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Sponsors and Collaborators: |
University of Kentucky Bayer |
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Information provided by: | University of Kentucky |
ClinicalTrials.gov Identifier: | NCT00176280 |
A randomized Phase II study in patients with metastatic RCC Patients will receive chemotherapy with gemcitabine and 5-FU. Prior to each chemotherapy the patient will receive a combination of Leukine alone (study cohort 1) or Leukine-dexamethasone (study cohort 2).
gemcitabine 1.0 g/m2 intravenously (infused in the vein)over 30 minutes on Days 7 and 21, Folinic acid 200 mg/m2 on Days 7-8 and 21-22, then 5-FU 400 mg/m2, intravenously (infused in the vein) over 30 minutes followed by 5-FU 600 mg/m2 intravenously (infused in the vein) over 24 hours.
Study drugs:
Condition | Intervention | Phase |
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Renal Cell Carcinoma |
Drug: Leukine Drug: Dexamethasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Phase II Trial of Pre-Chemotherapy Leukine Vs. Leukine-Dexamethasone in Combination With Gemcitabine and 5-Fluorouracil (5-FU) in Patients With Metastatic Renal Cell Carcinoma (RCC) |
Estimated Enrollment: | 64 |
Study Start Date: | September 2005 |
STUDY SYNOPSIS
Objectives:
Primary:
Secondary:
Study Design:
Study Drugs:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients have the right to withdraw from the study at any time, without prejudice.
Exclusion Criteria:
Pregnant women are excluded from this study because of the teratogenic potential of 5-FU and gemcitabine.
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Lactating women are also excluded. Post menopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
Study ID Numbers: | 04-GU-51-B |
Study First Received: | September 9, 2005 |
Last Updated: | August 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00176280 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Renal Carcinoma Renal Cell Carcinoma RCC Leukine |
Dexamethasone Gemcitabine 5 Fluorouracil 5 FU Metastatic |
Dexamethasone Anti-Inflammatory Agents Antimetabolites Urinary Tract Neoplasm Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Urogenital Neoplasms Urologic Neoplasms Hormones Renal Cancer Urologic Diseases Kidney Neoplasms |
Kidney Diseases Gemcitabine Dexamethasone acetate Kidney Cancer Antineoplastic Agents, Hormonal Immunosuppressive Agents Glucocorticoids Carcinoma Fluorouracil Carcinoma, Renal Cell Peripheral Nervous System Agents Adenocarcinoma Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Inflammatory Agents Dexamethasone Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Urogenital Neoplasms Urologic Neoplasms Hormones Neoplasms by Site Urologic Diseases |
Kidney Neoplasms Therapeutic Uses Kidney Diseases Dexamethasone acetate Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Gastrointestinal Agents Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Carcinoma Neoplasms Autonomic Agents Fluorouracil Carcinoma, Renal Cell |