Trial Outcomes & Findings for VEGF Trap in Treating Patients With Recurrent or Persistent Endometrial Cancer (NCT NCT00462826)
NCT ID: NCT00462826
Last Updated: 2019-07-23
Results Overview
Number of participants who survived progression-free for more than 6 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
At 6 monthsEvery other cycle during treatment for the first 6 months.
Results posted on
2019-07-23
Participant Flow
Patients were accrued to the first stage of accrual from 11/5/2007 to 6/2/2008. Patients were accrued to the second stage between 4/6/2009 and 7/13/2009. They received 4 mg/kg IV of VEGF-Trap every two weeks. One cycle was 28 days.
Patients were required to have had one prior chemotherapeutic regimen for the treatment of endometrial carcinoma. Patients entering the study therefore were required to have either persistent or recurrent cancer that was measurable by RECIST.
Participant milestones
| Measure |
Treatment (Aflibercept)
Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment (Aflibercept)
Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Ineligible - second primary
|
1
|
|
Overall Study
Ineligible - wrong cell type
|
1
|
|
Overall Study
Ineligible - wrong primary
|
2
|
|
Overall Study
Never treated
|
1
|
Baseline Characteristics
VEGF Trap in Treating Patients With Recurrent or Persistent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Aflibercept)
n=44 Participants
Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
|
Age, Customized
40-49 years
|
3 participants
n=99 Participants
|
|
Age, Customized
50-59 years
|
13 participants
n=99 Participants
|
|
Age, Customized
60-69 years
|
15 participants
n=99 Participants
|
|
Age, Customized
70-79 years
|
12 participants
n=99 Participants
|
|
Age, Customized
80-89 years
|
1 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=99 Participants
|
|
International Federation of Gynecology and Obstetrics (FIGO) Recurrent/Persistent Disease
|
44 participants
n=99 Participants
|
|
Cell Type
Adenocarcinoma, Unspecified
|
1 participants
n=99 Participants
|
|
Cell Type
Clear Cell Carcinoma
|
1 participants
n=99 Participants
|
|
Cell Type
Endometrioid Adenocarcinoma
|
23 participants
n=99 Participants
|
|
Cell Type
Mucinous Adenocarcinoma
|
1 participants
n=99 Participants
|
|
Cell Type
Mixed Epithelial Carcinoma
|
6 participants
n=99 Participants
|
|
Cell Type
Carcinsarcoma, MMT
|
1 participants
n=99 Participants
|
|
Cell Type
Serous Adenocarcinoma
|
11 participants
n=99 Participants
|
|
Reason Off Study Therapy
Disease Progression
|
25 participants
n=99 Participants
|
|
Reason Off Study Therapy
Refused Further Treatment
|
1 participants
n=99 Participants
|
|
Reason Off Study Therapy
Toxicity as permitted
|
14 participants
n=99 Participants
|
|
Reason Off Study Therapy
Death
|
3 participants
n=99 Participants
|
|
Reason Off Study Therapy
Other
|
1 participants
n=99 Participants
|
|
Tumor Response
Partial Response
|
3 participants
n=99 Participants
|
|
Tumor Response
Stable Disease
|
14 participants
n=99 Participants
|
|
Tumor Response
Increase Disease
|
16 participants
n=99 Participants
|
|
Tumor Response
Indeterminate
|
11 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsEvery other cycle during treatment for the first 6 months.Number of participants who survived progression-free for more than 6 months.
Outcome measures
| Measure |
Treatment (Aflibercept)
n=44 Participants
Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
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
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
6 Month Progression-free Survival
|
18 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Every other cycle during treatment for the first 6 months, then every 3 months thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease; up to 5 years.Population: Eligible and evaluable 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 |
Treatment (Aflibercept)
n=44 Participants
Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
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
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Objective Tumor Response (RECIST 1.0)
Complete Response
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Objective Tumor Response (RECIST 1.0)
Partial Response
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed every cycle while on treatment, 30 days after the last cycle of treatmentPopulation: Eligible and evaluable patients.
Adverse events at least possibly related to the study agent.
