A Prospective Study of Neoadjuvant Chemotherapy With Gemcitabine/Platinum in Muscle-Invasive or Locally-Advanced Urothelial Carcinoma of Bladder

NCT03061630 | Unknown Phase 2 FDA Drug

• 1 other identifier: 2017-01-006
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

Previously-untreated, high-risk (\>T3 and/or N+) muscle-invasive bladder cancer (MIBC) cisplatin 60 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on days 1, 8 and 15. On day 1

Conditions

Urinary Bladder

Outcome Measures

Primary Outcomes (1)

• pathologic response

  to determine the antitumor activity of study treatment in terms of pathologic response

  30 months

Secondary Outcomes (1)

• progression-free survival

  30 months

Study Arms (1)

gemcitabine

EXPERIMENTAL

cisplatin 60 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on days 1, 8 and 15. On day 1

Drug: Gemcitabine; Drug: Cisplatin

Interventions

Gemcitabine DRUG

D1.8.15 : GEMCITABINE 1000MG/M2

gemcitabine

Cisplatin DRUG

D1: CISPLATIN 60G/M2

gemcitabine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be aged 20 years or more
• Must have histologically or cytologically proven UC of bladder.
• Must have histological evidence of high-risk muscle-invasive disease (i.e., T2\~ T4) or clinically N+ disease. They must be considered to have no other treatment options than radical cystectomy.
• Must have an ECOG performance status of 0 to 1
• Must have a life expectancy of 6 months or more
• At least 2 weeks since the last surgical procedures or biopsies prior to enrolment. Subjects must have recovered to \<Grade 2 from all acute toxicities or toxicity must be deemed irreversible by the investigator.
• Adequate marrow function without growth factor support or transfusion dependency
• Adequate renal function with serum creatinine 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault or MDRD formulas
• Adequate hepatic function
• Must agree to use an adequate method of contraception if the patient is sexually active, during and for 12 weeks after the completion of chemotherapy
• Written and voluntary informed consent understood, signed and dated.

You may not qualify if:

• Ongoing treatment with an anticancer agent not contemplated in this protocol
• Radiologic finding consistent with metastatic disease
• Severe medical or phychological illness that preclude participation to study, including any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years, (NYHA) grade III or greater congestive heart failure, cerebrovascular attack within the prior year, or current serious cardiac arrhythmia requiring medication except atrial fibrillation
• Non-tolerable \> Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1
• Major surgery, other than diagnostic surgery or transurethral resection, within 4 weeks prior to Cycle 1 Day 1, without complete recovery
• Double primary cancer of other site(s) or a history of other malignancies, except for cured ones at the discretion of investigator
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
• Subjects who have exhibited allergic reactions to study treatment
• Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study
• Subject with legal incapacity or limited legal capacity. Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. Unwillingness or inability to comply with the study protocol for any reason.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (2)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Samsung Medical Center

Seoul, 135710, South Korea

Location

MeSH Terms

Interventions

Gemcitabine; Cisplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• SEHOON PARK, MD,PhD

  SamsungMedicalCenter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Samsung Medical Center

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 23, 2017
• Study Start: February 15, 2017
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-03

Locations

KR (2)