Paclitaxel Albumin-Stabilized Nanoparticle Formulation After Cisplatin-Based Chemotherapy and Surgery in Treating Patients With High-Risk Bladder Cancer

NCT02718742 | Withdrawn Phase 2 DMC

• 3 other identifiers: MC1551NCI-2016-00133P30CA015083
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Bladder Urothelial Carcinoma; Stage IV Bladder Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months

Secondary Outcomes (5)

• Duration of response assessed by RECIST

  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)

  Up to 2 years

• Overall survival (OS)

  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

  At baseline, before each chemotherapy cycle, at end of treatment and at 3 and 6 month observation visits

• Time to disease progression assessed by RECIST

  From the date of registration to the earliest date of documentation of disease progression, up to 2 years

Study Arms (1)

Treatment (nab-paclitaxel)

EXPERIMENTAL

Patients receive paclitaxel albumin-stabilized nanoparticle formulation 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.

Other: Laboratory Biomarker Analysis; Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation; Other: Quality-of-Life Assessment

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (nab-paclitaxel)

Paclitaxel Albumin-Stabilized Nanoparticle Formulation DRUG

Given IV

Also known as: ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, nab-paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, protein-bound paclitaxel

Treatment (nab-paclitaxel)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (nab-paclitaxel)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of urothelial carcinoma and high risk residual disease after neoadjuvant chemotherapy (NAC) and cystectomy as defined by post-operative pathological pT4 or N1-3 disease, or progressive disease during NAC (NAC include methotrexate, vinblastin, doxorubicin and cisplatin \[MVAC\], dose dense MVAC, gemcitabine cisplatin, or gemcitabine carboplatin); minor histologic variants (\< 50%) are acceptable if urothelial carcinoma is predominant variant
• Post-operative computed tomography (CT) scan of the chest, abdomen, and pelvis =\< 30 days prior to registration demonstrating no evidence of residual or recurrent malignancy
• Life expectancy \>= 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Absolute neutrophil count (ANC) \>= 1500/mm\^3
• Platelet count \>= 100,000/mm\^3
• Hemoglobin \>= 9.0 g/dL
• Total bilirubin =\< 1.5 mg/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
• Alkaline phosphatase =\< 2.5 x upper limit of normal (ULN)
• Creatinine =\< 1.5 mg/dL or creatinine clearance \>= 40mL/mon (using Cockcroft-Gault formula)
• Females of child-bearing potential, defined as a sexually mature woman who (1) has not undergone hysterectomy or bilateral oophorectomy or (2) has not been naturally postmenopausal for at least 24 consecutive months must:
• Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting intraperitoneal (IP) therapy (including dose interruptions), and while on study medication or for a longer period if required by local regulations following the last dose of IP
• Negative serum pregnancy test done =\< 7 days prior to registration and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy; this applies even if the subject practices true abstinence from heterosexual contact
• Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during those interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy

You may not qualify if:

• Radiographic evidence measurable of residual or metastatic disease after surgery
• Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects to a developing fetus or nursing child:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
• Other active malignancy =\< 3 years prior to registration except for locally curable cancers that have been in apparently cured, such as basal or squamous cell skin cancer, prostate cancer without evidence of prostate-specific antigen (PSA) progression or carcinoma in situ such as the following: gastric, cervix, colon, melanoma or breast for example
• History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
• Pure small cell histologic variant or other pure non-urothelial carcinomas

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Interventions

Taxes; Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Estrella Carballido

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

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: February 10, 2016
• First Posted: March 24, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2021
• Last Updated: April 18, 2016

Record last verified: 2016-04

Locations

US (1)