Transitional Cell Carcinoma Clinical Trial
Official title:
A Multi-Institutional Phase II Study of Single Agent Abraxane as Second Line Therapy in Patients With Advanced Transitional Cell Carcinoma of the Urothelium
Verified date | October 2016 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
The purpose of this study is to determine what effects the drug Abraxane has on bladder cancer.
Status | Completed |
Enrollment | 48 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Juravinski Cancer Centre | Hamilton | Ontario |
Canada | London Regional Cancer Program | London | Ontario |
Canada | Ottawa Regional Cancer Centre | Ottawa | Ontario |
Canada | Princess Margaret Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | Celgene Corporation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | one year | No | |
Secondary | safety | 1 year | Yes | |
Secondary | overall survival | 1-2 years | No |
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