Trial Outcomes & Findings for A Study of Carboplatin and DOXIL Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers (NCT NCT00698451)
NCT ID: NCT00698451
Last Updated: 2013-09-06
Results Overview
Objective Response Rate to Treatment is defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR). A Complete Response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days)
Results posted on
2013-09-06
Participant Flow
Participant milestones
| Measure |
DOXIL/CARBOPLATIN/BEVACIZUMAB
Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
39
|
Reasons for withdrawal
| Measure |
DOXIL/CARBOPLATIN/BEVACIZUMAB
Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
|
|---|---|
|
Overall Study
Adverse Event
|
22
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Disease progression
|
3
|
Baseline Characteristics
A Study of Carboplatin and DOXIL Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
Baseline characteristics by cohort
| Measure |
DOXIL/CARBOPLATIN/BEVACIZUMAB
n=54 Participants
Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=93 Participants
|
|
Age Continuous
|
62.1 years
STANDARD_DEVIATION 9.00 • n=93 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days)Population: ITT
Objective Response Rate to Treatment is defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR). A Complete Response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
Outcome measures
| Measure |
DOXIL/CARBOPLATIN/BEVACIZUMAB
n=54 Participants
doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle
|
|---|---|
|
The Primary Efficacy End Point is the Number of Patients With an Objective Response.
|
39 Participants
|
SECONDARY outcome
Timeframe: Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.Population: ITT
Objective Response Rate to Treatment Defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR) Where a Complete response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Duration of response: Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.
Outcome measures
| Measure |
DOXIL/CARBOPLATIN/BEVACIZUMAB
n=54 Participants
doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle
|
|---|---|
|
The Secondary Efficacy Endpoints is Duration of Objective Response.
|
362 Days
Interval 282.0 to
Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.
|
Adverse Events
DOXIL/CARBOPLATIN/BEVACIZUMAB
Serious events: 15 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DOXIL/CARBOPLATIN/BEVACIZUMAB
n=54 participants at risk
Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Small Intestinal Perforation
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Abdominal Abscess
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Bacteraemia
|
1.9%
1/54 • Number of events 1
|
|
Infections and infestations
Staphylococcal Infection
|
1.9%
1/54 • Number of events 1
|
|
Injury, poisoning and procedural complications
Corneal Abrasion
|
1.9%
1/54 • Number of events 1
|
|
Injury, poisoning and procedural complications
Device Malfunction
|
1.9%
1/54 • Number of events 1
|
|
Injury, poisoning and procedural complications
Device Occlusion
|
1.9%
1/54 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
3.7%
2/54 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.9%
1/54 • Number of events 1
|
|
Vascular disorders
Deep Vein Thrombosis
|
3.7%
2/54 • Number of events 2
|
|
Vascular disorders
Hypertension
|
1.9%
1/54 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/54 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.9%
1/54 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.9%
1/54 • Number of events 1
|
|
Renal and urinary disorders
Ureteric Obstruction
|
1.9%
1/54 • Number of events 1
|
Other adverse events
| Measure |
DOXIL/CARBOPLATIN/BEVACIZUMAB
n=54 participants at risk
Doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Intervention.
