Eribulin + Chemotherapy for Bladder Cancer
Recruiting in Palo Alto (17 mi)
+295 other locations
Overseen BySarmad Sadeghi
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: National Cancer Institute (NCI)
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This phase III trial compares the usual chemotherapy treatment to eribulin plus gemcitabine in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as eribulin, gemcitabine, docetaxel, paclitaxel, and sacituzumab govitecan work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial aims to see whether adding eribulin to standard of care chemotherapy may work better in treating patients with metastatic urothelial cancer.
What data supports the effectiveness of the drug combination Eribulin and chemotherapy for bladder cancer?
Research shows that combinations of drugs like docetaxel and gemcitabine have been used effectively in treating advanced bladder cancer, with promising results in terms of response rates. These drugs are part of the combination being studied, suggesting potential effectiveness for the new treatment.
124711Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, if you are taking strong or moderate CYP3A or CYP2C8 inhibitors or inducers, you may need to stop them at least 2 weeks before starting the trial if you are assigned to certain treatment groups.
What makes the Eribulin + Chemotherapy treatment unique for bladder cancer?
This treatment is unique because it combines eribulin, a drug not commonly used for bladder cancer, with other chemotherapy agents like gemcitabine and docetaxel, offering an option for patients who cannot use standard cisplatin-based treatments.
346911Is the combination of Eribulin and chemotherapy safe for treating bladder cancer?
Studies have shown that the combination of gemcitabine and docetaxel, which are part of the chemotherapy regimen, has been evaluated for safety in treating advanced bladder cancer. These studies generally focus on the side effects and how well patients tolerate the treatment, indicating that while there are side effects, the treatment is considered manageable for many patients.
5781011Eligibility Criteria
This trial is for adults with metastatic urothelial cancer who've had platinum-based and PD1/PDL1 antibody therapy, possibly enfortumab vedotin. They should have good organ function, no immediate CNS treatment needs, not be pregnant or breastfeeding, and willing to use contraception. Excluded are those with recent gemcitabine progression or unresolved toxicities from past treatments.Inclusion Criteria
I have received a PD1/PDL1 antibody treatment for my metastatic cancer.
My cancer, found in a distant part of my body, is mainly urothelial carcinoma.
I am on HIV treatment and my recent tests show no detectable virus.
My hepatitis B virus load is undetectable as of the last month.
I have finished all my scheduled surgeries or radiation treatments.
I don't have major side effects from past surgeries or radiation.
I am 18 years old or older.
I can take care of myself and am up and about more than 50% of my waking hours.
I have received enfortumab vedotin as part of my previous treatment for metastatic cancer.
My kidney function is good, with a creatinine clearance rate of at least 20 mL/min.
My liver tests are within the required range.
Participant Groups
The study compares standard chemotherapy alone versus adding the drug Eribulin either alone or with Gemcitabine in treating metastatic urothelial cancer. It aims to find out if Eribulin can improve outcomes when combined with usual chemotherapy drugs.
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm III (eribulin, gemcitabine)Experimental Treatment6 Interventions
Patients receive eribulin IV over 2-5 minutes and gemcitabine IV on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI throughout the trial and may undergo bone scan at the discretion of the treating physician. Patients also undergo blood and urine sample collection on the trial.
Group II: Arm II (eribulin)Experimental Treatment5 Interventions
Patients receive eribulin IV over 2-5 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI throughout the trial and may undergo bone scan at the discretion of the treating physician. Patients also undergo blood and urine sample collection on the trial. (CLOSED TO ACCRUAL)
Group III: Arm I (standard of care chemotherapy)Active Control8 Interventions
See Detailed Description.
Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
🇪🇺 Approved in European Union as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
🇨🇦 Approved in Canada as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
🇯🇵 Approved in Japan as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Spectrum Health at Butterworth CampusGrand Rapids, MI
Huntsman Cancer Institute/University of UtahSalt Lake City, UT
Bozeman Health Deaconess HospitalBozeman, MT
Regional Cancer Center at Indian Path Community HospitalKingsport, TN
More Trial Locations
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Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
References
[The role of new drugs in the treatment of locally advanced urothelial tumors of the bladder]. [2022]Although the optimal management of muscle-invasive bladder cancer remains a continued subset of controversy, results achieved with either radical cystectomy, or radiation therapy or combinations of the two lead to cure rates of only 50% with up to 50% of patients who will develop metastases, usually within two years. For the past ten years, chemotherapy of advanced urothelial tumors has focused on cisplatin-based combinations such as methotrexate-vinblastine-adriamycin-cisplatin (M-VAC), cisplatin-methotrexate-vinblastine (CMV) or cisplatin-adriamycin-cyclophosphamide (CISCA). Such regimens have provided interesting results with responses rate up to 70% and some long term survival (in 10 to 20% of patients), but this has focused achieved with moderate to severe toxicity. Thus, if the chemosensitivity of advanced urothelial tumors is obvious, it is clear that a therapeutic plateau has been reached and only the search for new active agents can provide any hope to improve the results of these established regimens. Recently some single agents under investigation including taxanes (paclitaxel and docétaxel) and gemcitabine have been identified and have entered clinical development. Preliminary data of several phase II studies are now available and they appear promising, providing the basis of new combinations regimens that will attempt to improve results that have been achieved with standard regimens during the past decade. The activity of these new single agents and new combination are reviewed.
