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Bladder CancerPhase 2NCT00022633

S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract

A Phase 2 study testing gemcitabine hydrochloride and paclitaxel in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by SWOG Cancer Research Network at 92 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 use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and paclitaxel in treating patients who have advanced or recurrent… Read more about this study

Who is it for?
Ages Up to 120 years
What is being tested?
gemcitabine hydrochloride and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
92 sitesUnited States
Study dates
Jul 2001to Jul 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 Up to 120 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed urothelial cancer
  • Transitional cell carcinoma, adenocarcinoma, or squamous carcinoma (bladder, renal pelvis, ureter, or urethra)
  • Previously untreated metastatic or locoregionally advanced (i.e., bulky pelvic nodes) disease OR
  • Locally recurrent carcinoma after radiotherapy or cystectomy and no longer eligible for further radiotherapy or surgery
  • Measurable disease

PATIENT CHARACTERISTICS:

Age:

  • 70 and over OR
  • Under 60

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute granulocyte count at least 1,200/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than upper limit of normal (ULN)
  • Aspartate aminotransferase (SGOT) or alanine aminotransferase (SGPT) no greater than 2 times ULN

Renal:

  • Creatinine no greater than ULN

Other:

  • HIV negative
  • No other concurrent life-threatening medical disorder that would preclude study participation
  • No other prior 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 in complete remission
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Prior adjuvant chemotherapy is allowed provided administered more than 10 years ago
  • No prior gemcitabine, taxanes, or platinum-based adjuvant chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 28 days since prior radiotherapy and recovered

Surgery:

  • See Disease Characteristics
  • At least 28 days since prior surgery and recovered

Trial locations and contacts

92 sites in 1 country.

92 sites in 1 country

United States92 sites

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0942

  • 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

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • St. James Community Hospital

    Butte, Montana, 59701

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Finger Lakes Hematology and Oncology

    Clifton Springs, New York, 14432

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • 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

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Community Oncology Group at Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • 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

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Southwest Medical Center

    Liberal, Kansas, 67901

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

    Little Rock, Arkansas, 72205

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Tucker Center for Cancer Care at Orange Regional Medical Center

    Middletown, New York, 10940-4199

  • Community Medical Center

    Missoula, Montana, 59801

  • Clinic of Dr. Judy L. Schmidt

    Missoula, Montana, 59804

  • 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

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36652-2144

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Hackley Hospital

    Muskegon, Michigan, 49443

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Interlakes Oncology/Hematology PC

    Rochester, New York, 14623

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

    Rochester, New York, 14642

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78209

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • Cancer Therapy and Research Center

    San Antonio, Texas, 78229

  • University Hospital - San Antonio

    San Antonio, Texas, 78229

  • 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

  • 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 - Scott and White Hospital

    Temple, Texas, 76508

  • Stormont-Vail Cancer Center

    Topeka, Kansas, 66604

  • St. Francis Comprehensive Cancer Center

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Pearlman Comprehensive Cancer Center at South Georgia Medical Center

    Valdosta, Georgia, 31603

  • 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

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

Other trials in United States

About this study

Official title: Protocol for Assessment of Gemcitabine and Paclitaxel for Metastatic Urothelial Cancer in Patients Aged 70 Years or Older (and in a Cohort of Patients Younger Than 60 Years)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and paclitaxel in treating patients who have advanced or recurrent cancer of the urinary tract.

Read the detailed description

OBJECTIVES:

  • Determine the feasibility of enrolling patients aged 70 years and older with advanced or recurrent urothelial cancer to a structured phase II study.
  • Determine the anticancer efficacy of gemcitabine and paclitaxel, in terms of objective response rate and 2-year survival, in these elderly patients.
  • Assess the toxicity and tolerability of this regimen in these elderly patients.
  • Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status in these patients.
  • Determine the pharmacokinetics of this regimen in these elderly patients and validate this data against similar parameters in patients aged under 60 years.

OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over vs under 60).

Patients receive paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 80 patients (60 age 70 and over and 20 under age 60) will be accrued for this study.

Keywords
recurrent bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, squamous cell carcinoma of the bladder, adenocarcinoma of the bladder, recurrent urethral cancer, anterior urethral cancer, posterior urethral cancer, urethral cancer associated with invasive bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter, recurrent 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 NCT00022633
Study groupRoleWhat they receive
gemcitabine, paclitaxelExperimentalNot described
Receives: Drug: gemcitabine hydrochloride; Drug: paclitaxel

What is being measured

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

  1. Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols

    Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population.

    Measured: 66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)

Secondary outcomes (7)

  1. Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)

    Complete response (CR) is defined as complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial response (PR) applies only to patients with least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.

    Measured: every week for the first 4 weeks and then every 3 weeks for up to 19 weeks

  2. Progression-free Survival in Patients Aged 70 Years and Older

    Measured form date of registration to date of first observation of progression disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment.

    Measured: 0-5 years

  3. Overall Survival (OS) in Patients Aged 70 Years and Older

    Measured from date of registration to date of death due to any cause.

    Measured: 0-5 years

  4. 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 weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.

  5. Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate

    Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.

    Measured: at study entry (prior to administration of any treatment)

  6. Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms

    Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.

    Measured: at study entry (prior to administration of any treatment)

  7. Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required

    Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.

    Measured: at study entry (prior to administration of any treatment)

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 startJul 2001
  3. Primary completionJun 2008
  4. Study completionJul 2011

Why it stopped: Permanently Closed Due to Poor Accrual

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
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00022633
Sponsor's protocol ID
CDR0000068837
Other IDs
S0028, U10CA032102
Status last verified
Jul 2016
First submitted
10 Aug 2001
Last updated
11 Aug 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride and paclitaxel in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, 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: stopped early, as of the sponsor's last update on 11 Aug 2016. 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?

Yes. Results are posted in the registry (first posted 24 Feb 2016). 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?

Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols (time frame: 66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)). 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 NCT00022633.

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 11 Aug 2016.

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