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Bladder CancerPhase 2NCT00268450

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

A Phase 2 study testing bevacizumab, cisplatin and gemcitabine hydrochloride in people with Bladder Cancer, run by Medical University of South Carolina at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Bladder Cancer
What is being tested?
bevacizumab, cisplatin and gemcitabine hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
4 sitesUnited States
Study dates
21 Sep 2005to Apr 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Lowcountry Hematology and Oncology, PA

    Mt. Pleasant, South Carolina, 29464-3233

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

Other trials in United States

About this study

Official title: A Phase II Study of Neo-Adjuvant Cisplatin, Gemcitabine & Bevacizumab, Followed by Radical Cystectomy for Patients With Muscle Invasive, Resectable, Non-Metastatic Transitional Cell Carcinoma (TCC) of the Bladder

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.

Conditions
Bladder Cancer
Keywords
transitional cell carcinoma of the bladder, stage III bladder cancer, stage II bladder cancer, recurrent bladder cancer
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumabBiological

    Also called avastin

    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

  • cisplatinDrug

    Before surgery: given as a 70mg/m2 IV over 60 minutes every 21 days for 4 cycles

  • gemcitabine hydrochlorideDrug

    Before surgery: given as a 1000mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle for 4 cycles

  • paclitaxelDrug

    After surgery: given as a 175 mg/m2 dose ver 3 hours every 21 days for 3 cycles

  • cysectomyProcedure or surgery

Study groups in NCT00268450
Study groupRoleWhat they receive
study interventionExperimentalNeo-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.
Receives: Biological: bevacizumab; Drug: cisplatin; Drug: gemcitabine hydrochloride; Drug: paclitaxel; Procedure: cysectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Remission Rate

    Measured: From day of first treatment until after cycle 3

Secondary outcomes (6)
  1. Urinary Survivin Levels

    Measured: Baseline, week 6 and week 12

  2. Urinary Cytogenitics

    Measured: baseline and week 12

  3. Progression Free Survival

    Measured: from first treatment until time of progression or death, whichever comes first

  4. Median Overall Surivial

    Measured: from first treatment until death

  5. Percentage of Planned Dose Received

    Measured: from first treatment until end of week 12

  6. Rate of Post-operative Complications

    Measured: from first treatment until up to 48 hours after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2005 (estimated)
  2. Study start21 Sep 2005
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00268450
Sponsor's protocol ID
CDR0000454937
Other IDs
MUSC-AVF-3312, MUSC-HR-15537, GENENTECH-AVF-3312, MUSC-CTO-100892
Status last verified
May 2018
First submitted
20 Dec 2005
Last updated
12 Jul 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, cisplatin and gemcitabine hydrochloride in people with Bladder Cancer, run by Medical University of South Carolina at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Remission Rate (time frame: From day of first treatment until after cycle 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.

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