Trial Outcomes & Findings for Trial of Vascular Endothelial Growth Factor (VEGF), Bevacizumab, in Combination With Cytotoxic Chemotherapy for Endometrial Cancer (NCT NCT00879359)

Last Updated: 2017-04-26

Results Overview

Number of patients with progression free survival measured at 6 months. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.0), as a 20% increased in the sum of the longest diameter of target lesions, or a measure increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

58 months

Results posted on

2017-04-26

Participant Flow

Participant milestones

Participant milestones
Measure	Maintenance Therapy With Bevacizumab A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m\^2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Vascular Endothelial Growth Factor (VEGF), Bevacizumab, in Combination With Cytotoxic Chemotherapy for Endometrial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Maintenance Therapy With Bevacizumab n=15 Participants A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m\^2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants
Stage (FIGO 2009) IA	4 Participants n=5 Participants
Stage (FIGO 2009) IB	1 Participants n=5 Participants
Stage (FIGO 2009) IIB	1 Participants n=5 Participants
Stage (FIGO 2009) IIIC1	1 Participants n=5 Participants
Stage (FIGO 2009) IIIC2	1 Participants n=5 Participants
Stage (FIGO 2009) IVB	7 Participants n=5 Participants
Tumor histology and grade Serous papillary	6 Participants n=5 Participants
Tumor histology and grade Endometrioid grade 2	5 Participants n=5 Participants
Tumor histology and grade Endometrioid grade 3	3 Participants n=5 Participants
Tumor histology and grade Clear cell	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 58 months

Outcome measures

Outcome measures
Measure	Maintenance With Bevacizumab n=15 Participants carboplatin, paclitaxel, and bevacizumab: All patients enrolled will receive carboplatin AUC 5 plus paclitaxel 175 mg/m2 (135 mg/m2 if prior radiation to greater than 25% of bone marrow) plus bevacizumab 15 mg/kg every 3 weeks.
Number of Participants With Progression Free Survival (PFS=Date of Progression of Disease or Death) at 6 Months Using Bevacizumab, Carboplatin, and Paclitaxel in Patients With Measurable Disease for Advanced/Recurrent Endometrial Cancer Participants with PFS at 6 months	14 Participants
Number of Participants With Progression Free Survival (PFS=Date of Progression of Disease or Death) at 6 Months Using Bevacizumab, Carboplatin, and Paclitaxel in Patients With Measurable Disease for Advanced/Recurrent Endometrial Cancer Partipants with progression at 6 months	1 Participants

SECONDARY outcome

Timeframe: 58 months

Median progression free survival measured in months. Progression of disease is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.0), as a 20% increased in the sum of the longest diameter of the target lesions, or a measurable increased in a non-target lesion, or the appearance of a new lesion.

Outcome measures

Outcome measures
Measure	Maintenance With Bevacizumab n=15 Participants carboplatin, paclitaxel, and bevacizumab: All patients enrolled will receive carboplatin AUC 5 plus paclitaxel 175 mg/m2 (135 mg/m2 if prior radiation to greater than 25% of bone marrow) plus bevacizumab 15 mg/kg every 3 weeks.
Median Progression Free Survival of This Treatment Regimen in Patients With Advanced/Recurrent Endometrial Cancer.	18 months Interval 7.0 to 58.0

SECONDARY outcome

Timeframe: 58 months

Toxicity and safety was monitored before every treatment cycle, during, and after treatment. Bevacizumab was discontinued if the following criteria was met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.

