Trial Outcomes & Findings for Etoposide, Cyclophosphamide, Thalidomide, Celecoxib, and Fenofibrate in Relapsed or Progressive Cancer (NCT NCT00357500)
NCT ID: NCT00357500
Last Updated: 2014-10-01
Results Overview
Proportion of patients alive at 27 weeks without progressive disease (PD) and having tolerated therapy. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as \>/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as \>/=25% or \>/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
27 weeks
Results posted on
2014-10-01
Participant Flow
The study was open for patient accrual at 11 different pediatric oncology centers from January 7, 2005 through March 6, 2009.
Patients must have recovered or stabalized the toxicity from prior therapy.
Participant milestones
| Measure |
5-drug Metronomic Antiangiogenic Regimen
Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: \< 20 kg at 100 mg; 20-50 kg at 200 mg; \> 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
|
|---|---|
|
Overall Study
STARTED
|
101
|
|
Overall Study
Began Protocol Therapy
|
97
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
77
|
Reasons for withdrawal
| Measure |
5-drug Metronomic Antiangiogenic Regimen
Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: \< 20 kg at 100 mg; 20-50 kg at 200 mg; \> 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Progressive Disease
|
65
|
|
Overall Study
Not Started Protocol Therapy
|
4
|
Baseline Characteristics
Etoposide, Cyclophosphamide, Thalidomide, Celecoxib, and Fenofibrate in Relapsed or Progressive Cancer
Baseline characteristics by cohort
| Measure |
5-drug Metronmic Antiangiogenic Regimen
n=97 Participants
Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: \< 20 kg at 100 mg; 20-50 kg at 200 mg; \> 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
|
|---|---|
|
Age, Categorical
<=18 years
|
91 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
10 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=99 Participants
|
|
Disease Group
High Grade Glioma
|
21 participants
n=99 Participants
|
|
Disease Group
Ependymoma
|
19 participants
n=99 Participants
|
|
Disease Group
Low Grade Glioma
|
12 participants
n=99 Participants
|
|
Disease Group
Bone Tumors
|
12 participants
n=99 Participants
|
|
Disease Group
Medulloblastoma/PNET
|
8 participants
n=99 Participants
|
|
Disease Group
Neuroblastoma
|
3 participants
n=99 Participants
|
|
Disease Group
Leukemia/Lymphoma
|
4 participants
n=99 Participants
|
|
Disease Group
Miscellaneous CNS Tumors
|
9 participants
n=99 Participants
|
|
Disease Group
Miscellaneous non-CNS Tumors
|
9 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 27 weeksPopulation: The analysis dataset is comprised of all treated patients.
Proportion of patients alive at 27 weeks without progressive disease (PD) and having tolerated therapy. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as \>/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as \>/=25% or \>/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.
Outcome measures
| Measure |
5-drug Metronomic Antiangiogenic Regimen
n=97 Participants
Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: \< 20 kg at 100 mg; 20-50 kg at 200 mg; \> 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
|
|---|---|
|
Therapy Completion Rate
|
.25 proportion of patients
Interval 0.18 to 0.33
|
SECONDARY outcome
Timeframe: Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.Population: The analysis dataset is comprised of all treated patients.
27-week progression-free survival is the probability of patients remaining alive and progression-free at 27-weeks from study entry estimated using Kaplan-Meier methods. As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Progressive disease was defined as \>/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease. For patients with leukemia PD was defined as \>/=25% or \>/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.
Outcome measures
| Measure |
5-drug Metronomic Antiangiogenic Regimen
n=97 Participants
Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: \< 20 kg at 100 mg; 20-50 kg at 200 mg; \> 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
|
|---|---|
|
27-Week Progression-Free Survival
|
0.31 Probability
Interval 0.21 to 0.42
|
SECONDARY outcome
Timeframe: Assessed every 9 weeks on treatment and annually until death or initiation of new therapy, up to 27 weeks.Population: The analysis dataset is comprised of all treated patients.
27-week overall survival is the probability of patients remaining alive at 27-weeks from study entry estimated using with Kaplan-Meier methods.
