Trial Outcomes & Findings for Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Locally Advanced Bladder Cancer (NCT NCT00585689)
NCT ID: NCT00585689
Last Updated: 2015-11-30
Results Overview
The rate of pathologic complete response (pT0) following three 21 day cycles of neoadjuvant ABI-007, carboplatin and gemcitabine was determined.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
63 days (post 3 cycles)
Results posted on
2015-11-30
Participant Flow
Participant milestones
| Measure |
Neoadjuvant ABI-007, Carboplatin, and Gemcitabine
Neoadjuvant ABI-007 (260 mg/m\^2) on day 1, Carboplatin (Target AUC \[Area under the curve\] =5) on day 1, and Gemcitabine (800 mg\^m2) on days 1 and 8, every 21 days.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Neoadjuvant ABI-007, Carboplatin, and Gemcitabine
Neoadjuvant ABI-007 (260 mg/m\^2) on day 1, Carboplatin (Target AUC \[Area under the curve\] =5) on day 1, and Gemcitabine (800 mg\^m2) on days 1 and 8, every 21 days.
|
|---|---|
|
Overall Study
Received different ABI-007 schedule
|
3
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Patient Declined Surgery
|
1
|
|
Overall Study
Patient had unresectable disease
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Locally Advanced Bladder Cancer
Baseline characteristics by cohort
| Measure |
Neoadjuvant ABI-007, Carboplatin, and Gemcitabine
n=29 Participants
Neoadjuvant ABI-007 (260 mg/m\^2) on day 1, Carboplatin (Target AUC \[Area under the curve\] =5) on day 1, and Gemcitabine (800 mg\^m2) on days 1 and 8, every 21 days.
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Performance Status (ECOG)
0
|
17 participants
n=5 Participants
|
|
Performance Status (ECOG)
1
|
12 participants
n=5 Participants
|
|
Clinical Disease Stage
T2N0
|
18 participants
n=5 Participants
|
|
Clinical Disease Stage
T2N1
|
2 participants
n=5 Participants
|
|
Clinical Disease Stage
T2N2
|
1 participants
n=5 Participants
|
|
Clinical Disease Stage
T3N0
|
6 participants
n=5 Participants
|
|
Clinical Disease Stage
T4N0
|
2 participants
n=5 Participants
|
|
Hydronephrosis Present
Yes
|
8 participants
n=5 Participants
|
|
Hydronephrosis Present
No
|
21 participants
n=5 Participants
|
|
Angiolymphatic Invasion Present
Yes
|
9 participants
n=5 Participants
|
|
Angiolymphatic Invasion Present
No
|
20 participants
n=5 Participants
|
|
Adjacent Carcinoma in Situ Present
Yes
|
16 participants
n=5 Participants
|
|
Adjacent Carcinoma in Situ Present
No
|
13 participants
n=5 Participants
|
|
Mixed Histological Features Present
70% Plasmacytoid, 5% Sarcomatoid
|
1 participants
n=5 Participants
|
|
Mixed Histological Features Present
10% Plasmacytoid, 10% Signet Ring
|
1 participants
n=5 Participants
|
|
Mixed Histological Features Present
5% Squamous
|
1 participants
n=5 Participants
|
|
Mixed Histological Features Present
10% Spindle
|
1 participants
n=5 Participants
|
|
Mixed Histological Features Present
20% Glandular
|
1 participants
n=5 Participants
|
|
Mixed Histological Features Present
Nested
|
3 participants
n=5 Participants
|
|
Mixed Histological Features Present
Micropapillary
|
1 participants
n=5 Participants
|
|
Mixed Histological Features Present
Micropapillary and Nested
|
1 participants
n=5 Participants
|
|
Mixed Histological Features Present
None
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 63 days (post 3 cycles)Population: 29 patients were enrolled. 26 of the 29 patients received the planned 3 cycles. 22 of the 26 patients had a cystectomy and were evaluable for the primary endpoint.
The rate of pathologic complete response (pT0) following three 21 day cycles of neoadjuvant ABI-007, carboplatin and gemcitabine was determined.
