Trial Outcomes & Findings for Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer (NCT NCT00361231)
NCT ID: NCT00361231
Last Updated: 2017-02-07
Results Overview
To assess the median progression free survival in patients with BTC on GEMOX-B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition, death in the absence of radiological disease progression was also categorized as progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
2 years
Results posted on
2017-02-07
Participant Flow
Participant milestones
| Measure |
Bevacizumab, Gemcitabine, Oxaliplatin
* The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
* Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
* Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Bevacizumab, Gemcitabine, Oxaliplatin
* The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
* Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
* Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
|
|---|---|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Symptomatic deterioration
|
5
|
|
Overall Study
Radiographic disease progression
|
16
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Adverse Event
|
6
|
Baseline Characteristics
Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Biliary Tract and Gallbladder Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab, Gemcitabine, Oxaliplatin
n=35 Participants
* The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
* Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
* Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Gender
Female
|
14 Participants
n=5 Participants
|
|
Gender
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTo assess the median progression free survival in patients with BTC on GEMOX-B. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. In addition, death in the absence of radiological disease progression was also categorized as progression.
Outcome measures
| Measure |
Bevacizumab, Gemcitabine, Oxaliplatin
n=35 Participants
* The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of studytreatment.
* Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
* Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Oxaliplatin
|
|---|---|
|
Median Progression Free Survival
|
7.0 months
Interval 5.3 to 10.3
|
SECONDARY outcome
Timeframe: 2 yearsTo assess the overall response rate of GEMOX-B in patients with advanced BTC. Response rate is determined through Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Bevacizumab, Gemcitabine, Oxaliplatin
n=35 Participants
* The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of studytreatment.
* Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
* Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Oxaliplatin
|
|---|---|
|
Overall Response Rate
|
0 percentage of participants
|
Adverse Events
Bevacizumab, Gemcitabine, Oxaliplatin
Serious events: 12 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab, Gemcitabine, Oxaliplatin
n=35 participants at risk
* The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
* Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
* Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side eff
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 Dyspnea
|
2.9%
1/35 • May 17, 2006 and December 5, 2007
|
|
Nervous system disorders
Grade 4 confusion
|
5.7%
2/35 • May 17, 2006 and December 5, 2007
|
|
Investigations
Grade 3 Bilirubin
|
2.9%
1/35 • May 17, 2006 and December 5, 2007
|
|
General disorders
Death within 30 days
|
2.9%
1/35 • May 17, 2006 and December 5, 2007
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.9%
1/35 • May 17, 2006 and December 5, 2007
|
|
Nervous system disorders
Grade 4 Cognitive disturbance
|
2.9%
1/35 • May 17, 2006 and December 5, 2007
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 Pulmonary embolism
|
2.9%
1/35 • May 17, 2006 and December 5, 2007
|
|
Blood and lymphatic system disorders
Absolute Neutrophil Count
|
5.7%
2/35 • May 17, 2006 and December 5, 2007
|
|
Metabolism and nutrition disorders
Grade 4 Hypophosphatemia
|
2.9%
1/35 • May 17, 2006 and December 5, 2007
|
|
Blood and lymphatic system disorders
Grade 4 lymphopenia
|
2.9%
1/35 • May 17, 2006 and December 5, 2007
|
|
General disorders
Grade 4 fatigue
|
5.7%
2/35 • May 17, 2006 and December 5, 2007
|
|
Blood and lymphatic system disorders
Grade 3 Wound dehiscence
|
2.9%
1/35 • May 17, 2006 and December 5, 2007
|
|
Infections and infestations
Grade 3 infection, wound
|
2.9%
1/35 • May 17, 2006 and December 5, 2007
|
|
General disorders
Grade 3 Hypoxia
|
2.9%
1/35 • May 17, 2006 and December 5, 2007
|
|
Gastrointestinal disorders
Grade 3 abdominal pain
|
2.9%
1/35 • May 17, 2006 and December 5, 2007
|
|
Infections and infestations
Grade 4 Sepsis
|
2.9%
1/35 • May 17, 2006 and December 5, 2007
|
|
Cardiac disorders
Acute myocardial infarction
|
2.9%
1/35 • May 17, 2006 and December 5, 2007
|
Other adverse events
| Measure |
Bevacizumab, Gemcitabine, Oxaliplatin
n=35 participants at risk
* The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.
* Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.
* Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.
Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.
Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side eff
|
|---|---|
|
Blood and lymphatic system disorders
Leucopenia
|
68.6%
24/35 • May 17, 2006 and December 5, 2007
|
|
Blood and lymphatic system disorders
Neutropenia
|
60.0%
21/35 • May 17, 2006 and December 5, 2007
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
74.3%
26/35 • May 17, 2006 and December 5, 2007
|
|
Blood and lymphatic system disorders
Anaemia
|
74.3%
26/35 • May 17, 2006 and December 5, 2007
|
|
Blood and lymphatic system disorders
Lymphopenia
|
42.9%
15/35 • May 17, 2006 and December 5, 2007
|
|
General disorders
Fatigue
|
82.9%
29/35 • May 17, 2006 and December 5, 2007
|
|
Nervous system disorders
Neuropathy
|
80.0%
28/35 • May 17, 2006 and December 5, 2007
|
|
Gastrointestinal disorders
Raised AST
|
80.0%
28/35 • May 17, 2006 and December 5, 2007
|
|
Gastrointestinal disorders
Nausea
|
77.1%
27/35 • May 17, 2006 and December 5, 2007
|
|
Gastrointestinal disorders
Raised ALT
|
74.3%
26/35 • May 17, 2006 and December 5, 2007
|
|
Gastrointestinal disorders
Constipation
|
60.0%
21/35 • May 17, 2006 and December 5, 2007
|
|
Metabolism and nutrition disorders
Anorexia
|
57.1%
20/35 • May 17, 2006 and December 5, 2007
|
|
Gastrointestinal disorders
Raised Alkaline phosphatase
|
51.4%
18/35 • May 17, 2006 and December 5, 2007
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
15/35 • May 17, 2006 and December 5, 2007
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
14/35 • May 17, 2006 and December 5, 2007
|
|
General disorders
Fever
|
34.3%
12/35 • May 17, 2006 and December 5, 2007
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
31.4%
11/35 • May 17, 2006 and December 5, 2007
|
|
Metabolism and nutrition disorders
Weight loss
|
28.6%
10/35 • May 17, 2006 and December 5, 2007
|
|
Gastrointestinal disorders
Abdominal pain
|
25.7%
9/35 • May 17, 2006 and December 5, 2007
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.7%
9/35 • May 17, 2006 and December 5, 2007
|
|
Gastrointestinal disorders
Stomatitis
|
20.0%
7/35 • May 17, 2006 and December 5, 2007
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.0%
7/35 • May 17, 2006 and December 5, 2007
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.0%
7/35 • May 17, 2006 and December 5, 2007
|
|
Skin and subcutaneous tissue disorders
Acne rash
|
20.0%
7/35 • May 17, 2006 and December 5, 2007
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
20.0%
7/35 • May 17, 2006 and December 5, 2007
|
|
Immune system disorders
Allergic reaction
|
17.1%
6/35 • May 17, 2006 and December 5, 2007
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
5/35 • May 17, 2006 and December 5, 2007
|
|
General disorders
Epistaxis
|
45.7%
16/35 • May 17, 2006 and December 5, 2007
|
|
Cardiac disorders
Hypertension
|
42.9%
15/35 • May 17, 2006 and December 5, 2007
|
|
Nervous system disorders
Headache
|
37.1%
13/35 • May 17, 2006 and December 5, 2007
|
|
Metabolism and nutrition disorders
Proteinuria
|
25.7%
9/35 • May 17, 2006 and December 5, 2007
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place