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A Multi-Institutional Phase II Study of Single Agent Abraxane as Second Line Therapy in Patients With Advanced Transitional Cell Carcinoma of the Urothelium

Phase 2
18 Years
Open (Enrolling)
Transitional Cell Carcinoma

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Trial Information

A Multi-Institutional Phase II Study of Single Agent Abraxane as Second Line Therapy in Patients With Advanced Transitional Cell Carcinoma of the Urothelium

For those patients with advanced bladder cancer who have progressed on a platinum based
regimen, no widely accepted standard second line therapy currently exists. Taxanes
including paclitaxel have exhibited clinical activity in this disease and are sometimes
given off study. However, toxicities including neurotoxicity and hypersensitivity reactions
often limit the use of paclitaxel. ABRAXANE may allow delivery of a greater dose of
paclitaxel to those with bladder cancer with an easier method of administration and with
less toxicity.

Inclusion Criteria:

- Patients must have histological or cytological diagnosis of urothelial carcinoma.
Mixed histologies are permitted as long as transitional cell carcinoma is the major
component (i.e. >50% of the pathologic specimen). Pure or predominant squamous cell
carcinomas are not permitted.

- Patients with transitional cell carcinomas of the renal pelvis and ureter are

- Patients must have metastatic or locally advanced unresectable disease.

- Patients must have received one and only one prior chemotherapeutic regimen which
included a platinum (at least one cycle) for metastatic/recurrent disease.
Neoadjuvant or adjuvant chemotherapy will be considered to have been first line if
the patient progressed within 12 months of the last dose.

- Neoadjuvant/adjuvant chemotherapy (with or without a taxane) is permitted if
registration is greater than 12 months since the last dose (patients must then have
received one platinum containing regimen in the metastatic setting)

- ECOG performance status <= 2.

- Estimated life expectancy of >12 weeks.

- Patients must have measurable disease according to RECIST criteria.

- If female of childbearing potential, pregnancy test is negative within 72 hours
priors to first dose of study drug.

- If fertile, patient agrees to use an effective method of contraception to avoid
pregnancy for the duration of the study.

- Adequate organ function; Absolute neutrophil count >1.5 x 109/L. Platelet count >100
x109/L. Hemoglobin >90 g/L. Total bilirubin <1.5x upper limit of normal.
Transaminases <3x upper limit of normal (<5x if liver metastasis are present)
Calculated creatinine clearance >40 ml/min (Cockcroft & Gault formula)

- Able to give informed consent.

Exclusion Criteria:

- Prior taxane therapy for metastatic disease (or > 12 months since a taxane-containing
neoadjuvant or adjuvant chemotherapy).

- Pre-existing peripheral neuropathy >1 by NCI-CTC criteria.

- Pregnant or lactating females.

- Uncontrolled brain or leptomeningeal involvement (treated brain metastasis permitted
if both known lesions and medications e.g. steroids for that indication are stable).

- History of serious or concurrent illness that might be aggravated by study treatment.

- History of class II-IV congestive heart failure.

- Other malignancies except adequately controlled basal cell carcinoma of the skin or
carcinoma in situ of the cervix or incidental prostate cancer (T1a, Gleason <7 PSA
<10ng/ml) or any other tumor within 5 years prior to enrollment.

- Other investigational therapy or radiation therapy within 30 days before

- Patients not willing to employ adequate contraception for the duration of the study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Yoo-Joung Ko, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Health Sciences Centre


Canada: Health Canada

Study ID:




Start Date:

March 2008

Completion Date:

September 2011

Related Keywords:

  • Transitional Cell Carcinoma
  • Carcinoma
  • Carcinoma, Transitional Cell