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Status:

TERMINATED

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

Lead Sponsor:

Medical University of South Carolina

Conditions:

Bladder Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

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 di...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed transitional cell cancer (TCC) of the bladder
  • Staged as follows:
  • Muscle invasive (T2-T4a)
  • Node negative (N0)
  • No histologically or cytologically proven lymph node metastases
  • Nonmetastatic (M0)
  • No evidence of distant metastases
  • Resectable disease
  • Able to begin protocol treatment within 6 weeks after transurethral resection and cystoscopic evaluation
  • No central nervous system or brain metastases
  • PATIENT CHARACTERISTICS:
  • ECOG performance status of 0-2
  • Karnofsky 60-100%
  • White blood cell count ≥ 3,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • AST(SGOT) and ALT(SGPT) ≤ 2 times upper limit of normal
  • Bilirubin ≤1.5 mg/dL
  • Creatinine clearance ≥ 60 mL/min
  • Urine protein/creatinine ratio \< 1.0
  • Blood pressure ≤150/100 mm Hg
  • No prohibitive medical risks for chemotherapy
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, gemcitabine hydrochloride, or paclitaxel
  • No unstable angina
  • No history of myocardial infarction within the past 6 months
  • No cardiac arrhythmias
  • No New York Heart Association (NYHA) congestive heart failure ≥ grade 2
  • No history of stroke within the past 6 months
  • No clinically significant peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy
  • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No serious nonhealing wound, ulcer, or bone fracture
  • No psychiatric illness or other psychosocial situation that would limit ability to comply with study and/or follow-up procedures
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must agree to use adequate contraception prior to study entry and for the duration of study participation
  • No significant traumatic injury with in the past 28 days
  • PRIOR CONCURRENT THERAPY:
  • No prior systemic chemotherapy
  • No prior pelvic radiation therapy
  • More than 4 weeks since prior participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
  • No concurrent participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
  • No major surgical procedure or open biopsy within the past 28 days
  • No anticipation of need for major surgical procedure during the course of the study
  • No minor surgical procedures, fine-needle aspirations, or core biopsies within the past 7 days
  • No concurrent treatment with hormones or other chemotherapeutic agents except the following:
  • Steroids given for adrenal failure
  • Hormones administered for nondisease-related conditions (e.g., insulin for diabetes)
  • Intermittent use of dexamethasone as an antiemetic in solid tumor protocols
  • No other concurrent investigational or commercial agents or therapies

Exclusion

    Key Trial Info

    Start Date :

    September 21 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2012

    Estimated Enrollment :

    21 Patients enrolled

    Trial Details

    Trial ID

    NCT00268450

    Start Date

    September 21 2005

    End Date

    April 1 2012

    Last Update

    July 12 2018

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, United States, 29425

    2

    McLeod Regional Medical Center

    Florence, South Carolina, United States, 29501

    3

    Lowcountry Hematology and Oncology, PA

    Mt. Pleasant, South Carolina, United States, 29464-3233

    4

    Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, United States, 29303