Outcome measures
| Measure |
5-drug Metronomic Antiangiogenic Regimen
n=97 Participants
Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: \< 20 kg at 100 mg; 20-50 kg at 200 mg; \> 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
|
|---|---|
|
27-Week Overall Survival
|
0.61 Probability
Interval 0.49 to 0.71
|
SECONDARY outcome
Timeframe: Assessed at study entry, every 9 weeks on treatment and at treatment discontinuation, up to 27 weeks.As appropriate for tumor type and location, gadolinium-enhanced MRI and other imaging modalites were used to assess response. Best response was regarded as best response at any single assessment. Response was defined as follows: complete resolution of all demonstrable tumor, complete response (CR); \>/=50% decrease in the product of the 2 maximum perpendicular diameters relative to the baseline evaluation, partial response (PR); \<50% decrease and \<25% increase in product of diameters, stable disease (SD); and \>/=25% increase in product of diameters, development of new areas of disease, or disease-attributable clinical deterioration or death, progressive disease (PD). For patients with leukemia PD was defined as \>/=25% or \>/=5,000 cells/mm3 increase in number of circulating cells, development of extramedullary disease, or other clinical evidence of progression.
Outcome measures
| Measure |
5-drug Metronomic Antiangiogenic Regimen
n=97 Participants
Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: \< 20 kg at 100 mg; 20-50 kg at 200 mg; \> 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
|
|---|---|
|
Best Response
Complete Response
|
1 participants
|
|
Best Response
Partial Response
|
12 participants
|
|
Best Response
Stable Disease
|
36 participants
|
|
Best Response
Progressive Disease
|
47 participants
|
|
Best Response
Not Evaluable
|
1 participants
|
Adverse Events
5-drug Metronomic Antiangiogenic Regimen
Serious events: 74 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5-drug Metronomic Antiangiogenic Regimen
n=97 participants at risk
Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: \< 20 kg at 100 mg; 20-50 kg at 200 mg; \> 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
|
|---|---|
|
General disorders
DE140
|
1.0%
1/97 • 27 weeks
|
|
General disorders
Death - disease progression NOS
|
1.0%
1/97 • 27 weeks
|
|
Blood and lymphatic system disorders
Hemoglobin
|
21.6%
21/97 • 27 weeks
|
|
Blood and lymphatic system disorders
Hematologic-other
|
1.0%
1/97 • 27 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.3%
9/97 • 27 weeks
|
|
Ear and labyrinth disorders
Hearing w/w-o audiogr in monitor prg
|
1.0%
1/97 • 27 weeks
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
2.1%
2/97 • 27 weeks
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
2.1%
2/97 • 27 weeks
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
1.0%
1/97 • 27 weeks
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/97 • 27 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/97 • 27 weeks
|
|
Gastrointestinal disorders
Abdomen, pain
|
1.0%
1/97 • 27 weeks
|
|
General disorders
Fatigue
|
11.3%
11/97 • 27 weeks
|
|
General disorders
Fever w/o neutropenia
|
1.0%
1/97 • 27 weeks
|
|
General disorders
Edema limb
|
1.0%
1/97 • 27 weeks
|
|
General disorders
Extremity-lower (gait/walking)
|
1.0%
1/97 • 27 weeks
|
|
Infections and infestations
Infection w/ gr3-4 neut, catheter relate
|
1.0%
1/97 • 27 weeks
|
|
Infections and infestations
Infection w/ gr3-4 neut, lung
|
2.1%
2/97 • 27 weeks
|
|
Infections and infestations
Infection w/ gr3-4 neut, skin
|
1.0%
1/97 • 27 weeks
|
|
Infections and infestations
Infection Gr0-2 neut, mucosa
|
1.0%
