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Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer

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ClinicalTrials.gov Identifier: NCT00004223
Recruitment Status : Completed
First Posted : February 25, 2004
Last Update Posted : January 27, 2010
Information provided by:

January 28, 2000
February 25, 2004
January 27, 2010
December 1999
October 2002   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004223 on ClinicalTrials.gov Archive Site
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Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
Phase II Trial of Gemcitabine and Docetaxel in Advanced Carcinoma of the Urothelium

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.

PURPOSE: Phase II trial to study the effectiveness of docetaxel and gemcitabine in treating patients who have progressive regional or metastatic bladder cancer.

OBJECTIVES: I. Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium and failure of only 1 prior systemic regimen treated with docetaxel and gemcitabine. II. Determine the toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1 and 8. For patients with complete or partial response or stable disease at 3 weeks, treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months through year 2, every 6 months through year 5, and then annually thereafter until disease progression.

PROJECTED ACCRUAL: A total of 22-45 patients will be accrued for this study over 18-21 months.

Phase 2
Primary Purpose: Treatment
  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • Drug: docetaxel
  • Drug: gemcitabine hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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October 2002   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically proven progressive regional or metastatic transitional cell carcinoma of the urothelium or mixed histology containing a component of transitional cell carcinoma Failure of only 1 prior chemotherapy regimen for metastatic disease or in the adjuvant or neoadjuvant setting (not containing taxane or gemcitabine) Bidimensionally measurable disease No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase normal OR Alkaline phosphatase no greater than 4 times ULN if SGOT normal OR SGOT less than 1.5 times ULN AND alkaline phosphatase less than 2.5 times ULN Renal: Creatinine no greater than 1.8 mg/dL Cardiovascular: No American Heart Association class III or IV heart disease No uncontrolled congestive heart failure No severe cardiac arrhythmias Neurologic: No sensory neuropathy grade 3 or 4 No prior peripheral neuropathy grade 2 or worse Other: No active unresolved infection being treated with parenteral antibiotics within the past 7 days No other malignancy within the past 5 years except: Curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix Clinically unsuspected, organ confined prostate cancer found during cystoprostatectomy Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic response modifier therapy Prior intravesical BCG allowed Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   South Africa,   United States
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Group Chair, Eastern Cooperative Oncology Group
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Robert Dreicer, MD, FACP The Cleveland Clinic
Eastern Cooperative Oncology Group
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP