Combination Chemotherapy Following Surgery in Treating Patients With Advanced Bladder Cancer
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| ClinicalTrials.gov Identifier: NCT00003133 |
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Recruitment Status :
Completed
First Posted : April 30, 2004
Last Update Posted : June 28, 2013
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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 combination chemotherapy following surgery in treating patients with advanced bladder cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter | Biological: filgrastim Drug: cisplatin Drug: doxorubicin hydrochloride Drug: gemcitabine hydrochloride Drug: paclitaxel | Phase 1 |
OBJECTIVES: I. Determine the safety and toxicity of sequential dose intensive adjuvant systemic therapy consisting of gemcitabine, then doxorubin, followed by paclitaxel and cisplatin with filgrastim (granulocyte colony stimulating factor; G-CSF) for patients with completely resected, locally advanced transitional cell carcinoma of the urothelium. II. Assess the disease free and overall survival of these patients.
OUTLINE: Patients receive gemcitabine IV on weeks 1, 2, 3, 5, 6, and 7 for a total of 6 doses. A 1 week rest period occurs after the third dose of gemcitabine. At least 14 days after the last dose of gemcitabine, during the ninth week, patients receive doxorubicin at 2 week intervals (weeks 9, 11, 13, and 15) for a total of 4 doses. Filgrastim (granulocyte colony stimulating factor; G-CSF) is administered subcutaneously on days 3-10 of each cycle of doxorubicin. At least 14 days after the last dose of doxorubicin, during week 17, patients receive the combination of paclitaxel IV (3 hour infusion) and cisplatin, at 2 week intervals (weeks 17, 19, 21, and 23) for a total of 4 doses. G-CSF is again administered on days 3-10 of each of these cycles. Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, then annually until death.
PROJECTED ACCRUAL: This study will accrue 25-30 patients in 1.5-2 years.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Primary Purpose: | Treatment |
| Official Title: | Sequential Gemcitabine, Doxorubicin, Then Paclitaxel Plus Cisplatin Adjuvant Chemotherapy After Complete Resection of Locally Advanced Transitional Cell Carcinoma of the Urothelium |
| Study Start Date : | September 1997 |
| Actual Primary Completion Date : | January 2003 |
| Actual Study Completion Date : | January 2003 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Pathologically proven complete resection of locally advanced transitional cell carcinoma of the urothelium with negative margins Disease extends beyond the bladder, the ureter, or into the regional lymph nodes Stages eligible for patients with bladder cancer: Tany, N+, M0 T3b, N0, M0 T4a, N0, M0 Stages eligible for patients with urothelial cancer of the renal pelvis or ureter: Tany, N+, M0 T3, N0, M0 T4, N0, M0 Local control of primary urothelial tumor obtained by: Cystoprostatectomy plus pelvic lymph node dissection for bladder cancer in males Cystectomy/TAH/BSO and pelvic lymph node dissection for bladder cancer in females Nephroureterectomy for disease involving the renal pelvis or ureter
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% ECOG 0-1 Life expectancy: Not specified Hematopoietic: Platelet count at least 150,000/mm3 Granulocyte count at least 1500/mm3 Hepatic: Bilirubin less than 1.5 times normal SGOT and alkaline phosphatase less than 2 times normal Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/ min Cardiovascular: LVEF at least 50% No New York Heart Association class II or IV heart disease No serious cardiac arrhythmias, including first, second, or third degree heart block Other: No concurrent second malignancy except nonmelanomatous skin cancer or curatively treated in situ carcinoma of the cervix No uncontrolled infection Fertile patients must use barrier method contraception before, during, and for 6 months after therapy and are encouraged to continue barrier method contraception for 2 years or longer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior irradiation of the bladder Surgery: See Disease Characteristics Definitive surgery performed within 10 weeks of study treatment start
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003133
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Dean F. Bajorin, MD | Memorial Sloan Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003133 History of Changes |
| Other Study ID Numbers: |
97-106 CDR0000065899 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-G97-1358 |
| First Posted: | April 30, 2004 Key Record Dates |
| Last Update Posted: | June 28, 2013 |
| Last Verified: | June 2013 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
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stage III bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder metastatic transitional cell cancer of the renal pelvis and ureter regional transitional cell cancer of the renal pelvis and ureter |
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms Carcinoma, Transitional Cell Kidney Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Kidney Diseases Ureteral Diseases |
Paclitaxel Gemcitabine Liposomal doxorubicin Albumin-Bound Paclitaxel Cisplatin Doxorubicin Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents |