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NCT02178241 · REGISTRY CONDITION SEARCH

Gemcitabine Hydrochloride and Eribulin Mesylate in Treating Patients With Bladder Cancer That is Advanced or Cannot Be Removed by Surgery

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2019-12-16

This phase II trial studies how well gemcitabine hydrochloride and eribulin mesylate work in treating patients with bladder cancer that has spread to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and eribulin mesylate, 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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Observed Overall Response Rate

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Incidence of Adverse Events.

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Patients must have locally advanced or metastatic predominantly urothelial carcinoma of the bladder, ureter, or urethra that is not amenable to curative surgical treatment * Patients must have histologically confirmed predominantly urothelial carcinoma of the bladder, ureter, or urethra * Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam * Patients must be ineligible for treatment with cisplatin, based on one of: * Calculated creatinine clearance (CrCl) \>= 30 and \< 60 mL/min (Cockcroft-Gault) * CTCAE grade (Gr) \>= 2 hearing loss * CTCAE Gr \>= 2 neuropathy * Patients must not have received prior systemic therapy for their advanced cancer; prior intravesical therapy completed 4 weeks prior to enrollment and adjuvant/neoadjuvant chemotherapy completed more than 6 months prior to diagnosis of advanced disease are permitted * Zubrod performance status =\< 2 (Karnofsky \>= 60%) * Life expectancy of greater than 3 months * Leukocytes \>= 3,000/mcL * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Total bilirubin \< 1.5 times the upper limit of normal (x ULN) for the institution * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional upper limit of normal * Creatinine clearance; calculated creatinine clearance (CrCl) \>= 30 mL/min and \< 60 mL/min (Cockroft-Gault) unless the patient qualified based on hearing loss or neuropathy * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of gemcitabine and eribulin administration * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients with a small cell component in their histology are excluded * Patients who have had chemotherapy for the treatment of the advanced or unresectable urothelial cancer of the bladder are not eligible; patients who were previously treated for local disease must not have received radiotherapy or chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study and must have recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have received neoadjuvant or adjuvant chemotherapy must have completed treatment at least 6 months prior to diagnosis of metastatic disease * Patients who are receiving any other investigational agents * Patients with known brain metastases should be excluded from this clinical trial * History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and eribulin * Uncontrolled intercurrent illness including, but not limited to, a second cancer diagnosis within the past 5 years, or a cancer undergoing any treatment, 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 * Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with eribulin and gemcitabine * Human immunodeficiency virus (HIV)-positive patients with inadequate cluster of differentiation (CD)4 counts or those who are on combination antiretroviral therapy with strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) effects are ineligible for this trial * Patients with baseline corrected QT (QTc) prolongation greater than grade 1 are excluded from this study; patients with grade 1 QTc elevation are eligible but must be monitored with electrocardiogram (ECG) (EKG) exams, for the first 3 cycles of treatment; eribulin time to maximum concentration (Cmax) after infusion is about 10 minutes, and half life is 40 minutes; ECG (EKG) should be performed between 10 to 40 minutes after eribulin administration (on day 1 and day 8 of treatment); continued ECG (EKG) monitoring beyond cycle 3 can be done at the discretion of the treating physician * Patients with congenital long QT syndrome are excluded from this study * Other medications known to prolong QT interval should be discontinued and if not possible, patient is excluded from this study
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Eribulin Mesylate
    2. Drug: Gemcitabine Hydrochloride
    label
    Treatment (eribulin mesylate and gemcitabine hydrochloride)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (eribulin mesylate and gemcitabine hydrochloride)
    description
    Given IV
    name
    Eribulin Mesylate
    other Names
    1. B1939 Mesylate
    2. E7389
    3. ER-086526
    4. Halaven
    5. Halichondrin B Analog
    type
    DRUG
  2. arm Group Labels
    1. Treatment (eribulin mesylate and gemcitabine hydrochloride)
    description
    Given IV
    name
    Gemcitabine Hydrochloride
    other Names
    1. dFdCyd
    2. Difluorodeoxycytidine Hydrochloride
    3. FF 10832
    4. FF-10832
    5. FF10832
    6. Gemcitabine HCI
    7. Gemzar
    8. LY-188011
    9. LY188011
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
26
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Observed Overall Response Rate = Number of patients who experienced a confirmed CR or PR divided by the number of eligible patients who began treatment.
    measure
    Observed Overall Response Rate
    time Frame
    Up to 36 months
secondary Outcomes
  1. description
    Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
    measure
    Progression-free Survival
    time Frame
    From the start until progression, death, or the start of another treatment, assessed up to 12 months
  2. description
    Estimated using the product-limit method of Kaplan and Meier.
    measure
    Overall Survival
    time Frame
    From start of treatment until death from any cause ,up to 36 months
  3. description
    Toxicities that Occurred in 10% or More of Patients or At Least Once as a Grade 3+ Adverse Event (excluding those toxicities classified as "unrelated" or "unlikely related" to study drugs). Toxicities graded using CTCAEv4 criteria.
    measure
    Incidence of Adverse Events.
    time Frame
    Up to 36 months
Full study description
brief Summary
This phase II trial studies how well gemcitabine hydrochloride and eribulin mesylate work in treating patients with bladder cancer that has spread to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and eribulin mesylate, 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.
detailed Description
PRIMARY OBJECTIVES: I. To estimate the objective response rate of gemcitabine (gemcitabine hydrochloride)-eribulin (eribulin mesylate) (GE) when given to cisplatin ineligible patients with advanced or unresectable urothelial carcinoma who have not received any prior chemotherapy for the advanced disease. SECONDARY OBJECTIVES: I. To estimate the median progression-free survival (PFS). II. To summarize the toxicity profile (using Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 4 criteria) of the GE regimen in these patients. OUTLINE: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8 and eribulin mesylate IV over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 36 months.
Source references
references
  1. citation
    Sadeghi S, Groshen SG, Tsao-Wei DD, Parikh R, Mortazavi A, Dorff TB, Kefauver C, Hoimes C, Doyle L, Quinn DI, Newman E, Lara PN Jr. Phase II California Cancer Consortium Trial of Gemcitabine-Eribulin Combination in Cisplatin-Ineligible Patients With Metastatic Urothelial Carcinoma: Final Report (NCI-9653). J Clin Oncol. 2019 Oct 10;37(29):2682-2688. doi: 10.1200/JCO.19.00861. Epub 2019 Aug 7.
    pmid
    31390274
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        exact text
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      offset unit
      unicode_code_points
      query cond
      Urethral Cancer
      query disease state id
      ds-urethral-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-urethral-cancer-000.json
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    Preserved source evidence · Not medical advice