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A Phase Two Trial of Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Patients With Locally Advanced Carcinoma of the Bladder


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

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Trial Information

A Phase Two Trial of Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Patients With Locally Advanced Carcinoma of the Bladder


Inclusion Criteria:



- Histologically proven locally advanced (T2-4,N0,M0 or Tany,N1-3,M0) urothelial
carcinoma of the bladder and be candidates for cystectomy following chemotherapy.
Tumor specimens must be available for assay of molecular markers (correlative
research).

- Performance status of 0, 1 or 2 by Eastern Cooperative Oncology Group (ECOG)
criteria.

- Serum creatinine <2.0 mg/dl and/or creatinine clearance >40 ml/min.

- Granulocyte count > 1,500/mm3, platelet > 100,000/mm3, and hemoglobin > 9.0 g/dl.

- Adequate liver functions: AST and ALT < 2.5 X upper limit of normal, alkaline
phosphatase < 2.5 X upper limit of normal, and bilirubin < 1.5 mg/dl.

- Pre-existing peripheral neuropathy > grade 2

- Recovered from any effects of surgery.

- Women/men of reproductive potential may not participate unless they have agreed to
use an effective contraceptive method. Women with reproductive potential must have a
negative pregnancy test.

Exclusion Criteria:

- Prior systemic or intra-arterial chemotherapy and rior radiotherapy. (intravesical
chemotherapy allowed.)

- Pre-existing peripheral neuropathy > grade 2

- Prior malignancy [except for adequately treated basal cell (or squamous cell) skin
cancer, in situ cervical cancer or other cancer for which the patient has been
disease free for 2 years]

- Unresolved bacterial infection requiring active treatment with antibiotics.
(Treatment may begin at the conclusion of antibiotic therapy.)

- Pregnant or lactating women may not participate.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Estimate the rate of pathologic complete response following three cycles of neoadjuvant ABI-007, carboplatin and gemcitabine in patients with invasive urothelial carcinoma.

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

David C Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2007.061

NCT ID:

NCT00585689

Start Date:

December 2007

Completion Date:

April 2013

Related Keywords:

  • Bladder Cancer
  • Locally advanced urothelial carcinoma of the bladder
  • Urinary Bladder Neoplasms

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624