Cisplatin, Bevacizumab, and Gemcitabine Followed by Surgery, Bevacizumab, and Paclitaxel in Treating Patients With Locally Advanced Nonmetastatic Bladder Cancer That Can Be Removed By Surgery

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT00268450
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
    Before surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 4 cycles After surgery: given as a 15mg/kg IV over 90 minutes every 21 days for 3 cycles
  • cisplatin — DRUG
    Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles
  • gemcitabine hydrochloride — DRUG
    Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles
  • paclitaxel — DRUG
    After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles
  • cysectomy — PROCEDURE

Study Details

RATIONALE: Drugs used in chemotherapy, such as cisplatin, gemcitabine, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving cisplatin, bevacizumab, and gemcitabine followed by surgery, bevacizumab, and paclitaxel works in treating patients with locally advanced nonmetastatic bladder cancer that can be removed by surgery.

Key Dates

First listed
Dec 22, 2005
Start date
Sep 21, 2005
Status verified
May 2018
Primary completion
Apr 30, 2012
Completion
Apr 30, 2012

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: study intervention
    Neo-adjuvant cisplatin, gemcitabine and bevacizumab followed by radical cystectomy. Patients without residual disease will enter follow up after surgery. Patients with residual disease will receive adjuvant therapy with bevacizumab and ciaplatin.

Primary Outcome Measure

Complete Remission Rate [ Time Frame: From day of first treatment until after cycle 3 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Hollings Cancer Center at Medical University of South CarolinaCharlestonSouth Carolina29425-
McLeod Regional Medical CenterFlorenceSouth Carolina29501-
Lowcountry Hematology and Oncology, PAMt. PleasantSouth Carolina29464-3233-
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburgSouth Carolina29303-

Find similar trials in Charleston, SC

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Hollings Cancer Center at Medical University of South Carolina· Charleston, SCMcLeod Regional Medical Center· Florence, SCLowcountry Hematology and Oncology, PA· Mt. Pleasant, SCGibbs Regional Cancer Center at Spartanburg Regional Medical Center· Spartanburg, SC

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