Outcome measures

Outcome measures
Measure	Maintenance With Bevacizumab n=15 Participants carboplatin, paclitaxel, and bevacizumab: All patients enrolled will receive carboplatin AUC 5 plus paclitaxel 175 mg/m2 (135 mg/m2 if prior radiation to greater than 25% of bone marrow) plus bevacizumab 15 mg/kg every 3 weeks.
Number of Participants With Adverse Events Grades 1-5 Bowel Perforation	1 participants
Number of Participants With Adverse Events Grades 1-5 Leukopenia (AE grade 1-5)	13 participants
Number of Participants With Adverse Events Grades 1-5 Neutropenia (AE Grade 1-5)	12 participants
Number of Participants With Adverse Events Grades 1-5 Thrombocytopenia (AE Grade 1-5)	9 participants
Number of Participants With Adverse Events Grades 1-5 Anemia (AE Grade 1-5)	15 participants
Number of Participants With Adverse Events Grades 1-5 Allergy/Immunology (AE Grades 1-5)	2 participants
Number of Participants With Adverse Events Grades 1-5 Alopecia (AE Grades 1-5)	10 participants
Number of Participants With Adverse Events Grades 1-5 Anorexia (AE Grades 1-5)	8 participants
Number of Participants With Adverse Events Grades 1-5 Cough (AE Grades 1-5)	4 participants
Number of Participants With Adverse Events Grades 1-5 Depression (AE Grades 1-5)	2 participants
Number of Participants With Adverse Events Grades 1-5 Diarrhea (AE Grades 1-5)	5 participants
Number of Participants With Adverse Events Grades 1-5 Dyspnea (AE Grades 1-5)	3 participants
Number of Participants With Adverse Events Grades 1-5 Epistaxis (AE Grades 1-5)	1 participants
Number of Participants With Adverse Events Grades 1-5 Fatigue (AE Grades 1-5)	12 participants
Number of Participants With Adverse Events Grades 1-5 Gastrointestinal (AE Grades 1-5)	9 participants
Number of Participants With Adverse Events Grades 1-5 Hemorrhage (AE Grades 1-5)	1 participants
Number of Participants With Adverse Events Grades 1-5 Hoarseness (AE Grades 1-5)	2 participants
Number of Participants With Adverse Events Grades 1-5 Hypercalcemia (AE Grades 1-5)	1 participants
Number of Participants With Adverse Events Grades 1-5 Infection (AE Grades 1-5)	2 participants
Number of Participants With Adverse Events Grades 1-5 Lymphatics (AE Grades 1-5)	1 participants
Number of Participants With Adverse Events Grades 1-5 Nausea (AE Grades 1-5)	6 participants
Number of Participants With Adverse Events Grades 1-5 Neurosensory (AE Grades 1-5)	6 participants
Number of Participants With Adverse Events Grades 1-5 Ocular/Visual (AE Grades 1-5)	1 participants
Number of Participants With Adverse Events Grades 1-5 Pain (AE Grades 1-5)	5 participants
Number of Participants With Adverse Events Grades 1-5 Rash (AE Grades 1-5)	3 participants
Number of Participants With Adverse Events Grades 1-5 Rhinitis (AE Grades 1-5)	1 participants
Number of Participants With Adverse Events Grades 1-5 Tinitus	1 participants
Number of Participants With Adverse Events Grades 1-5 Vomiting (AE Grades 1-5)	3 participants

Adverse Events

Maintenance Therapy With Bevacizumab

Serious events: 11 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Maintenance Therapy With Bevacizumab n=15 participants at risk A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
Blood and lymphatic system disorders Neutropenia	53.3% 8/15 • Number of events 8 • 58 months Bevacizumab was to be permanently discontinued if the following criteria were met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.
Blood and lymphatic system disorders Thrombocytopenia	6.7% 1/15 • Number of events 1 • 58 months Bevacizumab was to be permanently discontinued if the following criteria were met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.
Immune system disorders Allergy	6.7% 1/15 • Number of events 1 • 58 months Bevacizumab was to be permanently discontinued if the following criteria were met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.
Gastrointestinal disorders Gastrointestinal	6.7% 1/15 • Number of events 1 • 58 months Bevacizumab was to be permanently discontinued if the following criteria were met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.

Other adverse events

Other adverse events
Measure	Maintenance Therapy With Bevacizumab n=15 participants at risk A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
Blood and lymphatic system disorders Leukopenia	86.7% 13/15 • Number of events 13 • 58 months Bevacizumab was to be permanently discontinued if the following criteria were met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.
Blood and lymphatic system disorders Neutropenia	26.7% 4/15 • Number of events 4 • 58 months Bevacizumab was to be permanently discontinued if the following criteria were met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.
Blood and lymphatic system disorders Thrombocytopenia	53.3% 8/15 • Number of events 8 • 58 months Bevacizumab was to be permanently discontinued if the following criteria were met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.
Blood and lymphatic system disorders Anemia	100.0% 15/15 • Number of events 15 • 58 months Bevacizumab was to be permanently discontinued if the following criteria were met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.
Skin and subcutaneous tissue disorders Allopecia	66.7% 10/15 • Number of events 10 • 58 months Bevacizumab was to be permanently discontinued if the following criteria were met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.
Gastrointestinal disorders Anorexia	53.3% 8/15 • Number of events 8 • 58 months Bevacizumab was to be permanently discontinued if the following criteria were met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.
Respiratory, thoracic and mediastinal disorders Cough	26.7% 4/15 • Number of events 4 • 58 months Bevacizumab was to be permanently discontinued if the following criteria were met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.
Psychiatric disorders Depression	13.3% 2/15 • Number of events 2 • 58 months Bevacizumab was to be permanently discontinued if the following criteria were met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.
Gastrointestinal disorders Diarrhea	33.3% 5/15 • Number of events 5 • 58 months Bevacizumab was to be permanently discontinued if the following criteria were met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 3/15 • Number of events 3 • 58 months Bevacizumab was to be permanently discontinued if the following criteria were met: grade 4 hypertension, reversible posterior leukoencephalopathy syndrome or hypertensive encephalopathy, grade 4 nephritic syndrome, arterial thrombosis, symptomatic grade 4 or recurrent/worsening venous thromboembolic events after resumption of bevacizumab treatment, grade 3 hemorrhage, bowel perforation or fistula and any complete wound disruption.

Additional Information

Lynn Borzi

Cleveland Clinic

Phone: 2164453158

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place