ABC123 Framework for Advanced Bladder Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Colorado, Denver
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a new care planning framework called ABC123 for older patients with advanced cancer. It combines tools from elderly care, cancer treatment, and comfort care to create personalized plans. The goal is to ensure that the care aligns with what patients want and need.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
How is the ABC123 treatment for advanced bladder cancer different from other treatments?
The ABC123 treatment is unique because it focuses on targeting specific genetic mutations in bladder cancer, using a personalized approach based on the tumor's genetic profile, rather than the traditional 'one-size-fits-all' chemotherapy. This approach aims to match the treatment to the patient's specific cancer characteristics, potentially leading to more effective outcomes.
12345Eligibility Criteria
This trial is for people over 60 with advanced, incurable cancer who are seeing an oncologist for the first time. They must be able to sign a consent form, follow study procedures for 6 months, and speak English. It's not open to those who've had systemic therapy for another advanced cancer or have conditions that could interfere with the study.Inclusion Criteria
I am over 65, or over 60 with a health issue found in a senior's health check.
I speak English.
Exclusion Criteria
I have been treated with medication for another advanced cancer.
Participant Groups
The ABC123 framework is being tested in this pilot study. It integrates geriatric, oncology, and palliative medicine into care planning by an advanced practice provider alongside a medical oncologist. The goal is to see if it's feasible and matches patient-clinician goals.
1Treatment groups
Experimental Treatment
Group I: Older patients with advanced cancerExperimental Treatment1 Intervention
Patients over 60 years old with advanced, incurable cancer.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of Colorado Cancer CenterAurora, CO
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
American Cancer Society, Inc.Collaborator
References
The role of genomics in the management of advanced bladder cancer. [2018]Advanced bladder cancer (ABC) is an aggressive malignancy with a poor prognosis. For the last 30 years, the standard of care for this disease has consisted of combination chemotherapy with a platinum-containing regimen as first-line therapy. Cisplatin is the most active cytotoxic agent against bladder cancer, but because of competing comorbidities, many patients are ineligible for this agent and instead receive carboplatin. The two-drug regimen of cisplatin and gemcitabine was found to be better tolerated and have comparable efficacy as the four-drug regimen of methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) in a randomized study of patients with advanced disease. Therefore, cisplatin (or carboplatin) and gemcitabine is the most commonly used first-line regimen in this setting. No agents have been approved by the Food and Drug Administration (FDA) for second-line therapy in ABC. If patients are eligible for additional systemic treatment at the time of progression, options include single-agent therapy such as a taxane or pemetrexed, though given the lack of standard approaches participation in a clinical trial should be strongly encouraged. Recent molecular characterization of ABC reveals significant genetic heterogeneity and actionable genomic alterations in the majority of tumors. Emerging therapies may effectively target known molecular drivers of ABC, including the FGFR2, EGFR/HER2, VEGF, MET, and PI3/AKT/mTOR pathways. Reports of dramatic and prolonged responses to targeted therapy provide additional support for the use of genome sequencing in the rationale selection of treatment for subsets of patients. The current focus of clinical trial development is to design molecularly driven studies that "match" tumors with driver mutations and appropriate targeted therapies rather than a "one-size-fits-all" approach based on clinical and pathologic parameters of disease. The hope of patients and clinicians alike is that this therapeutic approach combined with novel agents may usher in a new era of effective treatments for patients with ABC.
Management of Muscle-Invasive Urothelial Cancer and the Emerging Role of Immunotherapy in Advanced Urothelial Cancer. [2018]The incidence of bladder cancer has increased in the past decade, and mortality from bladder cancer remains a substantial public health burden. After 3 decades of minimal progress in the treatment of advanced-stage disease, recent advances in the genomic characterization of urothelial cancer and breakthroughs in bladder cancer therapeutics have rejuvenated the field. This review highlights the landmark clinical trials of chemotherapy in both the neoadjuvant and advanced or metastatic urothelial carcinoma settings. We describe treatment paradigms for multimodal treatment of locally advanced bladder cancer, including discussion on bladder preservation strategies. Lastly, we discuss novel immunomodulatory, targeted, and combination therapies in development for the treatment of advanced urothelial carcinoma.
Treatment Patterns and Outcomes in Stage IV Bladder Cancer in a Community Oncology Setting: 2008-2015. [2019]Current real-world data regarding treatment patterns in advanced bladder cancer in the community setting are limited. This study describes patient characteristics, treatment patterns, and effectiveness outcomes for stage IV bladder cancer in the community setting.
Use of treatment pathway improves neoadjuvant chemotherapy use in muscle-invasive bladder cancer. [2021]To assess the trends of neoadjuvant chemotherapy (NAC) use since its introduction in our practice pathway in patients with cT2 + bladder cancer over a 20-year period.
Micropapillary Versus Urothelial Carcinoma of the Urinary Bladder: Stage at Presentation and Efficacy of Chemotherapy Across All Stages-A SEER-based Study. [2022]Stage-specific guideline recommendations are lacking for chemotherapy in micropapillary carcinoma of the urinary bladder (MCUB).