Trial Outcomes & Findings for Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (NCT NCT00588237)

NCT ID: NCT00588237

Last Updated: 2016-01-20

Results Overview

as determined by the GOG RECIST criteria

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

2 years

Results posted on

2016-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients Paclitaxel, Cisplatin, Bevacizumab
Overall Study STARTED	42
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	All Patients Paclitaxel, Cisplatin, Bevacizumab
Overall Study Evaluable for toxicity only	3
Overall Study Patien not treated	1

Baseline Characteristics

Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=42 Participants Paclitaxel, Cisplatin, Bevacizumab
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Sex: Female, Male Female	42 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 2 years

as determined by the GOG RECIST criteria

Outcome measures

Outcome measures
Measure	All Patients n=38 Participants Paclitaxel, Cisplatin, Bevacizumab
Overall Objective Response Complete Response (CR)	10 participants
Overall Objective Response Partial Response (PR)	13 participants
Overall Objective Response Progression Free (P-Free)	11 participants
Overall Objective Response Stable Disease (SD)	4 participants

Adverse Events

All Patients

Serious events: 20 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Patients n=42 participants at risk Paclitaxel, Cisplatin, Bevacizumab
Blood and lymphatic system disorders ALT, SGPT	2.4% 1/42 • Number of events 1
Blood and lymphatic system disorders AST, SGOT	2.4% 1/42 • Number of events 1
Metabolism and nutrition disorders Alkaline phosphatase	2.4% 1/42 • Number of events 1
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	2.4% 1/42 • Number of events 1
General disorders Dehydration	2.4% 1/42 • Number of events 2
General disorders Fatigue (asthenia, lethargy, malaise)	2.4% 1/42 • Number of events 1
General disorders Febrile neutropenia	2.4% 1/42 • Number of events 1
Musculoskeletal and connective tissue disorders Fracture	2.4% 1/42 • Number of events 1
Blood and lymphatic system disorders Hemoglobin	2.4% 1/42 • Number of events 1
Cardiac disorders Hypertension	7.1% 3/42 • Number of events 3
Cardiac disorders Hypotension	2.4% 1/42 • Number of events 1
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other	2.4% 1/42 • Number of events 1
Gastrointestinal disorders Nausea	7.1% 3/42 • Number of events 3
Gastrointestinal disorders Necrosis, GI- Small Bowel NOS	2.4% 1/42 • Number of events 1
Nervous system disorders Neurology - Other	2.4% 1/42 • Number of events 1
Gastrointestinal disorders Obstruction, GI- Small bowel NOS	9.5% 4/42 • Number of events 4
General disorders Pain - Abdomen NOS	4.8% 2/42 • Number of events 2
General disorders Pain - Back	2.4% 1/42 • Number of events 1
General disorders Pain - Head/headache	2.4% 1/42 • Number of events 1
Gastrointestinal disorders Perforation, GI- Colon	2.4% 1/42 • Number of events 1
Metabolism and nutrition disorders Potassium, low (hypokalemia)	2.4% 1/42 • Number of events 1
Metabolism and nutrition disorders Sodium, low (hyponatremia)	2.4% 1/42 • Number of events 1
Respiratory, thoracic and mediastinal disorders Thrombosis/thrombus/embolism	2.4% 1/42 • Number of events 1
Nervous system disorders Vasovagal episode	7.1% 3/42 • Number of events 3
Gastrointestinal disorders Vomiting	4.8% 2/42 • Number of events 2
General disorders Wound complication, non-infectious	2.4% 1/42 • Number of events 1

Other adverse events

Other adverse events
Measure	All Patients n=42 participants at risk Paclitaxel, Cisplatin, Bevacizumab
Metabolism and nutrition disorders Albumin, low (hypoalbuminemia)	11.9% 5/42 • Number of events 5
Metabolism and nutrition disorders ALT, SGPT	14.3% 6/42 • Number of events 6
Metabolism and nutrition disorders AST, SGOT	7.1% 3/42 • Number of events 3
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	9.5% 4/42 • Number of events 4
Gastrointestinal disorders Constipation	31.0% 13/42 • Number of events 13
Metabolism and nutrition disorders Creatinine	14.3% 6/42 • Number of events 6
Gastrointestinal disorders Diarrhea	9.5% 4/42 • Number of events 4
Nervous system disorders Dizziness	7.1% 3/42 • Number of events 3
General disorders Fatigue (asthenia, lethargy, malaise)	71.4% 30/42 • Number of events 30
Metabolism and nutrition disorders Glucose, high (hyperglycemia)	78.6% 33/42 • Number of events 33
Blood and lymphatic system disorders Hemoglobin	64.3% 27/42 • Number of events 27
Cardiac disorders Hypertension	23.8% 10/42 • Number of events 10
Cardiac disorders Hypotension	9.5% 4/42 • Number of events 4
Blood and lymphatic system disorders Leukocytes (total WBC)	47.6% 20/42 • Number of events 20
Blood and lymphatic system disorders Lymphopenia	23.8% 10/42 • Number of events 10
Metabolism and nutrition disorders Magnesium, low (hypomagnesemia)	21.4% 9/42 • Number of events 9
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other	31.0% 13/42 • Number of events 13
Gastrointestinal disorders Nausea	35.7% 15/42 • Number of events 15
Nervous system disorders Neuropathy: sensory	19.0% 8/42 • Number of events 8
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	57.1% 24/42 • Number of events 24
Gastrointestinal disorders Obstruction, GI- Small bowel NOS	9.5% 4/42 • Number of events 4
General disorders Pain - Abdomen NOS	31.0% 13/42 • Number of events 13
General disorders Pain - Back	7.1% 3/42 • Number of events 3
General disorders Pain - Head/headache	9.5% 4/42 • Number of events 4
Musculoskeletal and connective tissue disorders Pain - Joint	23.8% 10/42 • Number of events 10
Blood and lymphatic system disorders Partial thromboplastin time (PTT)	9.5% 4/42 • Number of events 4
Blood and lymphatic system disorders Platelets	7.1% 3/42 • Number of events 3
Metabolism and nutrition disorders Potassium, high (hyperkalemia)	11.9% 5/42 • Number of events 5
Metabolism and nutrition disorders Potassium, low (hypokalemia)	9.5% 4/42 • Number of events 4
Blood and lymphatic system disorders Prothrombin time international normalized ratio (INR)	7.1% 3/42 • Number of events 3
Skin and subcutaneous tissue disorders Rash/desquamation	7.1% 3/42 • Number of events 3
Skin and subcutaneous tissue disorders Rash: erythema multiforme	9.5% 4/42 • Number of events 4
Metabolism and nutrition disorders Sodium, low (hyponatremia)	14.3% 6/42 • Number of events 6
Ear and labyrinth disorders Tinnitus	14.3% 6/42 • Number of events 6
Nervous system disorders Vasovagal episode	11.9% 5/42 • Number of events 5
Gastrointestinal disorders Vomiting	26.2% 11/42 • Number of events 11
General disorders Weight gain	14.3% 6/42 • Number of events 6

Additional Information

Dr. Jason Konner

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place