NCT00176280

Randomized Phase 2 Trial of Pre-chemotherapy Leukine vs. Leukine-Dexamethasone in Combination With Gemzar & 5-FU in Patients With Metastatic Renal Cell Carcinoma

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)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Kentucky · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

-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: * Cohort 1, Leukine, 250 ug/m2 daily (8 am) subcutaneously (under the skin) on days 1, 2, 3, 4, 5 and 15, 16, 17, 18, and 19; * Cohort 2, Leukine, 250 ug/m2 daily (8 am) subcutaneously (under the skin)on days 1, 2, 3, 4, 5, and 15, 16, 17, 18, and 19 and dexamethasone 12 mg every 12 hours (8 am and 8 pm) orally (by mouth) on days 3, 4, 5, 6, 7, 17, 18, 19, 20, and 21.

Detailed description

STUDY SYNOPSIS Objectives: Primary: 1. Determine the response rates and overall survival in patients with metastatic renal cell carcinoma (RCC) receiving pre-treatment with Leukine-dexamethasone vs Leukine alone in combination with gemcitabine-5-FU. 2. Determine if pre-treatment with the combination of Leukine-dexamethasone is more effective than pre-treatment with Leukine alone in reducing the hematopoietic and non-hematopoietic toxicities of gemcitabine-5-FU in patients with metastatic RCC. Secondary: 1. Determine the effects of the combination of Leukine-dexamethasone vs Leukine alone on the number and function of peripheral blood dendritic cells, and cytokine levels when given prior to gemcitabine-5-FU in patients with metastatic RCC. 2. Determine quality of life and toxicity of treatment in patients with metastatic RCC receiving pre-treatment with Leukine-dexamethasone vs Leukine alone in combination with gemcitabine-5-FU. 3. Determine the dose intensity administered in both treatment groups. Study Design: * Overall study design: A randomized Phase II study in patients with metastatic RCC Patients will receive chemotherapy with gemcitabine-5-FU. Patients will receive prior to each chemotherapy the combination of Leukine alone (Cohort 1) or Leukine-dexamethasone (Cohort 2). * Patient eligibility: a) chemotherapy naive patients with biopsy proven RCC, b) PS (ECOG), 0, 1, or 2, c) measurable disease by RECIST criteria, d) previous immunotherapy and anti-angiogenic therapy is allowed, e) adequate bone marrow, renal and hepatic function as defined by AGC \> 1500 and PLC \> 100,000 mm3 and serum creatinine and bilirubin \< 1.5 mg/dl. * Chemotherapy: Cohorts 1 and 2: Days 7 and 21: gemcitabine 1.0 g/m2 intravenously over 30 minutes; Days 7-8 and 21-22: Folinic acid 200 mg/ m2, then 5-FU 400 mg/ m2, intravenously over 30 minutes followed by 5-FU 600 mg/ m2 intravenously over 24 hours. * Study Drugs: * Cohort 1, Leukine, 250 ug/m2 daily (8 am) subcutaneously days 1, 2, 3, 4, 5, and 15, 16, 17, 18, and 19; * Cohort 2, Leukine, 250 ug/m2 daily (8 am) subcutaneously days 1, 2, 3, 4,5, and 15, 16, 17, 18, and 19 and dexamethasone 12 mg every 12 hours (8 am and 8 pm) orally days 3, 4, 5,6, 7, 17, 18, 19, 20, and 21. * Evaluations during this trial: Baseline: history and physical examination with vital signs/weight, estimation of performance status (PS), CAT scans of chest, abdomen and pelvis, EKG, CBC/differential, urinalysis, complete biochemistry profile (CMP) (12 component) and quality of life assessment. Prior to each course: interim history, physical examination with vital signs/weight, grading of all toxicities, and estimation of PS, CMP, and CBC/differential. 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.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Leukine
DRUG	Dexamethasone

Timeline

• Start date: 2005-09-01
• First posted: 2005-09-15
• Last updated: 2015-06-18