Trial · NCT00583349
Intravesicular Abraxane for Treatment-Refractory Bladder Cancer
NCT00583349, Phase 1, Phase 2, Completed, Columbia University; results first posted 2025-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intravesicular Abraxane for Treatment-Refractory Bladder Cancer. Trials, record NCT00583349. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00583349
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intravesicular Abraxane for Treatment-Refractory Bladder Cancer
- NCT number
- NCT00583349
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Bladder Cancer
- Interventions
- Abraxane
- First posted
- 2007-12-31
- Last updated
- 2025-02-17
- Results first posted
- 2025-02-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | 6 weeks | 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 |
| Primary | Number of Participants With Complete Response (CR) or No Response (NR) After Treatment | 6 weeks | To 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. |
| Secondary | To Further Evaluate the Safety and Toxicity Profile of Intravesically Administered Abraxane Therapy. | 6 months |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | 6 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Complete Response (CR) or No Response (NR) After Treatment | 6 weeks | participants | NUMBER | |
| SECONDARY | To Further Evaluate the Safety and Toxicity Profile of Intravesically Administered Abraxane Therapy. | 6 months | Data were not collected. |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Abraxane 150 mg | Grade 1 local toxicity | 2 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Abraxane 225 mg | Grade 1 local toxicity | 2 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Abraxane 300 mg | Grade 1 local toxicity | 1 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Abraxane 375 mg | Grade 1 local toxicity | 3 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Abraxane 450 mg | Grade 1 local toxicity | 0 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Abraxane 500 mg | Grade 1 local toxicity | 3 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | MTD: Abraxane 500 mg | Grade 1 local toxicity | 4 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Abraxane 150 mg | Grade 2 local toxicity | 0 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Abraxane 225 mg | Grade 2 local toxicity | 0 | Participants | |
| Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Abraxane 300 mg | Grade 2 local toxicity | 0 | Participants |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow147
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1: Dose Level 1 | STARTED | Abraxane 150 mg | 3 | |
| Phase 1: Dose Level 1 | STARTED | Abraxane 225 mg | 0 | |
| Phase 1: Dose Level 1 | STARTED | Abraxane 300 mg | 0 | |
| Phase 1: Dose Level 1 | STARTED | Abraxane 375 mg | 0 | |
| Phase 1: Dose Level 1 | STARTED | Abraxane 450 mg | 0 | |
| Phase 1: Dose Level 1 | STARTED | Abraxane 500 mg | 0 | |
| Phase 1: Dose Level 1 | STARTED | MTD: Abraxane 500 mg | 0 | |
| Phase 1: Dose Level 1 | COMPLETED | Abraxane 150 mg | 3 | |
| Phase 1: Dose Level 1 | COMPLETED | Abraxane 225 mg | 0 | |
| Phase 1: Dose Level 1 | COMPLETED | Abraxane 300 mg | 0 |
1 to 10 of 147Source ClinicalTrials.gov
See all 147 participant flowAdverse events35
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Systemic Absorption of Drug | Blood and lymphatic system disorders | Abraxane 150 mg | 0 | 3 | |
| other | Systemic Absorption of Drug | Blood and lymphatic system disorders | Abraxane 225 mg | 0 | 3 | |
| other | Systemic Absorption of Drug | Blood and lymphatic system disorders | Abraxane 300 mg | 0 | 3 | |
| other | Systemic Absorption of Drug | Blood and lymphatic system disorders | Abraxane 375 mg | 0 | 3 | |
| other | Systemic Absorption of Drug | Blood and lymphatic system disorders | Abraxane 450 mg | 1 | 3 | |
| other | Systemic Absorption of Drug | Blood and lymphatic system disorders | Abraxane 500 mg | 0 | 3 | |
| other | Systemic Absorption of Drug | Blood and lymphatic system disorders | MTD: Abraxane 500 mg | 0 | 28 | |
| other | Dysuria | Renal and urinary disorders | Abraxane 150 mg | 0 | 3 | |
| other | Dysuria | Renal and urinary disorders | Abraxane 225 mg | 1 | 3 | |
| other | Dysuria | Renal and urinary disorders | Abraxane 300 mg | 1 | 3 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abraxane 150 mg | 0 | 3 |
| Total, all-cause mortality | Abraxane 225 mg | 0 | 3 |
| Total, all-cause mortality | Abraxane 300 mg | 0 | 3 |
| Total, all-cause mortality | Abraxane 375 mg | 0 | 3 |
| Total, all-cause mortality | Abraxane 450 mg | 0 | 3 |
| Total, all-cause mortality | Abraxane 500 mg | 0 | 3 |
| Total, all-cause mortality | MTD: Abraxane 500 mg | 2 | 28 |
| Total, other adverse events | Abraxane 150 mg | 2 | 3 |
| Total, other adverse events | Abraxane 225 mg | 2 | 3 |
| Total, other adverse events | Abraxane 300 mg | 1 | 3 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00583349
GET https://conductscience.org/api/trials/v1/NCT00583349/results?page=2