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Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
This study is ongoing, but not recruiting participants.
First Received: January 28, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004223
  Purpose

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.


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

Genetics Home Reference related topics: bladder cancer
MedlinePlus related topics: Bladder Cancer Cancer
Drug Information available for: Gemcitabine Docetaxel Gemcitabine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Trial of Gemcitabine and Docetaxel in Advanced Carcinoma of the Urothelium

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004223

  Show 76 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Robert Dreicer, MD, FACP The Cleveland Clinic
  More Information

Additional Information:
Publications:
Dreicer R, Manola J, Schneider DJ, Schwerkoske JF, George CS, Roth BJ, Wilding G; Eastern Cooperative Oncology Group. Phase II trial of gemcitabine and docetaxel in patients with advanced carcinoma of the urothelium: a trial of the Eastern Cooperative Oncology Group. Cancer. 2003 Jun 1;97(11):2743-7.
Manola JB, Dreicer R, Wilding G, et al.: Gemcitabine and docetaxel in advanced carcinoma of the urothelium: report of a phase II Eastern Cooperative Oncology Group trial . [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-796, 2002.

Study ID Numbers: CDR0000067464, E-2899
Study First Received: January 28, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004223     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III bladder cancer
recurrent bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder
posterior urethral cancer
metastatic transitional cell cancer of the renal pelvis and ureter
regional transitional cell cancer of the renal pelvis and ureter

Study placed in the following topic categories:
Antimetabolites
Urinary Tract Neoplasm
Immunologic Factors
Ureteral Diseases
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Docetaxel
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Urethral Cancer
Kidney Diseases
Bladder Neoplasm
Gemcitabine
Kidney Cancer
Cystocele
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Immunosuppressive Agents
Antiviral Agents
Recurrence
Carcinoma
Radiation-Sensitizing Agents
Urethral Neoplasms
Ureteral Neoplasms
Neoplasms, Glandular and Epithelial
Transitional Cell Carcinoma

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Ureteral Diseases
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Docetaxel
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Urethral Diseases
Kidney Diseases
Gemcitabine
Neoplasms by Histologic Type
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Urethral Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009