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A Combined Phase I & II Trial of Intravesicular Abraxane, a Nanoparticle Albumin-bound Paclitaxel, for Treatment-refractory Transitional Cell Carcinoma of the Urinary Bladder

Phase 1/Phase 2
18 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

A Combined Phase I & II Trial of Intravesicular Abraxane, a Nanoparticle Albumin-bound Paclitaxel, for Treatment-refractory Transitional Cell Carcinoma of the Urinary Bladder

Inclusion Criteria:

- Patients must have a diagnosis of transitional cell carcinoma (TCC) of the urinary
bladder confirmed at the study institution. The patient must have demonstrated
superficial recurrent bladder cancer refractory to standard intravesical therapy.
This will include stage Ta, T1, Tis and exclude all patients with muscle invasion
(T2). All patients with stage Ta will require documentation of high-grade histology.
All grossly visible disease must be fully resected and pathologic stage will be
confirmed at the institution where the patient is enrolled. Patients must exhibit
disease recurrence after receiving some form of standard intravesical therapy,
including BCG, mitomycin, interferon or any combination thereof.

- Age > 18 and must be able to read, understand and sign informed consent

- Performance Status: ECOG 0,1 (See Appendix II )

- Peripheral neuropathy: must be < grade 1

- Hematologic-Inclusion within 2 weeks of start of treatment

- Absolute neutrophil count > 1,500/mm3

- Hemoglobin >9.0 g/dl

- Platelet count > 100,000/mm3

- Hepatic-Inclusion within 2 weeks of entry

- Total Bilirubin must be within normal limits.

- Adequate renal function with serum creatinine ≤ 2.0 mg/dL

- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN for the
institution, Alkaline phosphatase ≤ 2.5 x ULN for the institution, unless bone
metastasis is present in the absence of liver metastasis

- Women of childbearing potential must have a negative pregnancy test.

- All patients of childbearing potential must be willing to consent to using effective
contraception, i.e., IUD, Birth control pills, Depo-Provera, and condoms while on
treatment and for 3 months after their participation in the study ends.

- No intravesical therapy within 6 weeks of study entry

- No prior radiation to the pelvis

Exclusion Criteria:

- Prior systemic docetaxel or paclitaxel therapy.

- Any other malignancy diagnosed within 2 years of study entry (except basal or
squamous cell skin cancers or non-invasive cancer of the cervix) is excluded.

- Concurrent treatment with any chemotherapeutic agent.

- Women who are pregnant or lactating.

- History of vesicoureteral reflux or an indwelling urinary stent.

- Participation in any other research protocol involving administration of an
investigational agent within 3 months prior to study entry aside from the phase I
segment of this study.

- History of neuropathy of any cause

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6 weeks, 4 months, 6 months

Safety Issue:


Principal Investigator

James M McKiernan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University Medical Center, Urology


United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Bladder Cancer
  • Chemotherapy
  • Bladder Neoplasms
  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell



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