Loading clinical trials...

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

WITHDRAWNPHASE2

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

Maintenance Nab-Paclitaxel After Cisplatin-Based Neoadjuvant Chemotherapy in Patients With High Risk Bladder Cancer

NCT02718742•Mayo Clinic

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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)
+9 more criteria

Exclusion Criteria

•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
+2 more criteria

Locations (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Key Dates

Start Date

June 1, 2016

Primary Completion Date

June 1, 2021

Last Updated

April 18, 2016

Conditions

Recurrent Bladder Urothelial CarcinomaStage IV Bladder Urothelial Carcinoma

Interventions

Laboratory Biomarker Analysis

OTHER

Paclitaxel Albumin-Stabilized Nanoparticle Formulation

DRUG

Quality-of-Life Assessment

OTHER

Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

NCT05987241

Muscle Invasive Bladder Urothelial CarcinomaMuscle Invasive Renal Pelvis Urothelial Carcinoma+5 more

View study

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction

NCT00365157

Advanced Urothelial CarcinomaLocally Advanced Urothelial Carcinoma+5 more

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Cancer of the Urothelium and Kidney Dysfunction

Acupuncture for the Treatment of Intravesical BCG-Related Adverse Events in High-Risk Non-muscle Invasive Bladder Cancer

Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemo

Ultrasound and Biomarker Tests in Predicting Cancer Aggressiveness in Tissue Samples of Patients With Bladder Cancer

Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors