Single Agent Abraxane as Second Line Therapy in Bladder Cancer

• Sponsor: Sunnybrook Health Sciences Centre (Other)
• Overall Status: Completed
• CT.gov ID: NCT00683059
• Collaborator: Celgene Corporation (Industry)
• Enrollment: 48
• Locations: 5
• Arm: 1
• Duration (Months): 51
• Patients Per Site: 9.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Transitional Cell Carcinoma	Drug: Paclitaxel	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nab-paclitaxel	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 Names: Abraxane

Outcome Measures

Primary Outcome Measures

1. Response rate [one year]

Secondary Outcome Measures

1. safety [1 year]

2. overall survival [1-2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
2	London Regional Cancer Program	London	Ontario	Canada	N6A 4L6
3	Ottawa Regional Cancer Centre	Ottawa	Ontario	Canada	K1H 8L6
4	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
5	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

• Sunnybrook Health Sciences Centre
• Celgene Corporation

Investigators

• Principal Investigator: Yoo-Joung Ko, MD, Sunnybrook Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunnybrook Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT00683059
• Other Study ID Numbers: ABX207-GU07CA
• First Posted: May 23, 2008
• Last Update Posted: Oct 17, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Transitional Cell; Paclitaxel

Study Results

No Results Posted as of Oct 17, 2016