1/97 • 27 weeks
|
|
Infections and infestations
Infection w/ unk ANC lung
|
1.0%
1/97 • 27 weeks
|
|
Infections and infestations
Infection w/ unk ANC mucosa
|
1.0%
1/97 • 27 weeks
|
|
Infections and infestations
Infection-other
|
1.0%
1/97 • 27 weeks
|
|
Investigations
Leukocytes
|
58.8%
57/97 • 27 weeks
|
|
Investigations
Lymphopenia
|
38.1%
37/97 • 27 weeks
|
|
Investigations
Neutrophils
|
47.4%
46/97 • 27 weeks
|
|
Investigations
Platelets
|
8.2%
8/97 • 27 weeks
|
|
Investigations
Alkaline phosphatase
|
1.0%
1/97 • 27 weeks
|
|
Investigations
ALT, SGPT
|
5.2%
5/97 • 27 weeks
|
|
Investigations
AST, SGOT
|
3.1%
3/97 • 27 weeks
|
|
Investigations
Metabolic/Laboratory-other
|
2.1%
2/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
2.1%
2/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.0%
1/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.0%
1/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.0%
1/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.0%
1/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.1%
2/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.0%
1/97 • 27 weeks
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
1.0%
1/97 • 27 weeks
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
1.0%
1/97 • 27 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplasia
|
1.0%
1/97 • 27 weeks
|
|
Nervous system disorders
Ataxia
|
1.0%
1/97 • 27 weeks
|
|
Nervous system disorders
Dizziness
|
2.1%
2/97 • 27 weeks
|
|
Nervous system disorders
Neuropathy-motor
|
1.0%
1/97 • 27 weeks
|
|
Nervous system disorders
Depressed level of consciousness
|
2.1%
2/97 • 27 weeks
|
|
Nervous system disorders
Syncope
|
1.0%
1/97 • 27 weeks
|
|
Psychiatric disorders
Agitation
|
1.0%
1/97 • 27 weeks
|
|
Psychiatric disorders
Psychosis
|
1.0%
1/97 • 27 weeks
|
|
Respiratory, thoracic and mediastinal disorders
(ARDS)
|
1.0%
1/97 • 27 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.0%
1/97 • 27 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.1%
2/97 • 27 weeks
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
1.0%
1/97 • 27 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.0%
1/97 • 27 weeks
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.0%
1/97 • 27 weeks
|
Other adverse events
| Measure |
5-drug Metronomic Antiangiogenic Regimen
n=97 participants at risk
Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: \< 20 kg at 100 mg; 20-50 kg at 200 mg; \> 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplasia
|
1.0%
1/97 • 27 weeks
|
|
Blood and lymphatic system disorders
Hemoglobin
|
53.6%
52/97 • 27 weeks
|
|
Cardiac disorders
Palpitations
|
1.0%
1/97 • 27 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
1.0%
1/97 • 27 weeks
|
|
Endocrine disorders
Cushingnoid appearance
|
1.0%
1/97 • 27 weeks
|
|
Eye disorders
Neuropathy CN II vision
|
1.0%
1/97 • 27 weeks
|
|
Eye disorders
Cataract
|
1.0%
1/97 • 27 weeks
|
|
Eye disorders
Keratitis
|
1.0%
1/97 • 27 weeks
|
|
Eye disorders
Ocular-other
|
1.0%
1/97 • 27 weeks
|
|
Gastrointestinal disorders
Constipation
|
16.5%
16/97 • 27 weeks
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
8.2%
8/97 • 27 weeks
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
3.1%
3/97 • 27 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
1.0%
1/97 • 27 weeks
|
|
Gastrointestinal disorders
Enteritis
|
1.0%
1/97 • 27 weeks
|
|
Gastrointestinal disorders
Flatulence
|
2.1%
2/97 • 27 weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.0%
1/97 • 27 weeks
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
3.1%
3/97 • 27 weeks
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
2.1%
2/97 • 27 weeks
|
|
