Trial Outcomes & Findings for A Study of Biweekly Gemcitabine, Paclitaxel, and Avastin in Patients With Metastatic Breast Cancer (NCT NCT00618826)
NCT ID: NCT00618826
Last Updated: 2017-04-14
Results Overview
Time from study entry to disease progression or death
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
maximum 50 months
Results posted on
2017-04-14
Participant Flow
Participant milestones
| Measure |
Paclitaxel + Gemcitabine + Avastin
Treatment administered once every 2 weeks, 1 cycle will consist of 14 days.
Paclitaxel (administered first) - Patients will be pre-medicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.
Gemcitabine (given after Paclitaxel) - Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.
Avastin - 10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Paclitaxel + Gemcitabine + Avastin
Treatment administered once every 2 weeks, 1 cycle will consist of 14 days.
Paclitaxel (administered first) - Patients will be pre-medicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.
Gemcitabine (given after Paclitaxel) - Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.
Avastin - 10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Study of Biweekly Gemcitabine, Paclitaxel, and Avastin in Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment Period
n=14 Participants
Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.
Paclitaxel: Patients will be premedicated with dexamethasone and diphenhydramine hydrochloride. Patients will received 150mg of paclitaxel via IV over 120 mins.
Gemcitabine: Patients will receive 1500mg of Gemcitabine via IV over 30-60 minutes. Gemcitabine will be given after Paclitaxel.
Avastin: 10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions.
|
|---|---|
|
Age, Continuous
|
53.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 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
|
0 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: maximum 50 monthsTime from study entry to disease progression or death
Outcome measures
| Measure |
Treatment
n=13 Participants
Paclitaxel / Gemcitabine
|
|---|---|
|
Progression-free Survival
|
43 months
Interval 7.0 to 45.0
|
SECONDARY outcome
Timeframe: maximum 50 monthsPopulation: patients with measurable disease
Per 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 |
Treatment
n=13 Participants
Paclitaxel / Gemcitabine
|
|---|---|
|
Overall Response Rate
|
0.46 proportion of participants
Interval 0.19 to 0.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 yearsproportion of participants surviving 3 years
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of studytoxicities recorded using CTCAE definitions
Outcome measures
Outcome data not reported
Adverse Events
Treatment Period
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Period
n=14 participants at risk
Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
14.3%
2/14 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.1%
1/14 • Number of events 1
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
7.1%
1/14 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
14.3%
2/14 • Number of events 2
|
|
Cardiac disorders
Hypotension
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
14.3%
2/14 • Number of events 2
|
|
General disorders
Rigors/chills
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify,_)
|
7.1%
1/14 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils-Skin (cellulitis)
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC - Bronchus
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC - Lung (pneumonia)
|
7.1%
1/14 • Number of events 3
|
|
Infections and infestations
Infection with unknown ANC - Upper airway NOS
|
7.1%
1/14 • Number of events 1
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
7.1%
1/14 • Number of events 1
|
|
Investigations
GGT (gamma-Glutamyl transpeptidase)
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Glucose, serum-high (hyperglycemia)
|
21.4%
3/14 • Number of events 3
|
|
Investigations
Potassium, serum-high (hyperkalemia)
|
7.1%
1/14 • Number of events 2
|
|
Nervous system disorders
Syncope (fainting)
|
7.1%
1/14 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
7.1%
1/14 • Number of events 2
|
|
Nervous system disorders
Neuropathy: sensory
|
14.3%
2/14 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain-Extremity-limb
|
21.4%
3/14 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain-Joint
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain-Muscle
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain-Pain NOS
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain-Other (Specify,_)
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
21.4%
3/14 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
7.1%
1/14 • Number of events 1
|
Other adverse events
| Measure |
Treatment Period
n=14 participants at risk
Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle.
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
7.1%
1/14 • Number of events 1
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
28.6%
4/14 • Number of events 5
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Specify,_)
|
7.1%
1/14 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
78.6%
11/14 • Number of events 16
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
21.4%
3/14 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphopenia
|
21.4%
3/14 • Number of events 6
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
7.1%
1/14 • Number of events 2
|
|
Blood and lymphatic system disorders
Platelets
|
71.4%
10/14 • Number of events 13
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia-Sinus tachycardia
|
7.1%
1/14 • Number of events 1
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia-Supraventricular tachycardia
|
7.1%
1/14 • Number of events 1
|
|
Cardiac disorders
Hypertension
|
35.7%
5/14 • Number of events 5
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy (e.g., thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS])
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Constitutional Symptoms-Other(Specify,_)
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
85.7%
12/14 • Number of events 26
|
|
General disorders
Fever (in the absense of neutropenia is defined as ANC <1.0 x10e9/L)
|
28.6%
4/14 • Number of events 5
|
|
General disorders
Edema: limb-1
|
21.4%
3/14 • Number of events 3
|
|
General disorders
Rigors/chills
|
28.6%
4/14 • Number of events 4
|
|
General disorders
Sweating (diaphoresis)
|
14.3%
2/14 • Number of events 3
|
|
Investigations
Weight loss
|
35.7%
5/14 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
7.1%
1/14 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other (Specify,_)
|
21.4%
3/14 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
2/14 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
42.9%
6/14 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
21.4%
3/14 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
7.1%
1/14 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
14.3%
2/14 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash:erythema multiforme (e.g., Steven-Johnson syndrome, toxic epidermal necrolysis)
|
14.3%
2/14 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
14.3%
2/14 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
7.1%
1/14 • Number of events 1
|
|
Endocrine disorders
Hot flashes/flushes
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
35.7%
5/14 • Number of events 7
|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
6/14 • Number of events 7
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal- Other (Specify,_)
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)-Oral cavity
|
28.6%
4/14 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
71.4%
10/14 • Number of events 15
|
|
Gastrointestinal disorders
Vomiting
|
57.1%
8/14 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage,pulmonary/upper respiratory-Nose
|
50.0%
7/14 • Number of events 8
|
|
Gastrointestinal disorders
Hemorrhage/Bleeding - Other (Specify,_)
|
7.1%
1/14 • Number of events 1
|
|
Vascular disorders
Hematoma
|
7.1%
1/14 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhage, GI-Varices (rectal)
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils-Bronchus
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils-Oral cavity-gums (gingivitis)
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC-Bronchus
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC-Nose
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC-Paranasal
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC-Pharynx
|
14.3%
2/14 • Number of events 2
|
|
Infections and infestations
Infection with unknown ANC-Skin (cellulitis)
|
14.3%
2/14 • Number of events 3
|
|
Infections and infestations
Infection with unknown ANC-Upper airway NOS
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC-Urinary tract NOS
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infection with unknown ANC-Wound
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Edema: head and neck
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Edema:limb
|
21.4%
3/14 • Number of events 3
|
|
Vascular disorders
Lymphedema-related fibrosis
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Albumin, serum-low (hypoalbuminemia)
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Alkaline phosphatase
|
35.7%
5/14 • Number of events 6
|
|
Investigations
ALT,SGPT (serum glutamic pyruvic transaminase)
|
35.7%
5/14 • Number of events 7
|
|
Investigations
AST,SGOT (serum glutamic oxaloacetic transaminase)
|
42.9%
6/14 • Number of events 6
|
|
Investigations
Bilirubin(hyperbilirubinemia)
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Calcium, serum-high (hypercalcemia)
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Calcium, serum-low (hypocalcemia)
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Creatinine
|
14.3%
2/14 • Number of events 3
|
|
Investigations
Glucose, serum-high (hyperglycemia)
|
85.7%
12/14 • Number of events 23
|
|
Investigations
Glucose, serum-low (hypoglycemia)
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Magnesium, serum-low (hypomagnesemia)
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Metabolic/Laboratory - Other (Specify,_)
|
14.3%
2/14 • Number of events 2
|
|
Investigations
Potassium, serum-high (hyperkalemia)
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Potassium, serum-low (hypokalemia)
|
7.1%
1/14 • Number of events 1
|
|
Investigations
Proteinuria
|
50.0%
7/14 • Number of events 16
|
|
Investigations
Sodium, serum-low (hyponatremia)
|
14.3%
2/14 • Number of events 2
|
|
Investigations
Uric acid, serum-high (hyperuricemia)
|
14.3%
2/14 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Mood alteration-Anxiety
|
21.4%
3/14 • Number of events 3
|
|
Nervous system disorders
Mood alteration-Depression
|
14.3%
2/14 • Number of events 2
|
|
Nervous system disorders
Neurology- Other(Specify,_)
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Neuropathy: motor
|
7.1%
1/14 • Number of events 1
|
|
Nervous system disorders
Neuropathy: sensory
|
71.4%
10/14 • Number of events 19
|
|
Eye disorders
Dry eye syndrome
|
7.1%
1/14 • Number of events 1
|
|
Eye disorders
Ophthalmoplegia/diplopia (double vision)
|
7.1%
1/14 • Number of events 1
|
|
Eye disorders
Vision-blurred vision
|
28.6%
4/14 • Number of events 4
|
|
Eye disorders
Vision-flashing lights/floaters
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain-Back
|
28.6%
4/14 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Pain-Bone
|
21.4%
3/14 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain-Chest wall
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infection
|
7.1%
1/14 • Number of events 1
|
|
Ear and labyrinth disorders
Pain-External ear
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain-Extremity-limb
|
35.7%
5/14 • Number of events 6
|
|
General disorders
Pain-Face
|
7.1%
1/14 • Number of events 1
|
|
General disorders
Pain-Head/headache
|
21.4%
3/14 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain-Joint
|
28.6%
4/14 • Number of events 4
|
|
General disorders
Pain
|
7.1%
1/14 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain-Muscle
|
21.4%
3/14 • Number of events 3
|
|
General disorders
Pain-Pain NOS
|
42.9%
6/14 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Pain-Throat/pharynx/larynx
|
21.4%
3/14 • Number of events 3
|
|
General disorders
Pain-Other (Specify,_)
|
7.1%
1/14 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm,wheezing
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.9%
6/14 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
28.6%
4/14 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
|
35.7%
5/14 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify,_)
|
14.3%
2/14 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g. hoarseness, loss or alteration in voice, laryngitis)
|
7.1%
1/14 • Number of events 1
|
|
Renal and urinary disorders
Incontinence, urinary
|
7.1%
1/14 • Number of events 1
|
|
Renal and urinary disorders
Renal/Genitourinary-Other(Specify,_)
|
14.3%
2/14 • Number of events 3
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
7.1%
1/14 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal mucositis
|
7.1%
1/14 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place