneumonitis
|
0 percentage of participants
|
2 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Hypersensitivity reaction
|
4 percentage of participants
|
2 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Hypertension
|
9 percentage of participants
|
4 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Esophagitis
|
0 percentage of participants
|
40 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Dehydration
|
0 percentage of participants
|
11 percentage of participants
|
—
|
—
|
|
Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy
Hemorrhage
|
0 percentage of participants
|
6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients.
The length of time during and after the treatment of a stage IIIA/B NSCLC that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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.
Outcome measures
| Measure |
Cohort 1
n=45 Participants
Bevacizumab 10 mg + Chemoradiotherapy
|
Cohort 2
Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy
|
Cohort 3
Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy
|
Phase II
Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
10.2 Months
Interval 8.4 to 18.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 43 of 45 patients received both cycles of induction C/P therapy plus bevacizumab.
Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement. The same method of assessment and the same techniques should be used to characterize each identified and reported lesion at baseline and during follow-up. Complete Response (CR)- Disappearance of all target lesions
Outcome measures
| Measure |
Cohort 1
n=43 Participants
Bevacizumab 10 mg + Chemoradiotherapy
|
Cohort 2
Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy
|
Cohort 3
Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy
|
Phase II
Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy
|
|---|---|---|---|---|
|
Response Rate to Induction Therapy (Phase I [Closed to Accrual as of 1/3/2008] and II)
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients.
The overall response rate (ORR) to the two cycles of induction therapy plus bevacizumab in stage IIIA/B NSCLC. ORR is the portion of patients with a tumor size reduction for a minimum time period. Response duration is measured from the time of initial response until documented tumor progression.
Outcome measures
| Measure |
Cohort 1
n=45 Participants
Bevacizumab 10 mg + Chemoradiotherapy
|
Cohort 2
Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy
|
Cohort 3
Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy
|
Phase II
Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy
|
|---|---|---|---|---|
|
Overall Response Rate and Survival Profile
|
39 percentage of participants
Interval 24.0 to 55.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 cyclesPopulation: Of the initial 14 patients, only 9 (64%) patients were able to start consolidation therapy and only 5 (36%) patients were able to complete 6 cycles.
The proportion of patients who were able to complete consolidation therapy after induction therapy and chemoradiotherapy
Outcome measures
| Measure |
Cohort 1
n=14 Participants
Bevacizumab 10 mg + Chemoradiotherapy
|
Cohort 2
Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy
|
Cohort 3
Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy
|
Phase II
Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy
|
|---|---|---|---|---|
|
Feasibility and Tolerability of Administering Consolidation Therapy
|
5 Participants
|
—
|
—
|
—
|
Adverse Events
Overall Study
Serious events: 19 serious events
Other events: 45 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Overall Study
n=45 participants at risk
Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients. This includes patients from all cohorts.
|
|---|---|
|
Gastrointestinal disorders
Esophagitis
|
11.1%
5/45 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Bronchus
|
2.2%
1/45 • 5 years
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (Specify, __)
|
2.2%
1/45 • 5 years
|
|
General disorders
Pain - Chest/thorax NOS
|
2.2%
1/45 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
4.4%
2/45 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/45 • 5 years
|
|
Nervous system disorders
Dizziness
|
2.2%
1/45 • 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
4.4%
2/45 • 5 years
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
2.2%
1/45 • 5 years
|
|
Infections and infestations
Infection with unknown ANC - Esophagus
|
4.4%
2/45 • 5 years
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
2.2%
1/45 • 5 years
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
2.2%
1/45 • 5 years
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 Lymphopenia
|
2.2%
1/45 • 5 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
2.2%
1/45 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
2.2%
1/45 • 5 years
|
|
Renal and urinary disorders
Renal failure
|
2.2%
1/45 • 5 years
|
|
General disorders
Rigors/chills
|
2.2%
1/45 • 5 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
2.2%
1/45 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45 • 5 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
2.2%
1/45 • 5 years
|
Other adverse events
| Measure |
Overall Study
n=45 participants at risk
Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients. This includes patients from all cohorts.
