ABC123 Framework for Advanced Bladder Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Elizabeth R. Kessler

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

Disqualifiers: Advanced cancer, Systemic therapy, others

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. ^{1 2 3 4 5}

Research Team

Elizabeth R. Kessler

Principal Investigator

University of Colorado, Denver

Eligibility 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

Provision to sign and date the consent form

My cancer cannot be cured with surgery or radiation and may need chemotherapy.

I am over 65, or over 60 with a health issue found in a senior's health check.

Exclusion Criteria

I have been treated with medication for another advanced cancer.

Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Care Planning

Implementation of the ABC123 framework with initial care planning, including a short physical performance battery and chemotherapy toxicity estimation

1 month

2 visits (in-person)

Follow-up

Participants complete surveys and interviews at 1, 3, and 6 months to evaluate the framework's impact and gather feedback

6 months

3 visits (in-person)

Long-term Stakeholder Feedback

Interviews with care providers and stakeholders at 1, 2, and 3 years to assess feasibility and experiences with the ABC123 framework

3 years

Treatment Details

Interventions

• ABC123 Framework (Behavioral)

Trial Overview 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.

Participant Groups

Group I: Older patients with advanced cancer Experimental Treatment 1 Intervention

Patients over 60 years old with advanced, incurable cancer.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Dr. Larry Weiss

American Cancer Society, Inc.

Chief Medical Officer since 2016

MD from Duke University Medical Center

Dr. Wayne A. I. Frederick

American Cancer Society, Inc.

Chief Executive Officer

MD from Howard University, MBA from Howard University

Findings from Research

Cisplatin and gemcitabine are the most commonly used first-line treatment for advanced bladder cancer, showing comparable efficacy and better tolerance than the traditional four-drug regimen, especially for patients who cannot receive cisplatin due to comorbidities.

Recent advancements in molecular characterization of advanced bladder cancer have revealed actionable genetic alterations, leading to the development of targeted therapies that may significantly improve treatment outcomes by matching specific mutations with appropriate treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of genomics in the management of advanced bladder cancer. Guancial, EA., Rosenberg, JE.[2018]

Recent advances in genomic characterization and new therapeutic options have revitalized the treatment landscape for advanced-stage bladder cancer, which has seen little progress over the past 30 years.

The review discusses multimodal treatment strategies, including chemotherapy and innovative immunomodulatory and targeted therapies, aimed at improving outcomes for patients with locally advanced and metastatic urothelial carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Muscle-Invasive Urothelial Cancer and the Emerging Role of Immunotherapy in Advanced Urothelial Cancer. Giridhar, KV., Kohli, M.[2018]

In a study of 508 patients with stage IV bladder cancer, platinum-based chemotherapy was the most common treatment, with a median overall survival of 9.4 months from diagnosis, indicating its effectiveness in this population.

Patients who did not receive any treatment had a significantly higher risk of death (hazard ratio of 2.06), highlighting the importance of treatment in improving survival outcomes for advanced bladder cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Patterns and Outcomes in Stage IV Bladder Cancer in a Community Oncology Setting: 2008-2015. Fisher, MD., Shenolikar, R., Miller, PJ., et al.[2019]

Over a 20-year period, the use of neoadjuvant chemotherapy (NAC) for patients with cT2+ bladder cancer significantly increased, peaking at 84.2% in the last year of the study, with 100% usage in eligible patients.

Patients receiving NAC showed improved survival rates, with 5-year overall survival increasing from 42.7% in the pre-NAC era to 53.2% in the NAC era, indicating that NAC is associated with better outcomes for bladder cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of treatment pathway improves neoadjuvant chemotherapy use in muscle-invasive bladder cancer. Faraj, KS., Navaratnam, AK., Eversman, S., et al.[2021]

Chemotherapy significantly improves cancer-specific mortality-free survival in patients with metastatic micropapillary carcinoma of the urinary bladder (MCUB), with a hazard ratio of 0.36, indicating a strong protective effect.

In contrast, chemotherapy showed no benefit for patients with organ-confined MCUB, and while there may be a potential protective effect in non-organ-confined stages, the study lacked sufficient statistical power to confirm this.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Micropapillary Versus Urothelial Carcinoma of the Urinary Bladder: Stage at Presentation and Efficacy of Chemotherapy Across All Stages-A SEER-based Study. Deuker, M., Stolzenbach, LF., Collà Ruvolo, C., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The role of genomics in the management of advanced bladder cancer. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Management of Muscle-Invasive Urothelial Cancer and the Emerging Role of Immunotherapy in Advanced Urothelial Cancer. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment Patterns and Outcomes in Stage IV Bladder Cancer in a Community Oncology Setting: 2008-2015. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Use of treatment pathway improves neoadjuvant chemotherapy use in muscle-invasive bladder cancer. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Micropapillary Versus Urothelial Carcinoma of the Urinary Bladder: Stage at Presentation and Efficacy of Chemotherapy Across All Stages-A SEER-based Study. [2022]