Outcome measures
| Measure |
Neoadjuvant ABI-007, Carboplatin, and Gemcitabine
n=22 Participants
Neoadjuvant ABI-007 (260 mg/m\^2) on day 1, Carboplatin (Target AUC \[Area under the curve\] =5) on day 1, and Gemcitabine (800 mg\^m2) on days 1 and 8, every 21 days.
|
|---|---|
|
Percentage of Patients With Complete Pathologic Response After 3 Cycles of Treatment
|
27.3 percentage of patients
Interval 10.7 to 50.2
|
Adverse Events
Neoadjuvant ABI-007, Carboplatin, and Gemcitabine
Serious events: 26 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neoadjuvant ABI-007, Carboplatin, and Gemcitabine
n=29 participants at risk
Neoadjuvant ABI-007 (260 mg/m\^2) on day 1, Carboplatin (Target AUC \[Area under the curve\] =5) on day 1, and Gemcitabine (800 mg\^m2) on days 1 and 8, every 21 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.4%
1/29 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
75.9%
22/29 • Number of events 34
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
31.0%
9/29 • Number of events 9
|
|
Gastrointestinal disorders
Dehydration
|
3.4%
1/29 • Number of events 1
|
|
Nervous system disorders
Hemorrhage, CNS
|
3.4%
1/29 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.8%
4/29 • Number of events 4
|
|
Infections and infestations
Infection with Grade 3 or 4 neutrophils
|
3.4%
1/29 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
3.4%
1/29 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
3.4%
1/29 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
3.4%
1/29 • Number of events 1
|
|
General disorders
Flu-like syndrome
|
3.4%
1/29 • Number of events 1
|
Other adverse events
| Measure |
Neoadjuvant ABI-007, Carboplatin, and Gemcitabine
n=29 participants at risk
Neoadjuvant ABI-007 (260 mg/m\^2) on day 1, Carboplatin (Target AUC \[Area under the curve\] =5) on day 1, and Gemcitabine (800 mg\^m2) on days 1 and 8, every 21 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
65.5%
19/29 • Number of events 32
|
|
Blood and lymphatic system disorders
Leukopenia
|
65.5%
19/29 • Number of events 37
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.9%
2/29 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
86.2%
25/29 • Number of events 59
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
86.2%
25/29 • Number of events 46
|
|
Cardiac disorders
Hypertension
|
6.9%
2/29 • Number of events 2
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
86.2%
25/29 • Number of events 32
|
|
General disorders
Rigors/chills
|
6.9%
2/29 • Number of events 2
|
|
General disorders
Weight loss
|
6.9%
2/29 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
75.9%
22/29 • Number of events 25
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
17.2%
5/29 • Number of events 6
|
|
Vascular disorders
Hot flashes/flushes
|
10.3%
3/29 • Number of events 3
|
|
Gastrointestinal disorders
Anorexia
|
37.9%
11/29 • Number of events 11
|
|
Gastrointestinal disorders
Constipation
|
27.6%
8/29 • Number of events 9
|
|
Gastrointestinal disorders
Dehydration
|
10.3%
3/29 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
31.0%
9/29 • Number of events 9
|
|
Gastrointestinal disorders
Nausea
|
51.7%
15/29 • Number of events 18
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
10.3%
3/29 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
13.8%
4/29 • Number of events 5
|
|
Infections and infestations
Febrile neutropenia
|
13.8%
4/29 • Number of events 4
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
6.9%
2/29 • Number of events 2
|
|
General disorders
Edema: limb
|
6.9%
2/29 • Number of events 2
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
24.1%
7/29 • Number of events 8
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
20.7%
6/29 • Number of events 6
|
|
Metabolism and nutrition disorders
Creatinine
|
6.9%
2/29 • Number of events 2
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
31.0%
9/29 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
6.9%
2/29 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
17.2%
5/29 • Number of events 5
|
|
Nervous system disorders
Dizziness
|
10.3%
3/29 • Number of events 3
|
|
Nervous system disorders
Neuropathy: sensory
|
58.6%
17/29 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
13.8%
4/29 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Limb Pain
|
20.7%
6/29 • Number of events 6
|
|
Nervous system disorders
Headache Pain
|
10.3%
3/29 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
17.2%
5/29 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
24.1%
7/29 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Pelvic Pain
|
13.8%
4/29 • Number of events 6
|
|
General disorders
Pain - Other (Specify)
|
13.8%
4/29 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
13.8%
4/29 • Number of events 4
|
|
Renal and urinary disorders
Cystitis
|
10.3%
3/29 • Number of events 3
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
20.7%
6/29 • Number of events 6
|
Additional Information
Dr. David Smith, M.D.
University of Michigan Comprehensive Cancer Center
Phone: 734-936-6884
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place