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Sponsored by: |
Case Comprehensive Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00401128 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with irinotecan works in treating patients with metastatic kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Gemcitabine Plus Irinotecan in Patients With Metastatic Renal Cell Carcinoma |
Estimated Enrollment: | 30 |
Study Start Date: | May 2004 |
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive gemcitabine hydrochloride IV over 30 minutes and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No history of any of the following:
No other prior malignancy except for the following:
PRIOR CONCURRENT THERAPY:
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | Ronald M. Bukowski, MD | The Cleveland Clinic |
Study ID Numbers: | CDR0000446096, CASE-CCF-6695 |
Study First Received: | November 16, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00401128 History of Changes |
Health Authority: | United States: Federal Government |
clear cell renal cell carcinoma recurrent renal cell cancer papillary renal cell carcinoma stage IV renal cell cancer |
Antimetabolites Urinary Tract Neoplasm Anti-Infective Agents Immunologic Factors Irinotecan Urogenital Neoplasms Urologic Neoplasms Renal Cancer Urologic Diseases Kidney Neoplasms Kidney Diseases Gemcitabine Kidney Cancer |
Chromophil Renal Cell Carcinoma Antiviral Agents Immunosuppressive Agents Recurrence Camptothecin Carcinoma Papillary Renal Cell Carcinoma Radiation-Sensitizing Agents Clear Cell Renal Cell Carcinoma Carcinoma, Renal Cell Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Irinotecan Urogenital Neoplasms Urologic Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Kidney Diseases |
Gemcitabine Neoplasms by Histologic Type Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Camptothecin Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Carcinoma, Renal Cell Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |