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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003342 |
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: This phase I trial is studying the side effects of giving gemcitabine, doxorubicin, and paclitaxel together with carboplatin in treating patients with advanced bladder or kidney cancer and impaired kidney function.
Condition | Intervention | Phase |
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Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter |
Biological: filgrastim Drug: carboplatin Drug: doxorubicin hydrochloride Drug: gemcitabine hydrochloride Drug: paclitaxel |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of Dose-Dense Gemcitabine, Doxorubicin, Then Paclitaxel Plus Carboplatin In Patients With Transitional Cell Carcinoma of the Urothelium and Impaired Renal Function |
Estimated Enrollment: | 30 |
Study Start Date: | December 1997 |
OBJECTIVES:
OUTLINE: This is a dose escalation study of carboplatin.
Patients receive gemcitabine IV over 10 minutes and doxorubicin IV over 15 minutes for 5 doses on weeks 1, 3, 5, 7, and 9. Filgrastim (G-CSF) is given subcutaneously on days 3 through 10 of each 2-week course. On week 11, patients receive paclitaxel and carboplatin IV over 1 hour weekly for 12 weeks.
Each cohort of 3 patients is entered on sequentially increasing doses of carboplatin. If any patient experiences dose limiting toxicity (DLT), then 6 patients are entered at that dose level. If 3 patients experience DLT at any dose level, the maximum tolerated dose has been surpassed and a total of 6 patients are treated at the previous level.
Patients are evaluated at week 16 and at end of study.
PROJECTED ACCRUAL: There will be 18-30 patients accrued into this study over 9-15 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed advanced transitional cell urothelial cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
New York Weill Cornell Cancer Center at Cornell University | |
New York, New York, United States, 10021 |
Study Chair: | Dean F. Bajorin, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000066319, MSKCC-97114, NCI-G98-1438 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003342 History of Changes |
Health Authority: | United States: Federal Government |
stage III bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder |
metastatic transitional cell cancer of the renal pelvis and ureter localized 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 Anti-Bacterial Agents Renal Cancer Urologic Diseases Kidney Neoplasms Kidney Diseases Bladder Neoplasm Gemcitabine Kidney Cancer |
Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Antimitotic Agents Carboplatin Immunosuppressive Agents Antiviral Agents Doxorubicin Carcinoma Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Carcinoma, Renal Cell Antineoplastic Agents, Phytogenic Ureteral Neoplasms |
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 Antibiotics, Antineoplastic Neoplasms by Site Urologic Diseases Kidney Neoplasms |
Therapeutic Uses Kidney Diseases Gemcitabine Neoplasms by Histologic Type Mitosis Modulators Urinary Bladder Diseases Urinary Bladder Neoplasms Enzyme Inhibitors Antimitotic Agents Carboplatin Immunosuppressive Agents Antiviral Agents Doxorubicin Pharmacologic Actions Carcinoma |