This phase II trial studies how well paclitaxel albumin-stabilized nanoparticle formulation maintenance therapy works after cisplatin-based chemotherapy and surgery in treating patients with high-risk bladder cancer. Maintenance therapy, such as paclitaxel albumin-stabilized nanoparticle formulation, can help keep cancer from coming back after it has disappeared following initial chemotherapy.
PRIMARY OBJECTIVES: I. To evaluate the 6-month progression-free survival (PFS) rate in patients with high risk urothelial carcinoma treated with cisplatin-based neoadjuvant chemotherapy followed by curative intent cystectomy receiving maintenance therapy with paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel). SECONDARY OBJECTIVES: I. To evaluate overall survival (OS), time to progression and duration of response in patients treated with cisplatin-based neoadjuvant chemotherapy followed by curative intent cystectomy receiving maintenance therapy with nab-paclitaxel. II. To evaluate the adverse events associated with use of single agent nab-paclitaxel (Abraxane®) in patients with high risk urothelial carcinoma receiving maintenance therapy III. To evaluate Health Related Quality of life (HRQoL) as assessed by the European Organization for Research and Treatment of Care (EORTC) QLQ-C30. TERTIARY OBJECTIVES: I. To determine the presence of circulating tumor cells (CTC) in high risk patients with urothelial carcinoma prior to initiation of maintenance therapy (baseline) and after nab-paclitaxel exposure (at cycles 2, 4). OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Correlative studies
Ancillary studies
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Proportion of progression-free survivors assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the approach of Duffy and Santner. Additionally, if some patients are lost to follow-up not having been observed for at least 6 months, an estimate and confidence interval for the 6-month progression-free survival rate incorporating censoring will be computed using the method of Kaplan-Meier (1958).
Time frame: 6 months
Duration of response assessed by RECIST
The distribution of duration of response will be estimated using the method of Kaplan-Meier (1958).
Time frame: From the date at which the patient's earliest best objective status is first noted to be at least a partial response or better to the earliest date progression is documented
Frequency and severity of observed adverse effects assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Time frame: Up to 2 years
Overall survival (OS)
The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).
Time frame: From the date of registration to the event of death due to any cause, up to 2 years
Quality of life assessed using the EORTC QLQ-C30
28 of the 30 items are measured on a 1-4 scale (1=not at all; 4=very much) with the remaining two items (overall health and overall quality of life) scored on a 1-7 numeric analogue scale (1=very poor; 7=excellent). The recall period for the EORTC QLQ-C30 is one week.
Time frame: At baseline, before each chemotherapy cycle, at end of treatment and at 3 and 6 month observation visits
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Time to disease progression assessed by RECIST
The distribution of time to progression will be estimated using the method of Kaplan-Meier (1958).
Time frame: From the date of registration to the earliest date of documentation of disease progression, up to 2 years