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| Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003928 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well gemcitabine and cisplatin work in treating patients with metastatic kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients With Renal Cell Carcinoma |
| Estimated Enrollment: | 38 |
| Study Start Date: | January 1999 |
OBJECTIVES:
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 60 minutes on day 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 months.
PROJECTED ACCRUAL: Approximately 29-38 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Ohio | |
| Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Study Chair: | Scot C. Remick, MD | Case Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000067117, CWRU-3897, NCI-G99-1530 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003928 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV renal cell cancer recurrent renal cell cancer |
|
Antimetabolites Urinary Tract Neoplasm Kidney Cancer Immunologic Factors Urogenital Neoplasms Urologic Neoplasms Immunosuppressive Agents Antiviral Agents Recurrence Carcinoma |
Renal Cancer Radiation-Sensitizing Agents Cisplatin Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Gemcitabine Adenocarcinoma Neoplasms, Glandular and Epithelial |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Neoplasms by Site Urologic Diseases Cisplatin Kidney Neoplasms Therapeutic Uses |
Kidney Diseases Gemcitabine Neoplasms by Histologic Type Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Carcinoma, Renal Cell Adenocarcinoma Neoplasms, Glandular and Epithelial |