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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 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
| ClinicalTrials.gov Identifier: | NCT00176280 History of Changes |
| Other Study ID Numbers: | 04-GU-51-B |
| Study First Received: | September 9, 2005 |
| Last Updated: | August 7, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
Renal Carcinoma Renal Cell Carcinoma RCC Leukine |
Dexamethasone Gemcitabine 5 Fluorouracil 5 FU Metastatic |
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate |
Gemcitabine Fluorouracil BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |