Trial Outcomes & Findings for Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer (NCT NCT00023712)
NCT ID: NCT00023712
Last Updated: 2019-07-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
From study entry, up to 5 years
Results posted on
2019-07-30
Participant Flow
Accrual was broken down into two cohorts. Cohort 1 enrolled 28 participants from 11/5/2001 through 1/6/2003. Cohort 2 enrolled 30 participants from 4/5/2004 through 9/6/2005.
Participant milestones
| Measure |
Cohort 1 - Bortezomib (1.5 mg/m2)
Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Cohort 2 - Bortezomib (1.3 mg/m2)
Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
|
Overall Study
COMPLETED
|
26
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1 - Bortezomib (1.5 mg/m2)
Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Cohort 2 - Bortezomib (1.3 mg/m2)
Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
|---|---|---|
|
Overall Study
Not platinum sensitive
|
1
|
0
|
|
Overall Study
Never treated
|
1
|
1
|
Baseline Characteristics
Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1
n=26 Participants
Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Cohort 2
n=29 Participants
Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Age, Customized
20-29 years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
6 participants
n=5 Participants
|
11 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
29 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Cell Type
Adenocarcinoma, Unspecified
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Cell Type
Endometrioid Adenocarcinoma
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Cell Type
Mixed Epithelial Carcinoma
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Cell Type
Serous Adenocarcinoma
|
21 participants
n=5 Participants
|
25 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Cell Type
Transitional Cell Carcinoma
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Cell Type
Undifferentiated Carcinoma
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From study entry, up to 5 yearsRECIST 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 |
Cohort 1 - Bortezomib 1.5 (mg/m2)
n=26 Participants
Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Cohort 2 - Bortezomib (1.3 mg/m2)
n=29 Participants
Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Grade 2 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 2.0 in Cohort 1.
|
Grade 3 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 2.0 in cohort 1
|
Grade 4 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 2.0 in cohort 1.
|
Grade 0 AEs Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who did not experience the specified AE in cohort 2
|
Grade 1 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 2.0 in cohort 2.
|
Grade 2 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 2.0 in cohort 2
|
Grade 3 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 2.0 in cohort 2.
|
Grade 4 AEs (CTCAE v 2.0) Cohort 2- Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 2.0 in cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Tumor Response Duration
|
3.9 months
Interval 3.9 to 3.9
|
24.1 months
Interval 2.4 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible and evaluable patients
Outcome measures
| Measure |
Cohort 1 - Bortezomib 1.5 (mg/m2)
n=26 Participants
Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Cohort 2 - Bortezomib (1.3 mg/m2)
n=26 Participants
Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Grade 2 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)
n=26 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 2.0 in Cohort 1.
|
Grade 3 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)
n=26 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 2.0 in cohort 1
|
Grade 4 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)
n=26 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 2.0 in cohort 1.
|
Grade 0 AEs Cohort 2 - Bortezomib (1.3 mg/m2)
n=29 Participants
Number of patients who did not experience the specified AE in cohort 2
|
Grade 1 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)
n=29 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 2.0 in cohort 2.
|
Grade 2 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)
n=29 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 2.0 in cohort 2
|
Grade 3 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)
n=29 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 2.0 in cohort 2.
|
Grade 4 AEs (CTCAE v 2.0) Cohort 2- Bortezomib (1.3 mg/m2)
n=29 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 2.0 in cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency and Severity of Observed Adverse Events
Pulmonary
|
21 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
26 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Events
Platelets
|
14 Participants
|
9 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
16 Participants
|
10 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Events
Absolute neutrophil count (ANC)
|
18 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
21 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Events
Fatigue
|
4 Participants
|
10 Participants
|
10 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
11 Participants
|
6 Participants
|
5 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Events
Rash
|
14 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
17 Participants
|
9 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Events
Diarrhea
|
13 Participants
|
7 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
21 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Events
Constipation
|
17 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
11 Participants
|
7 Participants
|
9 Participants
|
0 Participants
|
2 Participants
|
|
Frequency and Severity of Observed Adverse Events
Genitourinary/renal
|
24 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
25 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Events
Hepatic
|
21 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
22 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Events
Infection
|
23 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
25 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Events
Metabolic
|
21 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
24 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Events
Neuropathy (sensory)
|
14 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
15 Participants
|
8 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Frequency and Severity of Observed Adverse Events
Pain
|
12 Participants
|
8 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
15 Participants
|
5 Participants
|
7 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From study entry until disease progression/intolerable toxicity/study withdrawalNumber of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or \>= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is 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.
Outcome measures
| Measure |
Cohort 1 - Bortezomib 1.5 (mg/m2)
n=26 Participants
Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Cohort 2 - Bortezomib (1.3 mg/m2)
n=29 Participants
Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Grade 2 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 2.0 in Cohort 1.
|
Grade 3 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 2.0 in cohort 1
|
Grade 4 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 2.0 in cohort 1.
|
Grade 0 AEs Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who did not experience the specified AE in cohort 2
|
Grade 1 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 2.0 in cohort 2.
|
Grade 2 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 2.0 in cohort 2
|
Grade 3 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 2.0 in cohort 2.
|
Grade 4 AEs (CTCAE v 2.0) Cohort 2- Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 2.0 in cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Partial/Complete Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
|
1 participants
|
2 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry, up to 5 years following disease progressionOutcome measures
| Measure |
Cohort 1 - Bortezomib 1.5 (mg/m2)
n=26 Participants
Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Cohort 2 - Bortezomib (1.3 mg/m2)
n=29 Participants
Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Grade 2 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 2.0 in Cohort 1.
|
Grade 3 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 2.0 in cohort 1
|
Grade 4 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 2.0 in cohort 1.
|
Grade 0 AEs Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who did not experience the specified AE in cohort 2
|
Grade 1 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 2.0 in cohort 2.
|
Grade 2 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 2.0 in cohort 2
|
Grade 3 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 2.0 in cohort 2.
|
Grade 4 AEs (CTCAE v 2.0) Cohort 2- Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 2.0 in cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival
|
18.2 months
Interval 13.0 to 29.0
|
27.2 months
Interval 12.7 to 37.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From study entry up to 5 yearsProgression 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 |
Cohort 1 - Bortezomib 1.5 (mg/m2)
n=26 Participants
Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Cohort 2 - Bortezomib (1.3 mg/m2)
n=29 Participants
Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Grade 2 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 2.0 in Cohort 1.
|
Grade 3 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 2.0 in cohort 1
|
Grade 4 AEs (CTCAE v 2.0) Cohort 1 - Bortezomib 1.5 (mg/m2)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 2.0 in cohort 1.
|
Grade 0 AEs Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who did not experience the specified AE in cohort 2
|
Grade 1 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 2.0 in cohort 2.
|
Grade 2 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 2.0 in cohort 2
|
Grade 3 AEs (CTCAE v 2.0) Cohort 2 - Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 2.0 in cohort 2.
|
Grade 4 AEs (CTCAE v 2.0) Cohort 2- Bortezomib (1.3 mg/m2)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 2.0 in cohort 2.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival
|
1.5 months
Interval 1.3 to 4.8
|
1.4 months
Interval 1.4 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1
Serious events: 5 serious events
Other events: 26 other events
Deaths: 0 deaths
Cohort 2
Serious events: 6 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=26 participants at risk
Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Cohort 2
n=29 participants at risk
Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/26 • 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.
|
3.4%
1/29 • 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
Caridic Left Ventricular Function
|
0.00%
0/26 • 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.
|
3.4%
1/29 • 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
Ileus
|
0.00%
0/26 • 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.
|
3.4%
1/29 • 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 Without Colostomy
|
3.8%
1/26 • 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.
|
0.00%
0/29 • 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
|
0.00%
0/26 • 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.
|
6.9%
2/29 • 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
Gi Other
|
0.00%
0/26 • 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.
|
3.4%
1/29 • 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
Sgot(Ast)
|
3.8%
1/26 • 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.
|
0.00%
0/29 • 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
Cns Cerebrovascular Ischemia
|
0.00%
0/26 • 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.
|
3.4%
1/29 • 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
Neuropathic Pain
|
3.8%
1/26 • 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.
|
0.00%
0/29 • 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
Headache
|
0.00%
0/26 • 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.
|
3.4%
1/29 • 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
Myalgia
|
3.8%
1/26 • 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.
|
0.00%
0/29 • 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
|
7.7%
2/26 • 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.
|
0.00%
0/29 • 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 |
Cohort 1
n=26 participants at risk
Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
Cohort 2
n=29 participants at risk
Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.5%
3/26 • 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.
|
6.9%
2/29 • 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
Confusion
|
7.7%
2/26 • 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.
|
3.4%
1/29 • 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
Alkaline Phosphatase
|
7.7%
2/26 • 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.
|
10.3%
3/29 • 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
Infection Without Neutropenia
|
11.5%
3/26 • 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.
|
24.1%
7/29 • 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
Metabolic Other
|
3.8%
1/26 • 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.