Gastrointestinal disorders
Nausea
|
20.6%
20/97 • 27 weeks
|
|
Gastrointestinal disorders
Vomiting
|
12.4%
12/97 • 27 weeks
|
|
Gastrointestinal disorders
GI-other
|
5.2%
5/97 • 27 weeks
|
|
Gastrointestinal disorders
Anus, hemorrhage
|
1.0%
1/97 • 27 weeks
|
|
Gastrointestinal disorders
Abdomen, pain
|
11.3%
11/97 • 27 weeks
|
|
Gastrointestinal disorders
Anus, pain
|
1.0%
1/97 • 27 weeks
|
|
Gastrointestinal disorders
Oral cavity, pain
|
1.0%
1/97 • 27 weeks
|
|
Gastrointestinal disorders
Stomach, pain
|
1.0%
1/97 • 27 weeks
|
|
General disorders
Fatigue
|
32.0%
31/97 • 27 weeks
|
|
General disorders
Fever w/o neutropenia
|
6.2%
6/97 • 27 weeks
|
|
General disorders
Rigors/chills
|
2.1%
2/97 • 27 weeks
|
|
General disorders
Constitutional, other
|
4.1%
4/97 • 27 weeks
|
|
General disorders
Edema limb
|
1.0%
1/97 • 27 weeks
|
|
General disorders
Extremity-lower (gait/walking)
|
1.0%
1/97 • 27 weeks
|
|
General disorders
Irritability (children <3yrs of age)
|
1.0%
1/97 • 27 weeks
|
|
General disorders
Chest/thoracic pain NOS
|
2.1%
2/97 • 27 weeks
|
|
General disorders
Pain-other
|
3.1%
3/97 • 27 weeks
|
|
Hepatobiliary disorders
Gallbladder, pain
|
1.0%
1/97 • 27 weeks
|
|
Immune system disorders
Allergic reaction
|
1.0%
1/97 • 27 weeks
|
|
Infections and infestations
Infection w/ gr3-4 neut, upper airway
|
3.1%
3/97 • 27 weeks
|
|
Infections and infestations
Infection Gr0-2 neut, lip/perioral
|
1.0%
1/97 • 27 weeks
|
|
Infections and infestations
Infection Gr0-2 neut, mucosa
|
1.0%
1/97 • 27 weeks
|
|
Infections and infestations
Infection Gr0-2 neut, oral cavity
|
1.0%
1/97 • 27 weeks
|
|
Infections and infestations
Infection Gr0-2 neut, upper airway
|
1.0%
1/97 • 27 weeks
|
|
Infections and infestations
Infection w/ unk ANC oral cavity/gums
|
1.0%
1/97 • 27 weeks
|
|
Infections and infestations
Infection Gr 0-2 neut, blood
|
1.0%
1/97 • 27 weeks
|
|
Infections and infestations
Infection-other
|
3.1%
3/97 • 27 weeks
|
|
Injury, poisoning and procedural complications
Bruising
|
1.0%
1/97 • 27 weeks
|
|
Injury, poisoning and procedural complications
Chemoradiation dermatitis
|
1.0%
1/97 • 27 weeks
|
|
Investigations
Leukocytes
|
18.6%
18/97 • 27 weeks
|
|
Investigations
Lymphopenia
|
6.2%
6/97 • 27 weeks
|
|
Investigations
Neutrophils
|
19.6%
19/97 • 27 weeks
|
|
Investigations
Platelets
|
27.8%
27/97 • 27 weeks
|
|
Investigations
Weight gain
|
2.1%
2/97 • 27 weeks
|
|
Investigations
Weight loss
|
3.1%
3/97 • 27 weeks
|
|
Investigations
PTT
|
1.0%
1/97 • 27 weeks
|
|
Investigations
Alkaline phosphatase
|
7.2%
7/97 • 27 weeks
|
|
Investigations
ALT, SGPT
|
33.0%
32/97 • 27 weeks
|
|
Investigations
AST, SGOT
|
25.8%
25/97 • 27 weeks
|
|
Investigations
Bilirubin
|
7.2%
7/97 • 27 weeks
|
|
Investigations
Creatinine
|
5.2%
5/97 • 27 weeks
|
|
Investigations
Metabolic/Laboratory-other
|
2.1%
2/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Obesity
|
1.0%
1/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
7.2%
7/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.3%
9/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Bicarbonate
|
16.5%
16/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.1%
2/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.4%
12/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.6%
18/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.2%
7/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.1%
3/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.2%
6/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.2%
7/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.1%
4/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.2%
5/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.1%