Outcome measures
| Measure |
Treatment (Aflibercept)
n=44 Participants
Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Grade 1 (CTCAE v 3.0)
n=44 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0
|
Grade 2 (CTCAE v 3.0)
n=44 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0
|
Grade 3 (CTCAE v 3.0)
n=44 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0
|
Grade 4 (CTCAE v 3.0)
n=44 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0
|
Grade 5 (CTCAE v 3.0)
n=44 Participants
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Leukopenia
|
37 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Thrombocytopenia
|
36 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Allergy/Immunology
|
40 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Constitutional
|
16 Participants
|
13 Participants
|
12 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Pulmonary
|
23 Participants
|
13 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Gastrointestinal
|
14 Participants
|
15 Participants
|
10 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Genitourinary/renal
|
41 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Hemorrhage
|
36 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Infection
|
39 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Lymphatics
|
40 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Metabolic
|
27 Participants
|
10 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Musculoskeletal
|
41 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Neurosensory
|
38 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Other neurological
|
31 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Ocular/visual
|
42 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Pain
|
13 Participants
|
15 Participants
|
8 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Neutropenia
|
41 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Anemia
|
25 Participants
|
9 Participants
|
9 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Other hematologic
|
40 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Cardiac
|
23 Participants
|
1 Participants
|
8 Participants
|
10 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Coagulation
|
39 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Dermatologic
|
36 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Endocrine
|
42 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Nausea
|
25 Participants
|
12 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Vomiting
|
32 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Adverse Events at Least Possibly Related to Study Agent as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Vascular
|
43 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Every other cycle during treatment for the first 6 months, then every 3 months thereafter; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease; up to 5 years.Population: Eligible and evaluable 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 |
Treatment (Aflibercept)
n=44 Participants
Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
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
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Duration of Progression-free Survival
|
2.9 months
Interval 2.1 to 6.21
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.Population: Eligible and evaluable patients
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Outcome measures
| Measure |
Treatment (Aflibercept)
n=44 Participants
Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
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
|
Grade 5 (CTCAE v 3.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
|
|---|---|---|---|---|---|---|
|
Duration of Overall Survival
|
14.5 months
Interval 9.86 to 20.44
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Treatment (Aflibercept)
Serious events: 24 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Aflibercept)
n=44 participants at risk
Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophils
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Cardiac disorders
Hypertension
|
4.5%
2/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Cardiac disorders
Lt Ventricular Systolic Dysfunction
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
General disorders
Fever
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
6.8%
3/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Gastrointestinal disorders
Perforation, Gi - Colon
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Gastrointestinal disorders
Ileus
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Vascular disorders
Hemorrhage, Cns
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Proteinuria
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Creatinine
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Nervous system disorders
Neurology - Other
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Nervous system disorders
Encephalopathy
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Nervous system disorders
Seizure
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Nervous system disorders
Cns Ischemia
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Nervous system disorders
Confusion
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
General disorders
Pain: Pelvis
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
General disorders
Pain: Chest Wall
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Vascular disorders
Vascular - Other
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
2.3%
1/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
Other adverse events
| Measure |
Treatment (Aflibercept)
n=44 participants at risk
Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Immune system disorders
Rhinitis
|
11.4%
5/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Ear and labyrinth disorders
Tinnitus
|
11.4%
5/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Blood and lymphatic system disorders
Platelets
|
20.5%
9/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Blood and lymphatic system disorders
Leukocytes
|
15.9%
7/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.1%
4/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
50.0%
22/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Cardiac disorders
Hypertension
|
43.2%
19/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Vascular disorders
Inr
|
6.8%
3/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Vascular disorders
Ptt
|
6.8%
3/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
General disorders
Weight Loss
|
6.8%
3/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
General disorders
Fatigue
|
63.6%
28/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
13.6%
6/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
15.9%
7/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.6%
6/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Endocrine disorders
Hot Flashes
|
6.8%
3/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Gastrointestinal disorders
Dysphagia
|
11.4%
5/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Gastrointestinal disorders
Taste Alteration
|
6.8%
3/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
6.8%
3/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
25.0%
11/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
12/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Gastrointestinal disorders
Anorexia
|
34.1%
15/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Gastrointestinal disorders
Constipation
|
36.4%
16/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Gastrointestinal disorders
Nausea
|
43.2%
19/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Gastrointestinal disorders
Diarrhea
|
22.7%
10/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
6.8%
3/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
11.4%
5/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
11.4%
5/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
11.4%
5/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Ast
|
20.5%
9/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
6.8%
3/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Proteinuria
|
9.1%
4/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Creatinine
|
22.7%
10/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
27.3%
12/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Alt
|
9.1%
4/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
20.5%
9/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
29.5%
13/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
22.7%
10/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
15.9%
7/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
36.4%
16/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.4%
5/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
13.6%
6/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
6.8%
3/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Nervous system disorders
Mood Alteration - Depression
|
20.5%
9/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Nervous system disorders
Neuropathy-Sensory
|
40.9%
18/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Eye disorders
Blurred Vision
|
6.8%
3/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
General disorders
Pain: Head/Headache
|
38.6%
17/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
General disorders
Pain: Extremity-Limb
|
11.4%
5/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
General disorders
Pain: Joint
|
22.7%
10/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
General disorders
Pain: Abdominal Pain Nos
|
20.5%
9/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
27.3%
12/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
11/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
31.8%
14/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
|
Renal and urinary disorders
Urinary Frequency
|
11.4%
5/44 • From the time of study activation until 7-8-2011 when the last form was submitted.
|
Additional Information
Melissa Leventhal
Gynecologic Oncology Group Statistical and Data Center
Phone: 716-845-4030
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60