Trial Outcomes & Findings for Open Trial of Bendamustine Hydrochloride in Women With Advanced Ovarian Cancer (NCT NCT00867503)
NCT ID: NCT00867503
Last Updated: 2018-07-24
Results Overview
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria or Cancer Antigen (CA)125 response using the modified Gynecologic Cancer Intergroup(GCIG) criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
life of the study
Results posted on
2018-07-24
Participant Flow
Participant milestones
| Measure |
Bendamustine
Bendamustine Hydrochloride (HCL) 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Bendamustine
Bendamustine Hydrochloride (HCL) 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Open Trial of Bendamustine Hydrochloride in Women With Advanced Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Bendamustine
n=10 Participants
bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
|
Primary Site
Ovarian
|
9 participants
n=5 Participants
|
|
Primary Site
Peritoneal
|
1 participants
n=5 Participants
|
|
Median number of prior regimens
|
5 Regimens
n=5 Participants
|
|
Eastern Cooperative Oncology Group performance status
0
|
9 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group performance status
1
|
1 Participants
n=5 Participants
|
|
Tumor Grade
2
|
2 Participants
n=5 Participants
|
|
Tumor Grade
3
|
8 Participants
n=5 Participants
|
|
Cell Type
Serous
|
6 Participants
n=5 Participants
|
|
Cell Type
Endometrioid
|
3 Participants
n=5 Participants
|
|
Cell Type
Clear Cell
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: life of the studyProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria or Cancer Antigen (CA)125 response using the modified Gynecologic Cancer Intergroup(GCIG) criteria
Outcome measures
| Measure |
Bendamustine Median Progression Free Surivial in Months
n=10 Participants
bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
|
|---|---|
|
Progression Free Survival in Patients With Platinum and Taxane Refractory Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer With Bendamustine Treatment.
|
140 Days
Interval 23.0 to 316.0
|
PRIMARY outcome
Timeframe: Life of studyOutcome measures
| Measure |
Bendamustine Median Progression Free Surivial in Months
n=10 Participants
bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
|
|---|---|
|
Overall Survival in Patients With Platinum and Taxane Refractory Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer With Bendamustine Treatment.
|
393 Days
Interval 234.0 to 925.0
|
SECONDARY outcome
Timeframe: Life of the studyGrade 4 Toxicity
Outcome measures
| Measure |
Bendamustine Median Progression Free Surivial in Months
n=10 Participants
bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
|
|---|---|
|
Toxicities of Patients Treated With Bendamustine.
|
0 Partcipants
|
Adverse Events
Bendamustine
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bendamustine
n=10 participants at risk
bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
|
|---|---|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
20.0%
2/10 • Number of events 4 • Life of study
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
1/10 • Number of events 1 • Life of study
|
Other adverse events
| Measure |
Bendamustine
n=10 participants at risk
bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
|
|---|---|
|
General disorders
Fatigue
|
40.0%
4/10 • Life of study
|
|
General disorders
Fever
|
30.0%
3/10 • Life of study
|
|
General disorders
Rigors
|
20.0%
2/10 • Life of study
|
|
General disorders
Weight Loss
|
10.0%
1/10 • Life of study
|
|
Cardiac disorders
Hypotension
|
10.0%
1/10 • Life of study
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Life of study
|
|
Skin and subcutaneous tissue disorders
Other
|
10.0%
1/10 • Life of study
|
|
Psychiatric disorders
Anoxeria
|
20.0%
2/10 • Life of study
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Life of study
|
|
General disorders
Dehydration
|
10.0%
1/10 • Life of study
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Life of study
|
|
General disorders
Distention
|
10.0%
1/10 • Life of study
|
|
General disorders
Dysgeusia
|
30.0%
3/10 • Life of study
|
|
General disorders
Nausea
|
60.0%
6/10 • Life of study
|
|
General disorders
Oral Mucositis
|
20.0%
2/10 • Life of study
|
|
General disorders
Vomiting
|
50.0%
5/10 • Life of study
|
|
Gastrointestinal disorders
Other GI
|
20.0%
2/10 • Life of study
|
|
Blood and lymphatic system disorders
Leukocytes
|
60.0%
6/10 • Life of study
|
|
Blood and lymphatic system disorders
Neutrophils
|
50.0%
5/10 • Life of study
|
|
Blood and lymphatic system disorders
Hemoglobin
|
50.0%
5/10 • Life of study
|
|
Blood and lymphatic system disorders
Platlets
|
50.0%
5/10 • Life of study
|
|
Infections and infestations
Cellulitis
|
10.0%
1/10 • Life of study
|
|
Metabolism and nutrition disorders
Creatinine
|
10.0%
1/10 • Life of study
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
10.0%
1/10 • Life of study
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
1/10 • Life of study
|
|
Metabolism and nutrition disorders
Hypoantremia
|
10.0%
1/10 • Life of study
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness/ Cramping
|
20.0%
2/10 • Life of study
|
|
General disorders
Dizziness
|
20.0%
2/10 • Life of study
|
|
General disorders
Sensory Neuropathy
|
20.0%
2/10 • Life of study
|
|
General disorders
Pain Abdominal, chest, back
|
30.0%
3/10 • Life of study
|
|
General disorders
Headache
|
10.0%
1/10 • Life of study
|
|
General disorders
COugh/Dyspnea
|
20.0%
2/10 • Life of study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place