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Bladder CancerPhase 2NCT00045630

S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium

A Phase 2 study testing carboplatin, gemcitabine and paclitaxel in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by SWOG Cancer Research Network at 128 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells and decrease the need for surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
carboplatin, gemcitabine and paclitaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
128 sitesUnited States
Study dates
Jan 2003to Dec 2011
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed muscle-invasive (T2-T4a), node-negative (N0) urothelial transitional cell cancer (TCC) of the bladder
  • Focal squamous and/or adenocarcinoma differentiation, defined as ≤ 10% of tumor volume allowed
  • The following diagnoses are not allowed:
  • Small cell carcinoma
  • Sarcomatoid components
  • Disease diagnosed with an initial transurethral resection of bladder tumor (TURBT) and a second TURBT performed within 8 weeks of first with attempt to remove all tumor present
  • Residual disease after second TURBT allowed
  • No more than 14-56 days after second TURBT
  • No metastatic disease by chest x-ray and CT scan or MRI of the abdomen and pelvis
  • Fresh tumor tissue, paraffin tumor tissue, unstained slides, or cell block specimen from one or both TURBTs available

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • White blood cell count (WBC) at least 3,500/mm^3
  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least lower limit of normal

Hepatic

  • Bilirubin no greater than 1.5 mg/dL
  • Aspartate aminotransferase (SGOT) no greater than 2 times upper limit of normal

Renal

  • Creatinine no greater than 2.0 mg/dL AND/OR
  • Creatinine clearance at least 60 mL/min

Other

  • No prohibitive medical risk that would preclude radical cystectomy
  • No other serious concurrent systemic disorder that would preclude study compliance
  • No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer in complete remission, or any other cancer for which patient has been disease-free for 5 years
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior intravesical immunotherapy allowed

Chemotherapy

  • No prior systemic chemotherapy for TCC of the urothelium
  • Prior intravesical chemotherapy allowed

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy for TCC of the urothelium
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics

Trial locations and contacts

128 sites in 1 country.

128 sites in 1 country

United States128 sites

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • American Fork Hospital

    American Fork, Utah, 84003

  • Cancer Center at Providence Alaska Medical Center

    Anchorage, Alaska, 99519-6604

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Aurora, Colorado, 80045

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare

    Billings, Montana, 59101

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • St. James Community Hospital

    Butte, Montana, 59701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63701

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Shaw Cancer Center at Vail Valley Medical Center

    Edwards, Colorado, 81632

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Gape Girardeau, Missouri, 63701

  • Banner Thunderbird Medical Center

    Glendale, Arizona, 85306

  • Adirondack Cancer Care - Glens Falls

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Spectrum Health Hospital - Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Metropolitan Hospital

    Grand Rapids, Michigan, 49506

  • Big Sky Oncology

    Great Falls, Montana, 59405

  • Sletten Regional Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Foote Hospital

    Jackson, Michigan, 49201

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48909

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0293

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Logan Regional Hospital

    Logan, Utah, 84321

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • McKee Medical Center

    Loveland, Colorado, 80539

  • University of Tennessee Cancer Institute - Medical Center

    Memphis, Tennessee, 38104

  • Banner Desert Medical Center

    Mesa, Arizona, 85202

  • Banner Baywood Medical Center

    Mesa, Arizona, 85206

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Community Medical Center

    Missoula, Montana, 59801

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Montrose Memorial Hospital Cancer Center

    Montrose, Colorado, 81401

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Hackley Hospital

    Muskegon, Michigan, 49443

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Banner Good Samaritan Medical Center

    Phoenix, Arizona, 85006

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006

  • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Legacy Emanuel Hospital and Health Center & Children's Hospital

    Portland, Oregon, 97227

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Seton Cancer Institute - Saginaw

    Saginaw, Michigan, 48601

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • Latter Day Saints Hospital

    Salt Lake City, Utah, 84143

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • North Puget Oncology at United General Hospital

    Sedro-Woolley, Washington, 98284

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Christus Schumpert Cancer Treatment Center

    Shreveport, Louisiana, 71101

  • Providence Cancer Institute at Providence Hospital - Southfield Campus

    Southfield, Michigan, 48075

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98668

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wilson Medical Center

    Wilson, North Carolina, 27893-3428

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Forsyth Regional Cancer Center at Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Urothelial Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin With Molecular Correlates

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells and decrease the need for surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by observation or surgery to remove the bladder (cystectomy) in treating patients who have stage II or stage III cancer of the urothelium.

