Trial Outcomes & Findings for Intravesicular Abraxane for Treatment-Refractory Bladder Cancer (NCT NCT00583349)
NCT ID: NCT00583349
Last Updated: 2025-02-17
Results Overview
To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose (MTD). A DLT is defined by the National Cancer Institute Common Toxicity Criteria version 3.0
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
46 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-02-17
Participant Flow
Participant milestones
| Measure |
Abraxane 150 mg
Phase 1, dose level 1: Patients will receive intravesical 150 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 225 mg
Phase 1, dose level 2: Patients will receive intravesical 225 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 300 mg
Phase 1, dose level 3: Patients will receive intravesical 300 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 375 mg
Phase 1, dose level 4: Patients will receive intravesical 375 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 450 mg
Phase 1, dose level 5: Patients will receive intravesical 450 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 500 mg
Phase 1, dose level 6: Patients will receive intravesical 500 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
MTD: Abraxane 500 mg
Phase 2: Patients will receive the maximum tolerated dose (MTD) intravesical 500 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
|---|---|---|---|---|---|---|---|
|
Phase 1: Dose Level 1
STARTED
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Level 1
COMPLETED
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Level 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Level 2
STARTED
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Level 2
COMPLETED
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Level 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Level 3
STARTED
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Level 3
COMPLETED
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Level 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Level 4
STARTED
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Phase 1: Dose Level 4
COMPLETED
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Phase 1: Dose Level 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Level 5
STARTED
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Phase 1: Dose Level 5
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1: Dose Level 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Phase 1: Dose Level 6
STARTED
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Phase 1: Dose Level 6
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Phase 1: Dose Level 6
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2: Maximum Tolerated Dose
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
28
|
|
Phase 2: Maximum Tolerated Dose
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
28
|
|
Phase 2: Maximum Tolerated Dose
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravesicular Abraxane for Treatment-Refractory Bladder Cancer
Baseline characteristics by cohort
| Measure |
Abraxane 150 mg
n=3 Participants
Phase 1, dose level 1: Patients will receive intravesical 150 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 225 mg
n=3 Participants
Phase 1, dose level 2: Patients will receive intravesical 225 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 300 mg
n=3 Participants
Phase 1, dose level 3: Patients will receive intravesical 300 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 375 mg
n=3 Participants
Phase 1, dose level 4: Patients will receive intravesical 375 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 450 mg
n=3 Participants
Phase 1, dose level 5: Patients will receive intravesical 450 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 500 mg
n=3 Participants
Phase 1, dose level 6: Patients will receive intravesical 500 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
MTD: Abraxane 500 mg
n=28 Participants
Phase 2: Patients will receive the maximum tolerated dose (MTD) intravesical 500 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
≥ 18 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
46 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
35 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
3 participants
n=8 Participants
|
28 participants
n=8 Participants
|
46 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 6 weeksTo determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose (MTD). A DLT is defined by the National Cancer Institute Common Toxicity Criteria version 3.0
Outcome measures
| Measure |
Abraxane 150 mg
n=3 Participants
Phase 1, dose 1: Patients will receive intravesical 150 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 225 mg
n=3 Participants
Phase 1, dose 2: Patients will receive intravesical 225 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 300 mg
n=3 Participants
Phase 1, dose 3: Patients will receive intravesical 300 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 375 mg
n=3 Participants
Phase 1, dose 4: Patients will receive intravesical 375 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 450 mg
n=3 Participants
Phase 1, dose 5: Patients will receive intravesical 450 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 500 mg
n=3 Participants
Phase 1, dose 6: Patients will receive intravesical 500 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
MTD: Abraxane 500 mg
n=28 Participants
Phase 2: Patients will receive the maximum tolerated dose (MTD) intravesical 500 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Grade 1 local toxicity
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Grade 2 local toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Grade 3 or higher local toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksTo evaluate the utility (potential for clinical efficacy) of Abraxane in the treatment of refractory superficial transitional cell carcinomas (TCC) as measured by response rate (defined as negative cytology and bladder biopsy). Patients were considered to have a complete response if they had a negative biopsy and negative cytology. All patients with positive biopsies or cytology were classified as having no response.
