Trial Outcomes & Findings for Phase 2 Study of Gemzar, Taxol & Avastin Combination as 1st Line Treatment for Metastatic Breast Cancer (NCT NCT00403130)
NCT ID: NCT00403130
Last Updated: 2019-02-20
Results Overview
Time-to-Progression (TTP) was assessed as the time from start of treatment to progression, as observed on radiographic scans and assessed per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for progressive disease (ie, a 5-mm absolute increase of the sum of the longest diameters of the target lesions in addition to a 20% increase in the sum of the target lesions)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
2 years
Results posted on
2019-02-20
Participant Flow
Participant milestones
| Measure |
Gemcitabine + Paclitaxel + Bevacizumab
* Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles
|
|---|---|
|
2 Years From Start of Treatment
STARTED
|
31
|
|
2 Years From Start of Treatment
COMPLETED
|
26
|
|
2 Years From Start of Treatment
NOT COMPLETED
|
5
|
|
Survival Follow-up up to 6 Years
STARTED
|
26
|
|
Survival Follow-up up to 6 Years
COMPLETED
|
16
|
|
Survival Follow-up up to 6 Years
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Gemcitabine + Paclitaxel + Bevacizumab
* Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles
|
|---|---|
|
2 Years From Start of Treatment
Not Eligible
|
3
|
|
2 Years From Start of Treatment
Lost to Follow up
|
1
|
|
2 Years From Start of Treatment
Withdrawal by Subject
|
1
|
|
Survival Follow-up up to 6 Years
Lost to Follow-up
|
10
|
Baseline Characteristics
Phase 2 Study of Gemzar, Taxol & Avastin Combination as 1st Line Treatment for Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine + Paclitaxel + Bevacizumab
n=31 Participants
* Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Disease progression was documented for 9 participants.
Time-to-Progression (TTP) was assessed as the time from start of treatment to progression, as observed on radiographic scans and assessed per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for progressive disease (ie, a 5-mm absolute increase of the sum of the longest diameters of the target lesions in addition to a 20% increase in the sum of the target lesions)
Outcome measures
| Measure |
Bevacizumab + Gemcitabine + Paclitaxel
n=9 Participants
* Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles
|
|---|---|
|
Time-to-Progression (TTP)
|
8.9 months
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Although 24 participants completed treatment, only 13 were evaluable for treatment effect.
The best overall response was recorded for each participant from randomization until disease progression/recurrence, using any increase from the smallest measurements recorded since randomization as the indicator of Progressive Disease (PD). Overall response was determined on the basis of response at the target and non-target lesions, and the appearance of new lesions, as follows. Target Nontarget New Lesions Overall Response * Complete Complete None Overall Complete Response * Complete Incomplete response/ None Overall Partial Response Stable Disease (SD) * Partial Not PD None Overall Partial Response * SD Not PD None Overall Stable Disease * PD Any Yes/No Overall PD * Any PD Yes/No Overall PD * Any Any Yes Overall PD Overall Response Rate (ORR) was assessed as the sum of the Complete Response (CR) rate and the Partial Response (PR) rate.
Outcome measures
| Measure |
Bevacizumab + Gemcitabine + Paclitaxel
n=13 Participants
* Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles
|
|---|---|
|
Response Rates
Complete Response (CR)
|
1 Participants
|
|
Response Rates
Partial Response (PR)
|
4 Participants
|
|
Response Rates
Stable Disease (SD)
|
1 Participants
|
|
Response Rates
Progressive Disease (PD)
|
7 Participants
|
|
Response Rates
Overall Response Rate (ORR)
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 yearsOverall Survival (OS) as determined by confirmed date of death. Participants without documentation as either alive or deceased as of 6 years from the start of treatment were considered lost-to-follow-up.
