Skip to content
Triangle logo TriangleGet started
← Study library

NCT01611662 · REGISTRY CONDITION SEARCH

Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer

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
TERMINATED
Registry last update
2019-07-29

The purpose of this research study is to find out what effects, good and/or bad, dose-dense (every 14 days) chemotherapy with gemcitabine (gemcitabine hydrochloride) and cisplatin given before surgery have on patients and their muscle invasive bladder cancer.

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

→

baseline

Baseline characteristics

→

outcome · POSTED

Pathological Complete Response Rate Following Chemotherapy Before Surgery

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Patients must have histologically confirmed urothelial carcinoma of the bladder or urethra; patients with urothelial carcinoma of the prostatic urethra only may be included at primary investigator (PI) discretion; T-stage must be T2 to T4a; patients with radiographic N0 disease or N1 disease are eligible for the study; patients must not have radiographic evidence of metastatic disease; mixed histologies which are predominantly urothelial, such as with squamous or micropapillary differentiation, are allowed so long as there is no component of small cell histology; histology must be confirmed by a pathologist at an institution involved in this study * Patients must be candidates for radical cystectomy with the goal of cure * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Leukocytes \>= 3,000/mcL * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Total bilirubin =\< institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional ULN * Patients must have adequate renal function defined as creatinine clearance \>= 50 mL/min; for eligibility, creatinine clearance may be either calculated using the Cockcroft-Gault formula or measured with 24 hour urine collection; note that 24 hour urine collection is required at baseline, but does not have to be used for eligibility if calculated clearance by Cockcroft-Gault is preferred; nephrostomy or ureteral stent placement in order to achieve adequate creatinine clearance is allowed * Women of child-bearing potential (WOCBP) and men with a female partner who is a WOCBP must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) starting prior to beginning treatment and continuing until at least 3 months after last dose of chemotherapy and surgery; should a woman become pregnant or suspect she is pregnant while participating in this study or if a female partner of a man participating in this study becomes pregnant, the treating physician must be notified immediately; WOCBP must have a negative serum or urine pregnancy test within 7 days prior to initiating study treatment * No other active malignancy * Ability to understand and the willingness to sign written informed consent and Health Insurance Portability and Accountability Act (HIPAA) documents Exclusion Criteria: * Patients who have had intravesicular therapy within 4 weeks of study entry, or those who have not recovered from adverse effects of such agents administered more than 4 weeks earlier * Patients may not be receiving any investigational agents within 4 weeks of study entry * History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or cisplatin or other agents used in the study * 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 * Pregnant women are excluded from this study * Known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible * Patients who have undergone prior radiation to greater than or equal to 25% of the bone marrow within the past year are excluded * Patients who have received any previous systemic chemotherapy or radiation therapy for urothelial carcinoma within 1 year of study entry are ineligible
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 day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.
    intervention Names
    1. Drug: gemcitabine hydrochloride
    2. Drug: cisplatin
    3. Procedure: therapeutic conventional surgery
    4. Other: laboratory biomarker analysis
    label
    Treatment (gemcitabine hydrochloride, cisplatin, surgery)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (gemcitabine hydrochloride, cisplatin, surgery)
    description
    Given IV
    name
    gemcitabine hydrochloride
    other Names
    1. dFdC
    2. difluorodeoxycytidine hydrochloride
    3. gemcitabine
    4. Gemzar
    type
    DRUG
  2. arm Group Labels
    1. Treatment (gemcitabine hydrochloride, cisplatin, surgery)
    description
    Given IV
    name
    cisplatin
    other Names
    1. CACP
    2. CDDP
    3. CPDD
    4. DDP
    type
    DRUG
  3. arm Group Labels
    1. Treatment (gemcitabine hydrochloride, cisplatin, surgery)
    description
    Undergo radical cystectomy
    name
    therapeutic conventional surgery
    type
    PROCEDURE
  4. arm Group Labels
    1. Treatment (gemcitabine hydrochloride, cisplatin, surgery)
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
32
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Pathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy
    measure
    Pathological Complete Response Rate Following Chemotherapy Before Surgery
    time Frame
    Up to 5 years
Full study description
brief Summary
The purpose of this research study is to find out what effects, good and/or bad, dose-dense (every 14 days) chemotherapy with gemcitabine (gemcitabine hydrochloride) and cisplatin given before surgery have on patients and their muscle invasive bladder cancer.
detailed Description
PRIMARY OBJECTIVES: I. To assess the rate of complete response (pT0) at cystectomy following preoperative dose dense gemcitabine and cisplatin (DD GC) in patients with muscle invasive urothelial carcinoma of the bladder. SECONDARY OBJECTIVES: I. To assess the toxicity profile of DD GC when given in the neoadjuvant setting: To define the number of patients who complete all three cycles of treatment without dose reduction, and to describe the incidence of toxicity. II. To assess the 5 year overall and relapse free survival in patients who receive neoadjuvant DD GC. TERTIARY OBJECTIVES: I. To evaluate tissue specimens from patients to assess for molecular markers that correlate with clinical outcome. OUTLINE: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy. After completion of study treatment, patients are followed up for 5 years.
Source references
references
  1. citation
    Satyal U, Valentine H, Liu D, Slifker M, Lallas CD, Trabulsi EJ, Bukavina L, Szeto L, Hoffman-Censits JH, Mouw KW, Faltas BM, Grivas P, Ibragimova I, Porten SP, Van Allen EM, Geynisman DM, Parker DC, O'Neill JP, Drevik J, Christianson SS, Ginzburg S, Correa AF, Uzzo RG, Ross EA, Zibelman MR, Ghatalia P, Plimack ER, Kutikov A, Abbosh PH. Urine Biopsy as Dynamic Biomarker to Enhance Clinical Staging of Bladder Cancer in Radical Cystectomy Candidates. JCO Precis Oncol. 2024 Jun;8:e2300362. doi: 10.1200/PO.23.00362.
    pmid
    38865671
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-4ad13844694114c54063
      requested nct id
      NCT01611662
      primary nct id
      NCT01611662
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      308f79635904744c3081b7bece1bbf864685110f5917c0840a211e0e58d7fefc
      payload sha256
      4a422e090311bfc36f39534a09f3569c5803925f3c424ecfc83d6d107f5ed112
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-4ad13844694114c54063
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01611662
      occurrences
      1. context exact
        NCT01611662
        end
        11
        exact text
        NCT01611662
        start
        0
      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
      source file sha256
      308f79635904744c3081b7bece1bbf864685110f5917c0840a211e0e58d7fefc
      source json pointer
      /studies/27/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      7dc710b909d2010edb11b7f7aae7f41dc0dbb302e7732bb8fc99c493b17462dc

    Preserved source evidence · Not medical advice