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| Sponsors and Collaborators: |
University of Kentucky Bayer |
|---|---|
| Information provided by: | University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT00176280 |
Purpose
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 |
|---|---|---|
|
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:
Prior to course 3, 5, and thereafter (every other course): CAT scans of chest, abdomen, and pelvis, tumor response and quality of life assessment. Each week after initiation of study (ie day1, course 1): CBC/differential, x 3 (Monday Wednesday and Friday). Biologic studies to include assessment of dendritic cell number and function (20 ml blood), days 1 and 7 of course 1.
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 |
|
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 |