Read the detailed description

OBJECTIVES:

  • Determine the pathologic complete response of patients with stage II or III transitional cell cancer of the urothelium treated with neoadjuvant gemcitabine, paclitaxel, and carboplatin followed by observation or immediate cystectomy.
  • Determine, preliminarily, if molecular markers predict response, survival, and tumor recurrence in patients treated with these regimens.
  • Determine recurrence rates and cystectomy-free survival of patients who choose observation after an initial response to neoadjuvant chemotherapy.
  • Compare the survival of patients treated with neoadjuvant chemotherapy followed by cystectomy vs observation.
  • Determine the feasibility, tolerability, and toxicity of these regimens in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Within 4-8 weeks after completion of neoadjuvant chemotherapy, patients undergo a third transurethral resection of bladder tumor.

Patients with T0 disease after neoadjuvant chemotherapy may choose to undergo observation. These patients undergo cystoscopies with biopsies every 3 months for 1 year, every 4 months for 1 year, and then every 6 months until disease progression.

Patients with T1 disease or greater after neoadjuvant chemotherapy undergo immediate cystectomy. Patients with T0 disease may also choose this option. Patients undergoing immediate cystectomy are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 95 patients will be accrued for this study within 2 years.

Being tested
carboplatin, gemcitabine, paclitaxel, surgery
Keywords
anterior urethral cancer, localized transitional cell cancer of the renal pelvis and ureter, posterior urethral cancer, stage II bladder cancer, stage III bladder cancer, transitional cell carcinoma of the bladder, urethral cancer associated with invasive bladder cancer, regional transitional cell cancer of the renal pelvis and ureter
Medical subject headings
Urinary Bladder Neoplasms, Urethral Neoplasms

What participants receive

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

Study groups in NCT00045630
Study groupRoleWhat they receive
Gemcitabine, Paclitaxel, CarboplatinExperimentalGemcitabine, Paclitaxel, Carboplatin followed by surgery
Receives: Drug: carboplatin; Drug: gemcitabine; Drug: paclitaxel; Procedure: surgery

What is being measured

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

  1. Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy

    Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration.

    Measured: up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )

Secondary outcomes (2)

  1. Overall Survival (OS)

    Overall survival is defined from the date of registration to date of death from any cause

    Measured: 0-2 years

  2. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

    Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

    Measured: Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startJan 2003
  3. Primary completionMay 2008
  4. Study completionDec 2011

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
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00045630
Sponsor's protocol ID
CDR0000256921
Other IDs
S0219, U10CA032102
Status last verified
Apr 2013
First submitted
6 Sep 2002
Last updated
27 May 2013
Data monitoring committee
No

Publications

  • deVere White RW, Lara PN Jr, Goldman B, Tangen CM, Smith DC, Wood DP Jr, Hussain MH, Crawford ED. A sequential treatment approach to myoinvasive urothelial cancer: a phase II Southwest Oncology Group trial (S0219). J Urol. 2009 Jun;181(6):2476-80; discussion 2480-1. doi: 10.1016/j.juro.2009.01.115. Epub 2009 Apr 16.

    PubMed 19371909

  • Lara PN, Goldman B, De Vere White R, et al.: A sequential treatment approach to muscle-invasive urothelial cancer: A phase II Southwest Oncology Group trial (S0219) of neoadjuvant paclitaxel, carboplatin, and gemcitabine (PCG). [Abstract] J Clin Oncol 26 (Suppl 15): A-5022, 2008.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, gemcitabine and paclitaxel in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by SWOG Cancer Research Network at 128 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: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 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 27 May 2013). 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?

Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy (time frame: up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00045630, which also lists 2 linked publications.

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 27 May 2013.

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