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Bladder CancerPhase 2NCT00055835

S0121, Neoadjuvant Carboplatin, Paclitaxel, and Gemcitabine Followed by Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced or Recurrent Carcinoma of the Urothelium

A Phase 2 study testing carboplatin, cisplatin and gemcitabine hydrochloride in people with Bladder Cancer and Urethral Cancer, run by SWOG Cancer Research Network at 92 sites in United States.

Completed

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

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer, Urethral Cancer
What is being tested?
carboplatin, cisplatin and gemcitabine hydrochloride
How many people
7 participants
Where
92 sitesUnited States
Study dates
Nov 2002to Jun 2006
Phase
Phase 2
Are there results?
None posted in the registry

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 primary or recurrent invasive carcinoma of the urothelium
  • Transitional, squamous, or mixed cell subtypes allowed
  • Primary disease site must be the urinary bladder or urethra
  • Disease confined to the true pelvis (T2-T4, N0-N3, M0)
  • Must meet at least 1 of the following criteria:
  • Nodal involvement at or below the level of the bifurcation of the iliac vessels
  • Medically or surgically inoperable
  • Patient refused cystectomy
  • Measurable or nonmeasurable disease
  • Evidence of tumor invasion of the muscularis by cystoscopy and biopsy and detailed bladder mapping within the past 56 days
  • No extrapelvic metastases
  • Eligible to receive radiotherapy
  • Planned radiotherapy at a SWOG-approved facility

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least lower limit of normal

Hepatic

  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2.5 times ULN

Renal

  • Creatinine clearance at least 60 mL/min OR
  • Creatinine no greater than ULN

Gastrointestinal

  • No chronic diarrhea
  • No malabsorption
  • No extensive diverticular disease of the colon
  • No inflammatory bowel disease
  • No other pre-existing gastrointestinal disorders

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No active infections requiring antibiotics
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for patients with a current diagnosis of advanced bladder cancer that is also the initial diagnosis
  • No prior systemic chemotherapy except adjuvant therapy for recurrent disease completed more than 6 months ago
  • No prior carboplatin
  • No prior paclitaxel
  • No prior gemcitabine

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior pelvic radiotherapy

Surgery

  • See Disease Characteristics
  • Recovered from prior surgery

Trial locations and contacts

92 sites in 1 country.

92 sites in 1 country

United States92 sites

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico, 87108-5138

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • Texas Tech University Health Sciences Center School of Medicine

    Amarillo, Texas, 79106

  • Veterans Affairs Medical Center - Amarillo

    Amarillo, Texas, 79106

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0946

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

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

    Aurora, Colorado, 80010

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Western New York Urology Associates

    Buffalo, New York, 14220

  • Veterans Affairs Medical Center - Charleston

    Charleston, South Carolina, 29401-5799

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Veterans Affairs Medical Center - Chicago Westside Hospital

    Chicago, Illinois, 60612

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220-2288

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267-0501

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195-9001

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428-1002

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan, 48201-1932

  • Josephine Ford Cancer Center at Henry Ford Health System

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234-6200

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • CCOP - Southeast Cancer Control Consortium

    Goldsboro, North Carolina, 27534-9479

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois, 60141

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4095

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi, 39216

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

    Kansas City, Kansas, 66160-7390

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40502-2236

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0084

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Veterans Affairs Medical Center - Little Rock

    Little Rock, Arkansas, 72205

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

  • UMC Southwest Cancer and Research Center

    Lubbock, Texas, 79415-3364

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California, 94553

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153-5500

  • University of Tennessee Cancer Institute at Methodist Central Hospital

    Memphis, Tennessee, 38104

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36607

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane Cancer Center at Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • NYU Cancer Institute at New York University Medical Center

    New York, New York, 10016

  • Herbert Irving Comprehensive Cancer Center at Columbia University

    New York, New York, 10032

  • Sentara Cancer Institute at Sentara Norfolk General Hospital

    Norfolk, Virginia, 23510-1115

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

    Orange, California, 92868

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006-2726

  • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

    Phoenix, Arizona, 85012

  • Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97201-3098

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112-5550

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah, 84148

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78229

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

  • Puget Sound Oncology Consortium

    Seattle, Washington, 98109

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana, 71101-4295

  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences

    Shreveport, Louisiana, 71130-3932

  • Providence Cancer Institute at Providence Hospital - Southfield Campus

    Southfield, Michigan, 48075

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • Saint Louis University Cancer Center

