Trial Outcomes & Findings for Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma (NCT NCT00513786)
NCT ID: NCT00513786
Last Updated: 2025-03-28
Results Overview
Progressive Disease (PD) is defined at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
up to 57 months
Results posted on
2025-03-28
Participant Flow
Participant milestones
| Measure |
Carboplatin/Paclitaxel With Bevacizumab
A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles.
Carboplatin: AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
Paclitaxel: 175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
bevacizumab: 15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma
Baseline characteristics by cohort
| Measure |
Carboplatin/Paclitaxel With Bevacizumab
n=38 Participants
A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles.
Carboplatin: AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
Paclitaxel: 175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
bevacizumab: 15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 57 monthsProgressive Disease (PD) is defined at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions.
Outcome measures
| Measure |
Carboplatin/Paclitaxel With Bevacizumab
n=38 Participants
A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles.
Carboplatin: AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
Paclitaxel: 175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
bevacizumab: 15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
|
|---|---|
|
Evaluate Patients With Progression Free Survival (PFS)
|
26 months
Interval 2.0 to 57.0
|
SECONDARY outcome
Timeframe: up to 24 monthsPopulation: Two participants did not complete all 24 months of follow-up and are were not analyzed for this outcome measure.
Outcome measures
| Measure |
Carboplatin/Paclitaxel With Bevacizumab
n=36 Participants
A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles.
Carboplatin: AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
Paclitaxel: 175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
bevacizumab: 15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
|
|---|---|
|
To Estimate Overall Survival
|
69.4 percentage of participants
|
SECONDARY outcome
Timeframe: up to 24 monthsToxicities will be assessed by using the NCI Common Toxicity Criteria for Adverse Events 3.0
Outcome measures
| Measure |
Carboplatin/Paclitaxel With Bevacizumab
n=38 Participants
A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles.
Carboplatin: AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
Paclitaxel: 175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
bevacizumab: 15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
|
|---|---|
|
Number of Patients With Adverse Events as a Measure of Safety and Tolerability.
Patients with Adverse Event
|
38 participants
|
|
Number of Patients With Adverse Events as a Measure of Safety and Tolerability.
Patients with Serious Adverse Event
|
4 participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Two patients did not complete all 24 months of follow up and were not analyzed for this outcome measure.
Tumor response will be evaluated using modified RECIST criteria with the following definitions. Complete Response (CR) is disappearance of gross evidence of disease with confirmation at least 4 weeks later. Partial Response (PR) is a 30% or greater reduction in measurement of longest dimension of each lesion with confirmation at least 4 weeks later. Progressive Disease (PD) is at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions. Stable Disease (SD) is any condition not meeting the other criteria for CR, PR or PD.
Outcome measures
| Measure |
Carboplatin/Paclitaxel With Bevacizumab
n=36 Participants
A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles.
Carboplatin: AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
Paclitaxel: 175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
bevacizumab: 15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
|
|---|---|
|
Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Complete Response
|
19 Participants
|
|
Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Partial Response
|
2 Participants
|
|
Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Stable Disease
|
7 Participants
|
|
Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Progressive Disease
|
1 Participants
|
|
Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Unable to Determine
|
3 Participants
|
|
Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Zero Measurable Disease
|
4 Participants
|
Adverse Events
Carboplatin/Paclitaxel With Bevacizumab
Serious events: 4 serious events
Other events: 38 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Carboplatin/Paclitaxel With Bevacizumab
n=38 participants at risk
A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles.
Carboplatin: AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
Paclitaxel: 175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
bevacizumab: 15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
|
|---|---|
|
Injury, poisoning and procedural complications
Evisceration- fascia dehiscence
|
2.6%
1/38 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Evisceration- vaginal dehiscence
|
2.6%
1/38 • Number of events 1 • 2 years
|
|
Vascular disorders
Pulmonary embolism
|
2.6%
1/38 • Number of events 1 • 2 years
|
|
Infections and infestations
Neutropenic sepsis
|
2.6%
1/38 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Carboplatin/Paclitaxel With Bevacizumab
n=38 participants at risk
A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles.
