Trial Outcomes & Findings for Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes (NCT NCT00887809)
NCT ID: NCT00887809
Last Updated: 2016-01-25
Results Overview
Overall Objective Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
6 months
Results posted on
2016-01-25
Participant Flow
Participant milestones
| Measure |
Gemcitabine, Docetaxel, Bevacizumab
Gemcitabine, Docetaxel, Bevacizumab
|
Gemcitabine, Docetaxel, Placebo
Gemcitabine, Docetaxel, Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
10
|
|
Overall Study
COMPLETED
|
33
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Gemcitabine, Docetaxel, Bevacizumab
Gemcitabine, Docetaxel, Bevacizumab
|
Gemcitabine, Docetaxel, Placebo
Gemcitabine, Docetaxel, Placebo
|
|---|---|---|
|
Overall Study
Patient Not Treated
|
3
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes
Baseline characteristics by cohort
| Measure |
Gemcitabine, Docetaxel, Bevacizumab
n=37 Participants
Gemcitabine, Docetaxel, Bevacizumab
|
Gemcitabine, Docetaxel, Placebo
n=10 Participants
Gemcitabine, Docetaxel, Placebo
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOverall Objective Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Outcome measures
| Measure |
Gemcitabine, Docetaxel, Bevacizumab
n=33 Participants
Gemcitabine, Docetaxel, Bevacizumab
|
Gemcitabine, Docetaxel, Placebo
n=10 Participants
Gemcitabine, Docetaxel, Placebo
|
|---|---|---|
|
Overall Objective Response
Complete Response (CR)
|
0 participants
|
1 participants
|
|
Overall Objective Response
Partial Response (PR)
|
9 participants
|
1 participants
|
|
Overall Objective Response
Stable Disease (SD)
|
23 participants
|
7 participants
|
|
Overall Objective Response
Progression of Disease (POD)
|
1 participants
|
1 participants
|
Adverse Events
Gemcitabine, Docetaxel, Bevacizumab
Serious events: 12 serious events
Other events: 33 other events
Deaths: 0 deaths
Gemcitabine, Docetaxel, Placebo
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine, Docetaxel, Bevacizumab
n=37 participants at risk
Gemcitabine, Docetaxel, Bevacizumab
|
Gemcitabine, Docetaxel, Placebo
n=10 participants at risk
Gemcitabine, Docetaxel, Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/37
|
20.0%
2/10 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding, other
|
2.7%
1/37 • Number of events 1
|
0.00%
0/10
|
|
Cardiac disorders
Hypertension
|
2.7%
1/37 • Number of events 1
|
0.00%
0/10
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.00%
0/37
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/37
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Confusion
|
0.00%
0/37
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Death not assoc w CTCAE term- Death NOS
|
2.7%
1/37 • Number of events 1
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/37
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Febrile neutropenia
|
0.00%
0/37
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Infection normal Absolute Neutrophil Counts/grade 1/2 neutrophils-Cellulitis(skin)
|
2.7%
1/37 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Infection normal Absolute Neutrophil Counts/grade 1/2 neutrophils-Pneumonia(lung)
|
2.7%
1/37 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Infection unknown Absolute Neutrophil Counts -Pneumonia(lung)
|
0.00%
0/37
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Infection, other
|
5.4%
2/37 • Number of events 2
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Leukocytes
|
0.00%
0/37
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Pain - Chest/thorax NOS
|
2.7%
1/37 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Pain - Extremity-limb
|
2.7%
1/37 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Pain - Pelvis
|
0.00%
0/37
|
20.0%
2/10 • Number of events 2
|
|
Blood and lymphatic system disorders
Platelets
|
2.7%
1/37 • Number of events 1
|
20.0%
2/10 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/upper respiratory - Other
|
0.00%
0/37
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
2.7%
1/37 • Number of events 1
|
0.00%
0/10
|
|
Renal and urinary disorders
Renal/Genitourinary-Other
|
0.00%
0/37
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Syncope (fainting)
|
2.7%
1/37 • Number of events 1
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis/thrombus/embolism
|
2.7%
1/37 • Number of events 1
|
0.00%
0/10
|
|
Cardiac disorders
Valvular heart disease
|
2.7%
1/37 • Number of events 1
|
0.00%
0/10
|
Other adverse events
| Measure |
Gemcitabine, Docetaxel, Bevacizumab
n=37 participants at risk
Gemcitabine, Docetaxel, Bevacizumab
|
Gemcitabine, Docetaxel, Placebo
n=10 participants at risk
Gemcitabine, Docetaxel, Placebo
|
|---|---|---|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
51.4%
19/37 • Number of events 19
|
60.0%
6/10 • Number of events 6
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
13.5%
5/37 • Number of events 5
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
ALT, SGPT
|
27.0%
10/37 • Number of events 10
|
30.0%
3/10 • Number of events 3
|
|
Blood and lymphatic system disorders
AST, SGOT
|
27.0%
10/37 • Number of events 10
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
8.1%
3/37 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/37
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/37
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Edema: limb
|
8.1%
3/37 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
8.1%
3/37 • Number of events 3
|
20.0%
2/10 • Number of events 2
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
45.9%
17/37 • Number of events 17
|
40.0%
4/10 • Number of events 4
|
|
Metabolism and nutrition disorders
Glucose, low (hypoglycemia)
|
8.1%
3/37 • Number of events 3
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Hemoglobin
|
73.0%
27/37 • Number of events 27
|
80.0%
8/10 • Number of events 8
|
|
Infections and infestations
Infection normal Absolute Neutrophil Counts/grade 1/2 neutrophils-Pneumonia(lung)
|
0.00%
0/37
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
International normalized ratio (INR)
|
0.00%
0/37
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
54.1%
20/37 • Number of events 20
|
50.0%
5/10 • Number of events 5
|
|
Blood and lymphatic system disorders
Lymphopenia
|
43.2%
16/37 • Number of events 16
|
60.0%
6/10 • Number of events 6
|
|
Metabolism and nutrition disorders
Magnesium, high (hypermagnesemia)
|
5.4%
2/37 • Number of events 2
|
0.00%
0/10
|
|
General disorders
Mucositis (Clincal exam)- Oral cavity
|
8.1%
3/37 • Number of events 3
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
59.5%
22/37 • Number of events 22
|
50.0%
5/10 • Number of events 5
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
29.7%
11/37 • Number of events 11
|
30.0%
3/10 • Number of events 3
|
|
Blood and lymphatic system disorders
Platelets
|
24.3%
9/37 • Number of events 9
|
30.0%
3/10 • Number of events 3
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
8.1%
3/37 • Number of events 3
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium, low (hypokalemia)
|
10.8%
4/37 • Number of events 4
|
20.0%
2/10 • Number of events 2
|
|
Blood and lymphatic system disorders
Partial thromboplastin time (PTT)
|
0.00%
0/37
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
0.00%
0/37
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
5.4%
2/37 • Number of events 2
|
20.0%
2/10 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place