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Invasive Bladder Cancer | Neoadjuvant Gemcitabine and Fractionated, Weekly Cisplatin For Muscle Invasive Bladder Cancer and Patients Not Candidates For High Dose Cisplatin

Invasive Bladder Cancer research study

What is the primary objective of this study?

The standard treatment of muscle invasive bladder cancer is to administer chemotherapy for approximately 3 months then to have surgery to remove the bladder. Chemotherapy may reduce the size of the cancer in your bladder before surgery and can also help to reduce the chance that your bladder cancer will come back (metastasize) in other parts of your body after bladder surgery. This study will involve testing cisplatin in lower weekly doses with gemcitabine.The purpose of this study is to test the effects, good and bad, of low dose weekly cisplatin and gemcitabine.

Who is eligible to participate?

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Invasive Bladder Cancer

Bladder Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Gemcitabine and fractionated cisplatin (combination treatment)1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Gemcitabine and fractionated cisplatin (combination treatment)1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8

Study Status

Terminated

Start Date: July 2014

Completed Date: June 2015

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Pathologic Complete Response Rate of Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Muscle Invasive Bladder Cancer Whom Are Not Candidates for High Dose Cisplatin.

Secondary Outcome: Number of Participants Experiencing Toxicities With Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Bladder Cancer

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Brown University

Collaborator: Lifespan

More information:https://clinicaltrials.gov/show/NCT02030574

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