Carboplatin: AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
Paclitaxel: 175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
bevacizumab: 15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
|
|---|---|
|
Investigations
Abnormal Creatinine
|
31.6%
12/38 • Number of events 37 • 2 years
|
|
Immune system disorders
Allergy/Immunology
|
5.3%
2/38 • Number of events 5 • 2 years
|
|
Investigations
Neutrophils/granulocytes
|
31.6%
12/38 • Number of events 35 • 2 years
|
|
Ear and labyrinth disorders
Auditory/Hearing- other
|
5.3%
2/38 • Number of events 2 • 2 years
|
|
Cardiac disorders
Cardiovascular Disorders
|
39.5%
15/38 • Number of events 37 • 2 years
|
|
Investigations
Coagulation
|
7.9%
3/38 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Constaipation
|
36.8%
14/38 • Number of events 44 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatology disorders
|
31.6%
12/38 • Number of events 39 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
21.1%
8/38 • Number of events 19 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.7%
9/38 • Number of events 19 • 2 years
|
|
Investigations
Increased Liver Enzymes
|
13.2%
5/38 • Number of events 11 • 2 years
|
|
General disorders
Fatigue
|
63.2%
24/38 • Number of events 67 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.3%
2/38 • Number of events 3 • 2 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
31.6%
12/38 • Number of events 44 • 2 years
|
|
Gastrointestinal disorders
Hemorrhage
|
7.9%
3/38 • Number of events 7 • 2 years
|
|
Infections and infestations
Infection clinically documented
|
13.2%
5/38 • Number of events 7 • 2 years
|
|
Blood and lymphatic system disorders
Lymphatics
|
10.5%
4/38 • Number of events 5 • 2 years
|
|
Gastrointestinal disorders
Mucositis/stomatis
|
15.8%
6/38 • Number of events 16 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
10.5%
4/38 • Number of events 7 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
44.7%
17/38 • Number of events 42 • 2 years
|
|
Eye disorders
Ocular/visual
|
7.9%
3/38 • Number of events 5 • 2 years
|
|
General disorders
Other constitutional toxicity
|
13.2%
5/38 • Number of events 20 • 2 years
|
|
Gastrointestinal disorders
Other GI toxicity
|
21.1%
8/38 • Number of events 27 • 2 years
|
|
Infections and infestations
Other infection toxicity
|
13.2%
5/38 • Number of events 11 • 2 years
|
|
Investigations
Other metabolic/lab toxicity
|
28.9%
11/38 • Number of events 22 • 2 years
|
|
Nervous system disorders
Other neurologic toxicity
|
18.4%
7/38 • Number of events 20 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Other pulmonary toxicity
|
10.5%
4/38 • Number of events 4 • 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
5.3%
2/38 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.9%
11/38 • Number of events 18 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
5.3%
2/38 • Number of events 2 • 2 years
|
|
Psychiatric disorders
Anxiety
|
7.9%
3/38 • Number of events 5 • 2 years
|
|
Psychiatric disorders
Depression
|
7.9%
3/38 • Number of events 4 • 2 years
|
|
Psychiatric disorders
Insomnia
|
31.6%
12/38 • Number of events 21 • 2 years
|
|
Psychiatric disorders
Mood alteration
|
15.8%
6/38 • Number of events 8 • 2 years
|
|
Nervous system disorders
Taste alteration
|
5.3%
2/38 • Number of events 2 • 2 years
|
|
General disorders
Pain, not specified
|
50.0%
19/38 • Number of events 46 • 2 years
|
|
Nervous system disorders
Sensory neuropathy
|
31.6%
12/38 • Number of events 39 • 2 years
|
|
Investigations
Platelet count decreased
|
10.5%
4/38 • Number of events 14 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
13.2%
5/38 • Number of events 9 • 2 years
|
|
Investigations
White blood cell decreased
|
44.7%
17/38 • Number of events 50 • 2 years
|
Additional Information
Dr. David O'Malley
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-3873
Email: David.O'[email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place