Single Agent Abraxane as Second Line Therapy in Bladder Cancer
A Multi-Institutional Phase II Study of Single Agent Abraxane as Second Line Therapy in Patients With Advanced Transitional Cell Carcinoma of the Urothelium
1 other identifier
interventional
48
1 country
5
Brief Summary
The purpose of this study is to determine what effects the drug Abraxane has on bladder cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2008
Typical duration for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 21, 2008
CompletedFirst Posted
Study publicly available on registry
May 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedOctober 17, 2016
October 1, 2016
4.3 years
May 21, 2008
October 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Response rate
one year
Secondary Outcomes (2)
safety
1 year
overall survival
1-2 years
Study Arms (1)
Nab-paclitaxel
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunnybrook Health Sciences Centrelead
- Celgene Corporationcollaborator
Study Sites (5)
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Related Publications (1)
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.
PMID: 23706985DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yoo-Joung Ko, MD
Sunnybrook Health Sciences Centre
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2008
First Posted
May 23, 2008
Study Start
March 1, 2008
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
October 17, 2016
Record last verified: 2016-10