Have you or your loved ones been diagnosed with non muscle invasive bladder cancer?

You may be eligible to participate in a non muscle invasive bladder cancer clinical trial.

Have you or your loved ones been diagnosed with non muscle invasive bladder cancer? You may be eligible to participate in a non muscle invasive bladder cancer clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Non Muscle Invasive Bladder Cancer Clinical Trial in Seoul

NCT02982395 | Phase 3 | Interventional

Have you or your loved ones been diagnosed with non muscle invasive bladder cancer?

You may be eligible to participate in a non muscle invasive bladder cancer clinical trial.

Have you or your loved ones been diagnosed with non muscle invasive bladder cancer? You may be eligible to participate in a non muscle invasive bladder cancer clinical trial.

Terminated

Male & Female

20 Years +

This study has recruited 36 Participants

The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of patients with recurrent Ta and T1 who experienced treatment failure with at least one prior BCG intravesical treatment.

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Details for the study

Brief Title

Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M In BCG Refractory NMIBC

Official Title

A Phase Ⅲ Study to Evaluate the Efficacy and Safety Of Intravesical Nanoxel®M (Docetaxel-PM) In Bacillius Calmette-Guerin Refractory Non-Muscle Invasive Bladder Cancer

Brief Summary

The purpose of this study is to determine whether Nanoxel®M is effective in the treatment of<br /> patients with recurrent Ta and T1 who experienced treatment failure with at least one prior<br /> BCG intravesical treatment.

Treatments and/or Procedures

Nanoxel m

Intravesical

Mitomycin C

Intravesical

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Recurrence free rate

Recurrence free rate will be summarized as the percentage of participants who achieved a confirmed recurrence free as assessed by urine cytology and cystoscopy. Recurrence means reappearance of high-risk disease (high grade, T1 or CIS) after the start of therapy.

1 year

Secondary

Recurrence free rate

Recurrence free rate will be summarized as the percentage of participants who achieved a confirmed recurrence free as assessed by urine cytology and cystoscopy.Recurrence means reappearance of high-risk disease (high grade, T1 or CIS) after the start of therapy.

6 months, 2 years

Secondary

Overall survival

Time from random assignment to death resulting from any cause.

2 years

Secondary

Number of participants with adverse events as assessed by CTCAE v4.0

Adverse event (AE) is as any AE occurring or worsening from the first treatment of any study drug to the last dose of the last study drug. Severity grades according to NCI CTCAE version 4.0.

2 years

Study Criteria

Inclusion Criteria:

  -  Histologically confirmed diagnosis of superficial transitional cell carcinoma of the
     bladder (Ta, T1)

  -  Recurrent superficial bladder cancer refractory to Bacillus Calmette-Guerin (BCG)

  -  No previous intravesical therapy for 6 weeks

  -  No history of prior radiation to the pelvis

  -  Peripheral neuropathy ≤ grade 1

  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 t0 2

  -  Adequate hematopoietic and hepatic parameters

Exclusion Criteria:

  -  Muscle invasive disease (T2-T4)

  -  Any other malignancy diagnosed within 2 years of study entry (Except basal or squamous
     cell skin cancers or noninvasive cancer of the cervix)

  -  Participation in any other research protocol involving administration of an
     investigational agent within 3 months before study entry

  -  History of sensitivity reaction to docetaxel

  -  Prescribed immunosuppressive medications because of a confounding medical condition

  -  Female patients who were pregnant or lactating