Trial Outcomes & Findings for Bevacizumab Study With Carboplatin & Paclitaxel in Ovarian, Fallopian Tube or Primary Peritoneal Cancer (NCT NCT00408070)
NCT ID: NCT00408070
Last Updated: 2018-03-08
Results Overview
This Outcome is measuring the number of particpants who have survived.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
9 months
Results posted on
2018-03-08
Participant Flow
Participant milestones
| Measure |
Bevacizumab Plus Carboplatin and Paclitaxel
This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bevacizumab Study With Carboplatin & Paclitaxel in Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab Plus Carboplatin and Paclitaxel
n=5 Participants
This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsThis Outcome is measuring the number of particpants who have survived.
Outcome measures
| Measure |
Bevacizumab Plus Carboplatin and Paclitaxel
n=5 Participants
This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
|
|---|---|
|
Progression Free Survival Rate at 9 Months
|
4 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: not assessed; study terminated early
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: not assessed; study terminated early
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: weeklyPopulation: not assessed; study terminated early
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: not assessed; study terminated early
Outcome measures
Outcome data not reported
Adverse Events
Bevacizumab Plus Carboplatin and Paclitaxel
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab Plus Carboplatin and Paclitaxel
n=5 participants at risk
This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
|
|---|---|
|
Nervous system disorders
Neuropathy - motor
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Febrile Neutropenia
|
40.0%
2/5 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
20.0%
1/5 • Number of events 1
|
Other adverse events
| Measure |
Bevacizumab Plus Carboplatin and Paclitaxel
n=5 participants at risk
This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
|
|---|---|
|
Blood and lymphatic system disorders
hemoglobin decrease
|
100.0%
5/5
|
|
Skin and subcutaneous tissue disorders
alopecia
|
40.0%
2/5
|
|
Musculoskeletal and connective tissue disorders
pain - musculoskeletal; joint
|
40.0%
2/5
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
20.0%
1/5
|
|
Immune system disorders
allergic reaction / hypersensitivity
|
40.0%
2/5
|
|
Gastrointestinal disorders
bloating /abdominal distention
|
20.0%
1/5
|
|
Blood and lymphatic system disorders
metabolic laboratory - other
|
20.0%
1/5
|
|
Skin and subcutaneous tissue disorders
bruising
|
20.0%
1/5
|
|
Nervous system disorders
confusion
|
20.0%
1/5
|
|
Gastrointestinal disorders
constipation
|
40.0%
2/5
|
|
Gastrointestinal disorders
dehydration
|
40.0%
2/5
|
|
Gastrointestinal disorders
diarrhea
|
60.0%
3/5
|
|
Gastrointestinal disorders
dysgeusia
|
60.0%
3/5
|
|
Nervous system disorders
dizziness
|
20.0%
1/5
|
|
Blood and lymphatic system disorders
edema - limb
|
20.0%
1/5
|
|
Blood and lymphatic system disorders
alkaline phosphatase - elevated
|
20.0%
1/5
|
|
Blood and lymphatic system disorders
creatinine - elevated
|
40.0%
2/5
|
|
Blood and lymphatic system disorders
ALT (SGPT) - evelated
|
20.0%
1/5
|
|
Blood and lymphatic system disorders
AST (SGOT) - elevated
|
20.0%
1/5
|
|
Blood and lymphatic system disorders
lactose dehydrogenase (LDH) - elevated
|
20.0%
1/5
|
|
General disorders
fatigue
|
100.0%
5/5
|
|
Infections and infestations
febrile neutorpenia
|
20.0%
1/5
|
|
Gastrointestinal disorders
flatulence
|
20.0%
1/5
|
|
Gastrointestinal disorders
gastritis
|
20.0%
1/5
|
|
Gastrointestinal disorders
dyspepsia
|
60.0%
3/5
|
|
General disorders
headache
|
20.0%
1/5
|
|
Ear and labyrinth disorders
hearing alteration
|
20.0%
1/5
|
|
Blood and lymphatic system disorders
hemoglobin - elevated
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
hyperglycemia
|
80.0%
4/5
|
|
Blood and lymphatic system disorders
hypoalbuminemia
|
80.0%
4/5
|
|
Blood and lymphatic system disorders
hyponatremia
|
100.0%
5/5
|
|
Blood and lymphatic system disorders
hypocalcemia
|
40.0%
2/5
|
|
Blood and lymphatic system disorders
hypokalemia
|
20.0%
1/5
|
|
Blood and lymphatic system disorders
hypomagnesemia
|
80.0%
4/5
|
|
Cardiac disorders
hypertension
|
40.0%
2/5
|
|
Infections and infestations
Infection - skin
|
20.0%
1/5
|
|
Infections and infestations
infection - urinary tract
|
40.0%
2/5
|
|
Infections and infestations
infection - upper respiratory
|
40.0%
2/5
|
|
Infections and infestations
infection - NOS
|
20.0%
1/5
|
|
Skin and subcutaneous tissue disorders
injection site reaction
|
20.0%
1/5
|
|
Blood and lymphatic system disorders
leukocytes - decreased
|
100.0%
5/5
|
|
Blood and lymphatic system disorders
bicarbonate - decreased
|
40.0%
2/5
|
|
Musculoskeletal and connective tissue disorders
pain, bone
|
20.0%
1/5
|
|
Blood and lymphatic system disorders
lymphopenia
|
60.0%
3/5
|
|
Gastrointestinal disorders
mucositis/stomatitis
|
20.0%
1/5
|
|
Nervous system disorders
memory impairment
|
20.0%
1/5
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
20.0%
1/5
|
|
Respiratory, thoracic and mediastinal disorders
nasal/sinus reactions
|
60.0%
3/5
|
|
Skin and subcutaneous tissue disorders
nail changes
|
20.0%
1/5
|
|
Gastrointestinal disorders
nausea
|
80.0%
4/5
|
|
Nervous system disorders
neuropathy - sensory
|
100.0%
5/5
|
|
Nervous system disorders
neuropathy - cranial
|
20.0%
1/5
|
|
Blood and lymphatic system disorders
neutrophils/granulocytes - decreased
|
100.0%
5/5
|
|
Musculoskeletal and connective tissue disorders
pain - extremity
|
40.0%
2/5
|
|
Musculoskeletal and connective tissue disorders
pain - muscle
|
20.0%
1/5
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
20.0%
1/5
|
|
Renal and urinary disorders
proteinuria
|
40.0%
2/5
|
|
Skin and subcutaneous tissue disorders
pruritus
|
20.0%
1/5
|
|
General disorders
rigors / chills
|
20.0%
1/5
|
|
Skin and subcutaneous tissue disorders
rash
|
20.0%
1/5
|
|
Skin and subcutaneous tissue disorders
eczema
|
20.0%
1/5
|
|
Immune system disorders
allergic rhinitis
|
20.0%
1/5
|
|
Blood and lymphatic system disorders
platelets - decreased
|
100.0%
5/5
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
20.0%
1/5
|
|
Gastrointestinal disorders
vomiting
|
60.0%
3/5
|
|
Respiratory, thoracic and mediastinal disorders
dysarthria
|
20.0%
1/5
|
|
Metabolism and nutrition disorders
weight loss
|
20.0%
1/5
|
|
Nervous system disorders
neuropathy - cranial -CN V
|
20.0%
1/5
|
|
Respiratory, thoracic and mediastinal disorders
respiratory - other (cold symptoms)
|
20.0%
1/5
|
|
Musculoskeletal and connective tissue disorders
seroma
|
20.0%
1/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60