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| Sponsor: | Case Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Case Comprehensive Cancer Center |
| 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: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients With Renal Cell Carcinoma |
| Enrollment: | 32 |
| Study Start Date: | January 1999 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
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 Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Principal Investigator: | Scot C. Remick, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
| Responsible Party: | Scot C. Remick, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003928 History of Changes |
| Other Study ID Numbers: | CWRU3897, P30CA043703, CWRU-3897, NCI-G99-1530 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 9, 2010 |
| Health Authority: | United States: Federal Government |
|
stage IV renal cell cancer recurrent renal cell cancer |
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Gemcitabine Cisplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |