Trial Outcomes & Findings for Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer (NCT NCT00075400)
NCT ID: NCT00075400
Last Updated: 2019-07-24
Results Overview
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months.
Results posted on
2019-07-24
Participant Flow
The study was activated on 1/5/2004 and closed to accrual on 8/1/2005.
Participant milestones
| Measure |
Gleevec
Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Gleevec
Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Overall Study
Ineligible: wrong primary
|
1
|
|
Overall Study
Never treated
|
2
|
Baseline Characteristics
Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer
Baseline characteristics by cohort
| Measure |
Gleevec
n=23 Participants
Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 10.2 • n=93 Participants
|
|
Age, Customized
40-49 years
|
3 participants
n=93 Participants
|
|
Age, Customized
50-59 years
|
3 participants
n=93 Participants
|
|
Age, Customized
60-69 years
|
11 participants
n=93 Participants
|
|
Age, Customized
70-79 years
|
4 participants
n=93 Participants
|
|
Age, Customized
80-89 years
|
2 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=93 Participants
|
|
FIGO (International Federation of Gynecology and Obstetrics) Stage Recurrent/Persistent
|
23 participants
n=93 Participants
|
|
Histologic Type
Carcinosarcoma-homologous
|
3 participants
n=93 Participants
|
|
Histologic Type
Carcinosarcoma-heterologous
|
8 participants
n=93 Participants
|
|
Histologic Type
Carcinosarcoma, Malignant Mixed Mullerian Tumor
|
12 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months.Population: Eligible and treated patients.
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Gleevec
n=23 Participants
Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Progression-free Survival (PFS) > 6 Months
|
4.3 percentage of participants
Interval 0.2 to 19.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Each cycle during treatment and 30 days after treatment ends.Population: Eligible and treated patients
The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.
Outcome measures
| Measure |
Gleevec
n=23 Participants
Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
|
Grade 1 (CTCAE v 3.0)
n=23 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
n=23 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
n=23 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
n=23 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Ocular
|
21 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Leukopenia
|
21 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Neutropenia
|
21 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Anemia
|
7 Participants
|
7 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Allergy
|
22 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Hearing
|
22 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Cardiovascular
|
22 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Constitutional
|
7 Participants
|
9 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Dermatologic
|
19 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Endocrine
|
21 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Gastrointestinal
|
5 Participants
|
5 Participants
|
12 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Genitourinary
|
22 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Hemorrhage
|
22 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Lymphatics
|
17 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Metabolic
|
18 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Neuropathy
|
21 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Other neurologic
|
21 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Pain
|
19 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Pulmonary
|
22 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Effects as Assessed by CTCAE v 3.0
Sexual
|
22 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; up to 5 yearsPopulation: Eligible and treated patients
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Outcome measures
| Measure |
Gleevec
n=23 Participants
Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Tumor Response
|
0 percentage of participants
Interval 0.0 to 9.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry to death or last contact, up to 5 years.Population: Eligible and treated patients
The observed length of life from entry into the study to death or the date of last contact
Outcome measures
| Measure |
Gleevec
n=23 Participants
Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Overall Survival
|
4.1 months
Interval 3.3 to 8.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; up to 5 yearsPopulation: Eligible and treated patients.
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Gleevec
n=23 Participants
Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Duration of Progression Free Survival
|
1.6099 months
Interval 0.9199 to 2.1027
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Eligible and treated patients
Performance Status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance Status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work Performance Status 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.
Outcome measures
| Measure |
Gleevec
n=23 Participants
Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Initial Performance Status
Performance status 0
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Initial Performance Status
Performance status 1
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Initial Performance Status
Performance status 2
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Eligible and treated patients
G1 - Highly differentiated adenomatous carcinoma. G2 - Differentiated adenomatous carcinoma with partly solid areas. G3 - Predominantly solid or entirely undifferentiated carcinoma. Not graded - tumor grade not reported.
Outcome measures
| Measure |
Gleevec
n=23 Participants
Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
|
Grade 1 (CTCAE v 3.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|
|
Initial Histologic Grade
Grade 1
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Initial Histologic Grade
Grade 2
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Initial Histologic Grade
Grade 3
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Initial Histologic Grade
Not graded
|
1 Participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePotential associations with clinical or PFS response will be assessed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePotential associations with clinical or PFS response will be assessed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePotential associations with clinical or PFS response will be assessed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePotential associations with clinical or PFS response will be assessed.
Outcome measures
Outcome data not reported
Adverse Events
Gleevec
Serious events: 7 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gleevec
n=23 participants at risk
Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Death No Ctcae Term - Death Nos
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Dehydration
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
Other adverse events
| Measure |
Gleevec
n=23 participants at risk
Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
|
|---|---|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Immune system disorders
Rhinitis
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Neutrophils
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Leukocytes
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Hemoglobin
|
82.6%
19/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Tachycardia
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Weight Gain
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Fever
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Weight Loss
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Fatigue
|
73.9%
17/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.4%
4/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Flushing
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Endocrine disorders
Hot Flashes
|
17.4%
4/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Distention
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Taste Alteration
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Vomiting
|
52.2%
12/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Anorexia
|
34.8%
8/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Constipation
|
13.0%
3/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Nausea
|
73.9%
17/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Diarrhea
|
34.8%
8/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
17.4%
4/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Vascular disorders
Hemorrhage/Pulmonary - Respiratory Tract Nos
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Hepatobiliary disorders
Liver Dysfunction
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Edema: Limb
|
26.1%
6/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Blood and lymphatic system disorders
Edema: Head And Neck
|
21.7%
5/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Ast
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Creatinine
|
17.4%
4/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Alt
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Bilirubin
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Mood Alteration - Depression
|
13.0%
3/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Dizziness
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Neuropathy-Sensory
|
17.4%
4/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Neuropathy-Motor
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Eye disorders
Watery Eye
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Eye disorders
Blurred Vision
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Chest /Thorax Nos
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Head/Headache
|
17.4%
4/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Extremity-Limb
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Back
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Abdominal Pain Nos
|
13.0%
3/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain: Tumor
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.4%
4/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.4%
4/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Urinary Retention
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Incontinence, Urinary
|
8.7%
2/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
4.3%
1/23 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
Additional Information
Angela M. Kuras, Associate Director of Data Management
NRG Oncology Statistics and Data Management Center - Buffalo
Phone: 716-845-7733
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60