2/97 • 27 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.2%
8/97 • 27 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
1.0%
1/97 • 27 weeks
|
|
Musculoskeletal and connective tissue disorders
Back, pain
|
1.0%
1/97 • 27 weeks
|
|
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
|
4.1%
4/97 • 27 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
1.0%
1/97 • 27 weeks
|
|
Nervous system disorders
Ataxia
|
1.0%
1/97 • 27 weeks
|
|
Nervous system disorders
Dizziness
|
8.2%
8/97 • 27 weeks
|
|
Nervous system disorders
Memory impairment
|
1.0%
1/97 • 27 weeks
|
|
Nervous system disorders
Neuropathy CN V jaw / face-sensory
|
2.1%
2/97 • 27 weeks
|
|
Nervous system disorders
Neuropathy CN XII tongue
|
1.0%
1/97 • 27 weeks
|
|
Nervous system disorders
Neuropathy-motor
|
5.2%
5/97 • 27 weeks
|
|
Nervous system disorders
Neuropathy-sensory
|
10.3%
10/97 • 27 weeks
|
|
Nervous system disorders
Pyramidal tract dysfunction
|
1.0%
1/97 • 27 weeks
|
|
Nervous system disorders
Seizure
|
1.0%
1/97 • 27 weeks
|
|
Nervous system disorders
Depressed level of consciousness
|
3.1%
3/97 • 27 weeks
|
|
Nervous system disorders
Speech impairment
|
1.0%
1/97 • 27 weeks
|
|
Nervous system disorders
Tremor
|
2.1%
2/97 • 27 weeks
|
|
Nervous system disorders
Neurologic-other
|
5.2%
5/97 • 27 weeks
|
|
Nervous system disorders
Head/headache
|
7.2%
7/97 • 27 weeks
|
|
Psychiatric disorders
Insomnia
|
1.0%
1/97 • 27 weeks
|
|
Psychiatric disorders
Confusion
|
4.1%
4/97 • 27 weeks
|
|
Psychiatric disorders
Agitation
|
2.1%
2/97 • 27 weeks
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/97 • 27 weeks
|
|
Psychiatric disorders
Depression
|
3.1%
3/97 • 27 weeks
|
|
Psychiatric disorders
Euphoria
|
1.0%
1/97 • 27 weeks
|
|
Psychiatric disorders
Personality
|
4.1%
4/97 • 27 weeks
|
|
Renal and urinary disorders
Urinary hemorrhage NOS
|
1.0%
1/97 • 27 weeks
|
|
Renal and urinary disorders
Hemoglobinuria
|
1.0%
1/97 • 27 weeks
|
|
Renal and urinary disorders
Proteinuria
|
1.0%
1/97 • 27 weeks
|
|
Renal and urinary disorders
Cystitis
|
1.0%
1/97 • 27 weeks
|
|
Renal and urinary disorders
Incontinence urinary
|
1.0%
1/97 • 27 weeks
|
|
Renal and urinary disorders
Renal/GU-other
|
1.0%
1/97 • 27 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.0%
1/97 • 27 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Muco/stomatitis by exam, pharynx
|
1.0%
1/97 • 27 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Muco/stomatitis (symptom) pharynx
|
1.0%
1/97 • 27 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.1%
2/97 • 27 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.2%
7/97 • 27 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.1%
3/97 • 27 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
3.1%
3/97 • 27 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
1.0%
1/97 • 27 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
5.2%
5/97 • 27 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.1%
2/97 • 27 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.5%
16/97 • 27 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
1.0%
1/97 • 27 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
4.1%
4/97 • 27 weeks
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
9.3%
9/97 • 27 weeks
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
1.0%
1/97 • 27 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.0%
1/97 • 27 weeks
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
2.1%
2/97 • 27 weeks
|
|
Vascular disorders
Hypertension
|
3.1%
3/97 • 27 weeks
|
|
Vascular disorders
Hypotension
|
2.1%
2/97 • 27 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60