|
|---|---|
|
Investigations
Alkaline phosphatase
|
4.4%
2/45 • 5 years
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
13.3%
6/45 • 5 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
75.6%
34/45 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
4.4%
2/45 • 5 years
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
4.4%
2/45 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
26.7%
12/45 • 5 years
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
2.2%
1/45 • 5 years
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
2.2%
1/45 • 5 years
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
6.7%
3/45 • 5 years
|
|
Injury, poisoning and procedural complications
Burn
|
2.2%
1/45 • 5 years
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Specify, __)
|
2.2%
1/45 • 5 years
|
|
Nervous system disorders
Cognitive disturbance
|
2.2%
1/45 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
20.0%
9/45 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.8%
8/45 • 5 years
|
|
Investigations
Creatinine
|
8.9%
4/45 • 5 years
|
|
Immune system disorders
Cytokine release syndrome/acute infusion reaction
|
2.2%
1/45 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
13.3%
6/45 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
18/45 • 5 years
|
|
Nervous system disorders
Dizziness
|
17.8%
8/45 • 5 years
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
6.7%
3/45 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.2%
1/45 • 5 years
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
15.6%
7/45 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
13.3%
6/45 • 5 years
|
|
General disorders
Edema: head and neck
|
2.2%
1/45 • 5 years
|
|
General disorders
Edema: limb
|
4.4%
2/45 • 5 years
|
|
Gastrointestinal disorders
Esophagitis
|
60.0%
27/45 • 5 years
|
|
General disorders
Extremity-lower (gait/walking)
|
2.2%
1/45 • 5 years
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
75.6%
34/45 • 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
1/45 • 5 years
|
|
Vascular disorders
Flushing
|
2.2%
1/45 • 5 years
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
2.2%
1/45 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
2.2%
1/45 • 5 years
|
|
Renal and urinary disorders
Glomerular filtration rate
|
4.4%
2/45 • 5 years
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
4.4%
2/45 • 5 years
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
2.2%
1/45 • 5 years
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
77.8%
35/45 • 5 years
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
13.3%
6/45 • 5 years
|
|
Vascular disorders
Hematoma
|
2.2%
1/45 • 5 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
48.9%
22/45 • 5 years
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
11.1%
5/45 • 5 years
|
|
Renal and urinary disorders
Hemorrhage, GU - Bladder
|
2.2%
1/45 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Lung
|
2.2%
1/45 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
28.9%
13/45 • 5 years
|
|
Vascular disorders
Hemorrhage/Bleeding - Other (Specify, __)
|
13.3%
6/45 • 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.2%
1/45 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
2.2%
1/45 • 5 years
|
|
Vascular disorders
Hot flashes/flushes
|
4.4%
2/45 • 5 years
|
|
Vascular disorders
Hypertension
|
22.2%
10/45 • 5 years
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
2.2%
1/45 • 5 years
|
|
Vascular disorders
Hypotension
|
6.7%
3/45 • 5 years
|
|
Infections and infestations
Infection - Other (Specify, __)
|
4.4%
2/45 • 5 years
|
|
Infections and infestations
Infection
|
4.4%
2/45 • 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Foreign body
|
2.2%
1/45 • 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
|
2.2%
1/45 • 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus
|
2.2%
1/45 • 5 years
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
|
2.2%
1/45 • 5 years
|
|
Infections and infestations
Infection with unknown ANC - Esophagus
|
2.2%
1/45 • 5 years
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
2.2%
1/45 • 5 years
|
|
Infections and infestations
Infection with unknown ANC - Sinus
|
4.4%
2/45 • 5 years
|
|
General disorders
Injection site reaction/extravasation changes
|
2.2%
1/45 • 5 years
|
|
Psychiatric disorders
Insomnia
|
8.9%
4/45 • 5 years
|
|
Metabolism and nutrition disorders
Joint-function
|
2.2%
1/45 • 5 years
|
|
Investigations
Leukocytes (total WBC)
|
15.6%
7/45 • 5 years
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
15.6%
7/45 • 5 years
|
|
Investigations
Metabolic/Laboratory - Other (Specify, __)
|
6.7%
3/45 • 5 years
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
2.2%
1/45 • 5 years
|
|
Psychiatric disorders
Mood alteration - Depression
|
2.2%
1/45 • 5 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Esophagus
|
2.2%
1/45 • 5 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
11.1%
5/45 • 5 years
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Esophagus
|
2.2%
1/45 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular
|
15.6%
7/45 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
2.2%
1/45 • 5 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
6.7%
3/45 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
40.0%
18/45 • 5 years
|
|
Nervous system disorders
Neurology - Other (Specify, __)
|
4.4%
2/45 • 5 years
|
|
Nervous system disorders
Neuropathy: motor
|
2.2%
1/45 • 5 years
|
|
Nervous system disorders
Neuropathy: sensory
|
46.7%
21/45 • 5 years
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
4.4%
2/45 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
13.3%
6/45 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
4.4%
2/45 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
2.2%
1/45 • 5 years
|
|
General disorders
Pain - Chest/thorax NOS
|
4.4%
2/45 • 5 years
|
|
Gastrointestinal disorders
Pain - Esophagus
|
2.2%
1/45 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
2.2%
1/45 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
53.3%
24/45 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
33.3%
15/45 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
2.2%
1/45 • 5 years
|
|
Gastrointestinal disorders
Pain - Oral-gums
|
4.4%
2/45 • 5 years
|
|
General disorders
Pain - Other (Specify, __)
|
4.4%
2/45 • 5 years
|
|
General disorders
Pain - Pain NOS
|
4.4%
2/45 • 5 years
|
|
Gastrointestinal disorders
Pain - Rectum
|
2.2%
1/45 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
6.7%
3/45 • 5 years
|
|
Investigations
Platelets
|
44.4%
20/45 • 5 years
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
4.4%
2/45 • 5 years
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
3/45 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
11.1%
5/45 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
8.9%
4/45 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
26.7%
12/45 • 5 years
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated with radiation - Chemoradiation
|
8.9%
4/45 • 5 years
|
|
Injury, poisoning and procedural complications
Rash: dermatitis associated with radiation - Radiation
|
6.7%
3/45 • 5 years
|
|
Renal and urinary disorders
Renal failure
|
2.2%
1/45 • 5 years
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Specify, __)
|
2.2%
1/45 • 5 years
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
2.2%
1/45 • 5 years
|
|
Gastrointestinal disorders
Stricture/stenosis (including anastomotic), GI - Esophagus
|
20.0%
9/45 • 5 years
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
4.4%
2/45 • 5 years
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
11.1%
5/45 • 5 years
|
|
Gastrointestinal disorders
Ulcer, GI - Esophagus
|
15.6%
7/45 • 5 years
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
2.2%
1/45 • 5 years
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
2.2%
1/45 • 5 years
|
|
Reproductive system and breast disorders
Vaginitis (not due to infection)
|
2.2%
1/45 • 5 years
|
|
Eye disorders
Vision-blurred vision
|
4.4%
2/45 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
6.7%
3/45 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
9/45 • 5 years
|
|
Investigations
Weight loss
|
15.6%
7/45 • 5 years
|
|
Nervous system disorders
Mental Status
|
2.2%
1/45 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify,___)
|
2.2%
1/45 • 5 years
|
Additional Information
Robin V. 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
Restriction type: GT60