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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004223 |
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 |
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Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: docetaxel Drug: gemcitabine hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial of Gemcitabine and Docetaxel in Advanced Carcinoma of the Urothelium |
Study Start Date: | December 1999 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Study Chair: | Robert Dreicer, MD, FACP | The Cleveland Clinic |
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 |
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 |
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 |
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 |