|
|---|---|
|
General disorders
Fatigue
|
59.3%
32/54 • Number of events 32
|
|
General disorders
Mucosal Inflammation
|
14.8%
8/54 • Number of events 8
|
|
General disorders
Chest Pain
|
13.0%
7/54 • Number of events 7
|
|
General disorders
Oedema Peripheral
|
11.1%
6/54 • Number of events 6
|
|
General disorders
Pain
|
9.3%
5/54 • Number of events 5
|
|
General disorders
Pyrexia
|
9.3%
5/54 • Number of events 5
|
|
General disorders
Feeling Hot
|
5.6%
3/54 • Number of events 3
|
|
General disorders
Oedema
|
5.6%
3/54 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
57.4%
31/54 • Number of events 31
|
|
Gastrointestinal disorders
Stomatitis
|
37.0%
20/54 • Number of events 20
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
18/54 • Number of events 18
|
|
Gastrointestinal disorders
Vomiting
|
29.6%
16/54 • Number of events 16
|
|
Gastrointestinal disorders
Constipation
|
27.8%
15/54 • Number of events 15
|
|
Gastrointestinal disorders
Abdominal Pain
|
22.2%
12/54 • Number of events 12
|
|
Gastrointestinal disorders
Dyspepsia
|
9.3%
5/54 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
7.4%
4/54 • Number of events 4
|
|
Gastrointestinal disorders
Flatulence
|
7.4%
4/54 • Number of events 4
|
|
Gastrointestinal disorders
Dry Mouth
|
5.6%
3/54 • Number of events 3
|
|
Gastrointestinal disorders
Gingival Bleeding
|
5.6%
3/54 • Number of events 3
|
|
Blood and lymphatic system disorders
Anaemia
|
51.9%
28/54 • Number of events 28
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
51.9%
28/54 • Number of events 28
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.6%
23/54 • Number of events 23
|
|
Blood and lymphatic system disorders
Leukopenia
|
37.0%
20/54 • Number of events 20
|
|
Nervous system disorders
Headache
|
42.6%
23/54 • Number of events 23
|
|
Nervous system disorders
Dizziness
|
24.1%
13/54 • Number of events 13
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
11.1%
6/54 • Number of events 6
|
|
Nervous system disorders
Dysgeusia
|
9.3%
5/54 • Number of events 5
|
|
Nervous system disorders
Neuropathy Peripheral
|
7.4%
4/54 • Number of events 4
|
|
Nervous system disorders
Memory Impairment
|
5.6%
3/54 • Number of events 3
|
|
Nervous system disorders
Sinus Headache
|
5.6%
3/54 • Number of events 3
|
|
Nervous system disorders
Syncope
|
5.6%
3/54 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
51.9%
28/54 • Number of events 28
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
9/54 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.8%
8/54 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.6%
3/54 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
5.6%
3/54 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
3/54 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
27.8%
15/54 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.1%
13/54 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
13.0%
7/54 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
6/54 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
3/54 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
5.6%
3/54 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
20.4%
11/54 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.8%
8/54 • Number of events 8
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.0%
7/54 • Number of events 7
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
11.1%
6/54 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
6/54 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.4%
4/54 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.6%
3/54 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.6%
3/54 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.6%
3/54 • Number of events 3
|
|
Vascular disorders
Hypertension
|
37.0%
20/54 • Number of events 20
|
|
Vascular disorders
Flushing
|
11.1%
6/54 • Number of events 6
|
|
Vascular disorders
Hot Flush
|
5.6%
3/54 • Number of events 3
|
|
Renal and urinary disorders
Proteinuria
|
37.0%
20/54 • Number of events 20
|
|
Renal and urinary disorders
Haematuria
|
5.6%
3/54 • Number of events 3
|
|
Renal and urinary disorders
Pollakiuria
|
5.6%
3/54 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.8%
8/54 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
13.0%
7/54 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
11.1%
6/54 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
9.3%
5/54 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.3%
5/54 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
7.4%
4/54 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
7.4%
4/54 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
7.4%
4/54 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
14.8%
8/54 • Number of events 8
|
|
Psychiatric disorders
Anxiety
|
11.1%
6/54 • Number of events 6
|
|
Psychiatric disorders
Depression
|
11.1%
6/54 • Number of events 6
|
|
Infections and infestations
Urinary Tract Infection
|
14.8%
8/54 • Number of events 8
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
4/54 • Number of events 4
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.6%
3/54 • Number of events 3
|
|
Investigations
Neutrophil Count Decreased
|
9.3%
5/54 • Number of events 5
|
|
Investigations
Weight Decreased
|
7.4%
4/54 • Number of events 4
|
|
Cardiac disorders
Palpitations
|
7.4%
4/54 • Number of events 4
|
|
Cardiac disorders
Tachycardia
|
7.4%
4/54 • Number of events 4
|
|
Eye disorders
Vision Blurred
|
9.3%
5/54 • Number of events 5
|
|
Immune system disorders
Hypersensitivity
|
9.3%
5/54 • Number of events 5
|
|
Injury, poisoning and procedural complications
Contusion
|
7.4%
4/54 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60