MedTrace Logo

Intravesicular Abraxane for Treatment-Refractory Bladder Cancer

NCT00583349 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-02-17

Study results available
· View outcomes & findings →

Summary

Phase I:

To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose.

To assemble tissue bank to assess molecular correlates for response to intravesical Abraxane therapy. The antibodies analyzed will include p53, p63, Stathmin, Tau and Ki67.

Phase II:

To evaluate the utility (potential for clinical efficacy) of Abraxane in the treatment of refractory non-muscle invasive and a subset of T2 TCC of the bladder as measured by response rate (defined as negative cytology and bladder biopsy).

To further evaluate the safety and toxicity profile of intravesically administered Abraxane therapy.

Conditions

Interventions

DRUG

Abraxane

Abraxane is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Intravesically administered, dose escalation, 6 weekly instillations

Sponsors & Collaborators

Principal Investigators

  • James M McKiernan, MD · Columbia University Irving Medical Center, Urology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2013-03-31
Completion
2014-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00583349 on ClinicalTrials.gov