Docetaxel and ifosfamide as second line treatment for patients with advanced or metastatic urothelial cancer after failure of platinum chemotherapy: a phase 2 study. [2019]This phase 2 trial was designed to assess the efficacy and safety of combination chemotherapy with docetaxel and ifosfamide in previously treated patients with advanced urothelial cancer.
Gemcitabine in the treatment of bladder cancer. [2022]New agents are available for the treatment of metastatic transitional cell carcinoma of the bladder. In the US, the combination of methotrexate, vinblastine, doxorubicin and cisplatin (M-VAC) remains the standard chemotherapy regimen for advanced bladder cancer. Gemcitabine (2',2'-difluorodeoxycytidine [dFdC]) is a relatively new agent with a favourable toxicity profile that has demonstrated activity against a number of solid tumours in both preclinical and clinical studies. Single-agent gemcitabine has shown activity in bladder cancer in both pretreated and chemotherapy-naïve patients. The combination of gemcitabine plus cisplatin is a regimen with significant activity and moderate toxicity in bladder cancer patients. A randomised trial of gemcitabine plus cisplatin versus M-VAC has completed accrual but has not yet been reported. New combination studies of gemcitabine with other chemotherapy agents, including the taxanes, are ongoing.
Weekly chemotherapy with docetaxel, gemcitabine and cisplatin in advanced transitional cell urothelial cancer: a phase II trial. [2022]To evaluate the efficacy and toxicity of a combination of weekly docetaxel, gemcitabine and cisplatin in advanced transitional cell carcinoma (TCC) of the bladder.
Phase II trial of gemcitabine and docetaxel in patients with advanced carcinoma of the urothelium: a trial of the Eastern Cooperative Oncology Group. [2022]Gemcitabine and docetaxel are active agents in advanced urothelial carcinoma. A Phase II trial of this combination was performed to determine the activity and toxicity of these agents in a multiinstitutional setting in patients previously treated with one prior chemotherapy regimen.
Gemcitabine plus vinorelbine chemotherapy in patients with advanced bladder carcinoma who are medically unsuitable for or who have failed cisplatin-based chemotherapy. [2022]To evaluate the efficacy and toxicity of gemcitabine plus vinorelbine chemotherapy in patients with advanced bladder carcinoma who are unsuitable for or who have failed cisplatin-containing chemotherapy.
Gemcitabine and docetaxel as first-line treatment for advanced urothelial carcinoma: a phase II study. [2022]The purpose of the study was to investigate the toxicity and efficacy of the combination of gemcitabine and docetaxel in untreated advanced urothelial carcinoma. Patients with previously untreated, locally advanced/recurrent or metastatic urothelial carcinoma stage-IV disease were eligible. Patients with Performance status: PS ECOG >3 or age >75 years or creatinine clearance
Sequential gemcitabine and cisplatin followed by docetaxel as first-line treatment of advanced urothelial carcinoma: a multicenter phase II study of the Hellenic Oncology Research Group. [2022]The purpose of this study was to investigate the toxicity and efficacy of the sequential administration of gemcitabine (GMB) in combination with cisplatin (CDDP) followed by docetaxel (Taxotere) as first-line treatment of advanced urothelial carcinoma.
Phase II California Cancer Consortium Trial of Gemcitabine-Eribulin Combination in Cisplatin-Ineligible Patients With Metastatic Urothelial Carcinoma: Final Report (NCI-9653). [2022]Patients with metastatic urothelial carcinoma are often ineligible for cisplatin-based treatments. A National Cancer Institute Cancer Therapy Evaluation Program-sponsored trial assessed the tolerability and efficacy of a gemcitabine-eribulin combination in this population.
Quality of Life, Efficacy, and Safety of Sequential Intravesical Gemcitabine + Docetaxel versus BCG for Non-Muscle Invasive Urinary Bladder Cancer: A Pilot Study. [2022]Bacille Calmette-Guerin (BCG) is considered the most effective agent for non-muscle invasive bladder cancer (NMIBC). However, due to BCG-related toxicity, multiple studies have suggested the role of newer chemotherapeutic drugs. The aim of our study was to evaluate intravesical gemcitabine + docetaxel (Gem/Doce) versus BCG with respect to quality of life (QOL), safety, and efficacy in NMIBC.
Comparison of Sequential Intravesical Gemcitabine and Docetaxel vs Bacillus Calmette-Guérin for the Treatment of Patients With High-Risk Non-Muscle-Invasive Bladder Cancer. [2023]Due to the ongoing bacillus Calmette-Guérin (BCG) shortage, sequential intravesical gemcitabine and docetaxel has been increasingly used as first-line therapy for high-risk non-muscle-invasive bladder cancer (NMIBC). However, data directly comparing these 2 therapies are lacking.