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Single Agent Abraxane as Second Line Therapy in Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00683059
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE May 21, 2008
First Posted Date  ICMJE May 23, 2008
Last Update Posted Date October 17, 2016
Study Start Date  ICMJE March 2008
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2008)
Response rate [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2008)
  • safety [ Time Frame: 1 year ]
  • overall survival [ Time Frame: 1-2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Agent Abraxane as Second Line Therapy in Bladder Cancer
Official Title  ICMJE A Multi-Institutional Phase II Study of Single Agent Abraxane as Second Line Therapy in Patients With Advanced Transitional Cell Carcinoma of the Urothelium
Brief Summary The purpose of this study is to determine what effects the drug Abraxane has on bladder cancer.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Transitional Cell Carcinoma
Intervention  ICMJE Drug: Paclitaxel
total dose (mg) = body surface area in m2 x study dose (mg/m2) to be injected into a vein once every 3 weeks over 18 months.
Other Name: Abraxane
Study Arms  ICMJE Experimental: Nab-paclitaxel
Intervention: Drug: Paclitaxel
Publications * Ko YJ, Canil CM, Mukherjee SD, Winquist E, Elser C, Eisen A, Reaume MN, Zhang L, Sridhar SS. Nanoparticle albumin-bound paclitaxel for second-line treatment of metastatic urothelial carcinoma: a single group, multicentre, phase 2 study. Lancet Oncol. 2013 Jul;14(8):769-76. doi: 10.1016/S1470-2045(13)70162-1. Epub 2013 May 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2008)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 permitted.
  • 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 registration.
  • Patients not willing to employ adequate contraception for the duration of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00683059
Other Study ID Numbers  ICMJE ABX207-GU07CA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE
Principal Investigator: Yoo-Joung Ko, MD Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP