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| Sponsor: | University of Kentucky |
|---|---|
| Collaborator: |
Bayer |
| Information provided by: | University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT00176280 |
Purpose
-Overall study design: 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).
-Chemotherapy: 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 |
|---|---|---|
|
Renal Cell Carcinoma |
Drug: Leukine Drug: Dexamethasone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 |
|
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 |