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

This study has been terminated.
(Permanently Closed Due to Poor Accrual)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
First received: August 10, 2001
Last updated: October 5, 2012
Last verified: October 2012

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.

Condition Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Study treatment feasibility [ Time Frame: monthly for duration of accrual ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (confirmed and unconfirmed complete and partial response) [ Time Frame: at weeks 10 and 19, then every 3 months for first year, and every 6 months for 3 years ] [ Designated as safety issue: No ]
  • Survival at 2 years [ Time Frame: at weeks 10 and 19, then every 6 months for 2 years ] [ Designated as safety issue: No ]
  • Toxicity and tolerability [ Time Frame: weeks 1-5, 7, 8, 10, 11, 13, 14, 16, 17, 19 ] [ Designated as safety issue: Yes ]
  • Feasibility of standardized self-report measures of comorbidity, depression, and functional status [ Time Frame: upon completion of patient accrual ] [ Designated as safety issue: No ]
  • Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age [ Time Frame: upon completion of patient accrual ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: July 2001
Study Completion Date: July 2011
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gemcitabine, paclitaxel Drug: gemcitabine hydrochloride Drug: paclitaxel
Other Name: Taxol

Detailed Description:


  • 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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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



  • 70 and over OR
  • Under 60

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified


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


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


  • Creatinine no greater than ULN


  • 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


Biologic therapy:

  • Not specified


  • 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


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


  • See Disease Characteristics
  • At least 28 days since prior surgery and recovered
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022633

  Show 92 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Derek Raghavan, MD, PhD, FRACP, FACP The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00022633     History of Changes
Other Study ID Numbers: CDR0000068837  S0028  U10CA032102 
Study First Received: August 10, 2001
Last Updated: October 5, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
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

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Kidney Neoplasms
Ureteral Neoplasms
Urinary Bladder Neoplasms
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Ureteral Diseases
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 11, 2016