Outcome measures
| Measure |
Bevacizumab + Gemcitabine + Paclitaxel
n=16 Participants
* Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles
|
|---|---|
|
Overall Survival (OS), Confirmed
|
33.7 months
Interval 13.8 to 66.9
|
SECONDARY outcome
Timeframe: 6 yearsOverall Survival (OS), based on date of death or last known date alive
Outcome measures
| Measure |
Bevacizumab + Gemcitabine + Paclitaxel
n=26 Participants
* Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles
|
|---|---|
|
Overall Survival (OS), All Participants
|
14.8 months
Interval 5.0 to 66.9
|
Adverse Events
Gemcitabine + Paclitaxel + Bevacizumab
Serious events: 18 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine + Paclitaxel + Bevacizumab
n=28 participants at risk；n=26 participants at risk
* Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.4%
4/26 • Number of events 8 • 2 years
|
|
General disorders
Weakness
|
3.8%
1/26 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Acute Renal failure
|
3.8%
1/26 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Aspartate Aminotransferase
|
3.8%
1/26 • Number of events 1 • 2 years
|
|
Cardiac disorders
Peripheral arterial ischemia
|
3.8%
1/26 • Number of events 1 • 2 years
|
|
Infections and infestations
Febrile neutropenia
|
3.8%
1/26 • Number of events 1 • 2 years
|
|
Nervous system disorders
Syncope
|
3.8%
1/26 • Number of events 1 • 2 years
|
|
Cardiac disorders
Thrombosis
|
3.8%
1/26 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.5%
3/26 • Number of events 4 • 2 years
|
|
Blood and lymphatic system disorders
Epitasis
|
3.8%
1/26 • Number of events 1 • 2 years
|
|
General disorders
Pain
|
7.7%
2/26 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
3.8%
1/26 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Gemcitabine + Paclitaxel + Bevacizumab
n=28 participants at risk；n=26 participants at risk
* Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
* Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles
|
|---|---|
|
General disorders
Pain
|
14.3%
4/28 • Number of events 4 • 2 years
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
10.7%
3/28 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Alanine Aminotransferase, serum glutamic pyruvic transaminase
|
10.7%
3/28 • Number of events 6 • 2 years
|
|
Blood and lymphatic system disorders
Aspartate Aminotransferase, serum glutamic oxaloacetic transaminase
|
10.7%
3/28 • Number of events 4 • 2 years
|
|
Infections and infestations
Febrile neutropenia
|
21.4%
6/28 • Number of events 10 • 2 years
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
7/28 • Number of events 10 • 2 years
|
|
Infections and infestations
Neutropenia
|
39.3%
11/28 • Number of events 20 • 2 years
|
|
Infections and infestations
Scalp folliculitis
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Infections and infestations
Infection with normal absolute neutrophil count
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
7.1%
2/28 • Number of events 6 • 2 years
|
|
Blood and lymphatic system disorders
Hypertension
|
10.7%
3/28 • Number of events 3 • 2 years
|
|
Renal and urinary disorders
Proteinuria
|
7.1%
2/28 • Number of events 3 • 2 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
17.9%
5/28 • Number of events 10 • 2 years
|
|
Gastrointestinal disorders
Anorexia
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
2/28 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphagia
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Hypokalemia
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Nervous system disorders
Neuropathy
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Infection
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
7.1%
2/28 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
2/28 • Number of events 2 • 2 years
|
|
General disorders
Congestion
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Epistaxis
|
10.7%
3/28 • Number of events 3 • 2 years
|
|
Skin and subcutaneous tissue disorders
Erythematous
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
General disorders
Fatigue
|
10.7%
3/28 • Number of events 3 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.6%
1/28 • Number of events 2 • 2 years
|
|
Nervous system disorders
Headache
|
14.3%
4/28 • Number of events 5 • 2 years
|
|
Cardiac disorders
Heartburn
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
7.1%
2/28 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
7.1%
2/28 • Number of events 2 • 2 years
|
|
Infections and infestations
Upper respiratory infection
|
7.1%
2/28 • Number of events 2 • 2 years
|
|
Infections and infestations
Gingivitis
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Irregular menses
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
3.6%
1/28 • Number of events 1 • 2 years
|
|
Nervous system disorders
Peripheral neuropathy
|
10.7%
3/28 • Number of events 4 • 2 years
|
|
Blood and lymphatic system disorders
Thrombosis
|
7.1%
2/28 • Number of events 2 • 2 years
|
Additional Information
George Albert Fisher, MD, PhD
Stanford University Medical Center
Phone: 650-725-9057
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place