    St Louis, Missouri, 63110

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • CCOP - Northwest

    Tacoma, Washington, 98405-0986

  • Veterans Affairs Medical Center - Tampa (Haley)

    Tampa, Florida, 33612

  • Veterans Affairs Medical Center - Temple

    Temple, Texas, 76504

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona, 85723

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • MBCCOP - Howard University Cancer Center

    Washington D.C., District of Columbia, 20060

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas, 67218

Other trials in United States

About this study

Official title: Phase II Evaluation of Carboplatin, Paclitaxel and Gemcitabine Followed by Concurrent Cisplatin and Radiation Therapy in Patients With Locally Advanced or Recurrent Urothelial Malignancy

RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy before radiation therapy, and combining chemotherapy with radiation therapy, may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of neoadjuvant gemcitabine, paclitaxel, and carboplatin followed by cisplatin and radiation therapy in treating patients who have locally advanced or recurrent carcinoma (cancer) of the urothelium.

Read the detailed description

OBJECTIVES:

  • Determine the overall survival of patients with locally advanced or recurrent carcinoma of the urothelium treated with neoadjuvant carboplatin, paclitaxel, and gemcitabine followed by concurrent cisplatin and radiotherapy.
  • Determine the feasibility of administering this regimen to these patients.
  • Determine the progression-free survival of patients treated with this regimen.
  • Determine the qualitative and quantitative toxic effects of this regimen in these patients.
  • Determine the response rate (confirmed and unconfirmed) of patients treated with the neoadjuvant regimen and those treated with the whole regimen.
  • Determine the proportion of patients who qualify for concurrent cisplatin and radiotherapy after receiving the neoadjuvant regimen.
  • Determine the potential value of suppressor gene expression analysis (p53 and retinoblastoma gene) and HER2 expression as indicators of prognosis and/or response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive neoadjuvant chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 15 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity.

Within 4-8 weeks after the completion of neoadjuvant chemotherapy, patients receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for a maximum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo concurrent radiotherapy 5 days a week for 6 weeks.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 4 years.

Keywords
recurrent bladder cancer, stage III bladder cancer, squamous cell carcinoma of the bladder, stage II bladder cancer, recurrent urethral cancer, urethral cancer associated with invasive bladder cancer, distal urethral cancer, proximal urethral cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder
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.

  • carboplatinDrug

    Also called Paraplatin

    *AUC=5 (by modified Calvert formula), IV, over 15 minutes; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days)

  • cisplatinDrug

    Also called Platinol; CDDP

    75 mg/m2 (maximum dose 150 mg), IV, rapid infusion; given q 21 days for 2 cycles (1 cycle = 21 days)

  • gemcitabine hydrochlorideDrug

    Also called Gemzar

    800 mg/m2, IV, over 30 minutes; given on Days 1 \& 8, q 21 days, for a maximum of 3 cycles (1 cycle = 21 days)

  • paclitaxelDrug

    Also called Taxol

    200 mg/m2, IV, over 3 hours; given q 21 days for a maximum of 3 cycles (1 cycle = 21 days)

  • neoadjuvant therapyProcedure or surgery

    Neoadjuvant chemotherapy (paclitaxel, carboplatin, and gemcitabine)

  • radiation therapyRadiation

    Radiation treatments will be delivered once daily. Treatment will be given 5 days per week at a dose of 180 to 200 cGy per day. All fields will be treated everyday.

Timeline

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

  1. First posted7 Mar 2003 (estimated)
  2. Study startNov 2002
  3. Primary completionJun 2006
  4. Study completionJun 2006

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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00055835
Sponsor's protocol ID
CDR0000271309
Other IDs
S0121, U10CA032102
Status last verified
Jan 2013
First submitted
6 Mar 2003
Last updated
31 Jan 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, cisplatin and gemcitabine hydrochloride in people with Bladder Cancer and Urethral Cancer, run by SWOG Cancer Research Network at 92 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 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00055835.

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 31 Jan 2013.

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