|
13.8%
4/29 • 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
Hyponatremia
|
11.5%
3/26 • 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.
|
0.00%
0/29 • 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
|
7.7%
2/26 • 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.
|
3.4%
1/29 • 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
|
0.00%
0/26 • 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.
|
20.7%
6/29 • 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 Anxiety/Agitation
|
3.8%
1/26 • 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.
|
17.2%
5/29 • 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
Insomnia
|
11.5%
3/26 • 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.
|
10.3%
3/29 • 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
|
3.8%
1/26 • 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.
|
10.3%
3/29 • 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
|
11.5%
3/26 • 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.
|
24.1%
7/29 • 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 Sensor
|
42.3%
11/26 • 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.
|
48.3%
14/29 • 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
Ocular Other
|
0.00%
0/26 • 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.
|
10.3%
3/29 • 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
Vision Flashing Lights/Floaters
|
7.7%
2/26 • 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.
|
0.00%
0/29 • 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
Vision Blurres
|
3.8%
1/26 • 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.
|
10.3%
3/29 • 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
Abdominal Pain
|
42.3%
11/26 • 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.
|
44.8%
13/29 • 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 Other
|
23.1%
6/26 • 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.
|
24.1%
7/29 • 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
Neuropathic Pain
|
0.00%
0/26 • 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.
|
13.8%
4/29 • 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
Headache
|
19.2%
5/26 • 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.
|
31.0%
9/29 • 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
Chest Pain
|
11.5%
3/26 • 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.
|
3.4%
1/29 • 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
Bone Pain
|
3.8%
1/26 • 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.
|
13.8%
4/29 • 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
Arthralgia
|
19.2%
5/26 • 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.
|
20.7%
6/29 • 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
Myalgia
|
23.1%
6/26 • 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.
|
20.7%
6/29 • 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
|
11.5%
3/26 • 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.
|
3.4%
1/29 • 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
Pneumonitis/Pulmonary Infiltrates
|
0.00%
0/26 • 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.
|
6.9%
2/29 • 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
|
23.1%
6/26 • 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.
|
24.1%
7/29 • 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
Creatinine
|
7.7%
2/26 • 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.
|
6.9%
2/29 • 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
|
0.00%
0/26 • 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.
|
6.9%
2/29 • 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
Inner Ear/Hearing
|
3.8%
1/26 • 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.
|
6.9%
2/29 • 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
Neutropenia
|
30.8%
8/26 • 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.
|
27.6%
8/29 • 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
Thrombocytopenia
|
46.2%
12/26 • 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.
|
48.3%
14/29 • 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
Leukopenia
|
23.1%
6/26 • 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.
|
31.0%
9/29 • 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
Transfusion Prbc's
|
3.8%
1/26 • 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.
|
6.9%
2/29 • 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
Anemia
|
69.2%
18/26 • 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.
|
58.6%
17/29 • 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
Edema
|
11.5%
3/26 • 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.
|
3.4%
1/29 • 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(No Neutropenia)
|
11.5%
3/26 • 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.
|
17.2%
5/29 • 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(No Vod)
|
7.7%
2/26 • 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.
|
3.4%
1/29 • 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
|
80.8%
21/26 • 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.
|
75.9%
22/29 • 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
Alopecia
|
3.8%
1/26 • 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.
|
10.3%
3/29 • 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 Desquamation
|
38.5%
10/26 • 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.
|
20.7%
6/29 • 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
Urticaria
|
7.7%
2/26 • 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.
|
3.4%
1/29 • 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
|
19.2%
5/26 • 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.
|
27.6%
8/29 • 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 Without Colostomy
|
42.3%
11/26 • 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.
|
27.6%
8/29 • 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
|
38.5%
10/26 • 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.
|
62.1%
18/29 • 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
Stomatitis/Pharyngitis
|
15.4%
4/26 • 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.
|
10.3%
3/29 • 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
Vomitting
|
30.8%
8/26 • 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.
|
34.5%
10/29 • 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
|
57.7%
15/26 • 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.
|
44.8%
13/29 • 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
Gi Other
|
7.7%
2/26 • 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.
|
0.00%
0/29 • 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
Hypoalbuminemia
|
3.8%
1/26 • 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.
|
10.3%
3/29 • 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
Sgot(Alt)
|
15.4%
4/26 • 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.
|
24.1%
7/29 • 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
Sgot(Ast)
|
3.8%
1/26 • 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.
|
13.8%
4/29 • 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
Melissa Leventhal
Gynecologic Oncology Group(GOG) 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