Single Agent Abraxane as Second Line Therapy in Bladder Cancer

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine what effects the drug Abraxane has on bladder cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Collaborator: Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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.