Outcome measures
| Measure |
Abraxane 150 mg
n=3 Participants
Phase 1, dose 1: Patients will receive intravesical 150 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 225 mg
n=3 Participants
Phase 1, dose 2: Patients will receive intravesical 225 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 300 mg
n=3 Participants
Phase 1, dose 3: Patients will receive intravesical 300 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 375 mg
n=3 Participants
Phase 1, dose 4: Patients will receive intravesical 375 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 450 mg
n=3 Participants
Phase 1, dose 5: Patients will receive intravesical 450 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 500 mg
n=3 Participants
Phase 1, dose 6: Patients will receive intravesical 500 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
MTD: Abraxane 500 mg
n=28 Participants
Phase 2: Patients will receive the maximum tolerated dose (MTD) intravesical 500 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Complete Response (CR) or No Response (NR) After Treatment
CR
|
1 participants
|
3 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
10 participants
|
|
Number of Participants With Complete Response (CR) or No Response (NR) After Treatment
NR
|
2 participants
|
0 participants
|
3 participants
|
2 participants
|
3 participants
|
3 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data were not collected.
Outcome measures
Outcome data not reported
Adverse Events
Abraxane 150 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Abraxane 225 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Abraxane 300 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Abraxane 375 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Abraxane 450 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Abraxane 500 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MTD: Abraxane 500 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Abraxane 150 mg
n=3 participants at risk
Patients will receive intravesical 150 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 225 mg
n=3 participants at risk
Patients will receive intravesical 150 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 300 mg
n=3 participants at risk
Patients will receive intravesical 300 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 375 mg
n=3 participants at risk
Patients will receive intravesical 375 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 450 mg
n=3 participants at risk
Patients will receive intravesical 450 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
Abraxane 500 mg
n=3 participants at risk
Patients will receive intravesical 500 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
MTD: Abraxane 500 mg
n=28 participants at risk
Phase 2: Patients will receive the maximum tolerated dose (MTD) intravesical 500 mg Abraxane by sterile urethral catheterization once weekly for six weeks.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Systemic Absorption of Drug
|
0.00%
0/3 • 24 months
|
0.00%
0/3 • 24 months
|
0.00%
0/3 • 24 months
|
0.00%
0/3 • 24 months
|
33.3%
1/3 • 24 months
|
0.00%
0/3 • 24 months
|
0.00%
0/28 • 24 months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • 24 months
|
33.3%
1/3 • 24 months
|
33.3%
1/3 • 24 months
|
33.3%
1/3 • 24 months
|
0.00%
0/3 • 24 months
|
66.7%
2/3 • 24 months
|
0.00%
0/28 • 24 months
|
|
Renal and urinary disorders
Urinary Retention
|
33.3%
1/3 • 24 months
|
0.00%
0/3 • 24 months
|
0.00%
0/3 • 24 months
|
33.3%
1/3 • 24 months
|
0.00%
0/3 • 24 months
|
33.3%
1/3 • 24 months
|
0.00%
0/28 • 24 months
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/3 • 24 months
|
33.3%
1/3 • 24 months
|
0.00%
0/3 • 24 months
|
0.00%
0/3 • 24 months
|
0.00%
0/3 • 24 months
|
33.3%
1/3 • 24 months
|
0.00%
0/28 • 24 months
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • 24 months
|
0.00%
0/3 • 24 months
|
0.00%
0/3 • 24 months
|
33.3%
1/3 • 24 months
|
0.00%
0/3 • 24 months
|
33.3%
1/3 • 24 months
|
3.6%
1/28 • 24 months
|
Additional Information
Dr. James McKiernan, John K. Lattimer Professor and Chair of Department of Urology
Columiba University Medical Center
Phone: 212-342-3976
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place