Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176280
Status:
WITHDRAWN
Last Update Posted:
2015-06-18
First Post:
2005-09-09
Brief Title:
Randomized Phase 2 Trial of Pre-chemotherapy Leukine vs Leukine-Dexamethasone in Combination With Gemzar 5-FU in Patients With Metastatic Renal Cell Carcinoma
Sponsor:
University of Kentucky
Organization:
University of Kentucky
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 10 gm2 intravenously infused in the veinover 30 minutes on Days 7 and 21 Folinic acid 200 mgm2 on Days 7-8 and 21-22 then 5-FU 400 mgm2 intravenously infused in the vein over 30 minutes followed by 5-FU 600 mgm2 intravenously infused in the vein over 24 hours
Study drugs
Cohort 1 Leukine 250 ugm2 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 ugm2 daily 8 am subcutaneously under the skinon 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
-Chemotherapy gemcitabine 10 gm2 intravenously infused in the veinover 30 minutes on Days 7 and 21 Folinic acid 200 mgm2 on Days 7-8 and 21-22 then 5-FU 400 mgm2 intravenously infused in the vein over 30 minutes followed by 5-FU 600 mgm2 intravenously infused in the vein over 24 hours
Study drugs
Cohort 1 Leukine 250 ugm2 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 ugm2 daily 8 am subcutaneously under the skinon 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 100000 mm3 and serum creatinine and bilirubin 15 mgdl
Chemotherapy Cohorts 1 and 2 Days 7 and 21 gemcitabine 10 gm2 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 ugm2 daily 8 am subcutaneously days 1 2 3 4 5 and 15 16 17 18 and 19
Cohort 2 Leukine 250 ugm2 daily 8 am subcutaneously days 1 2 3 45 and 15 16 17 18 and 19 and dexamethasone 12 mg every 12 hours 8 am and 8 pm orally days 3 4 56 7 17 18 19 20 and 21
Evaluations during this trial Baseline history and physical examination with vital signsweight estimation of performance status PS CAT scans of chest abdomen and pelvis EKG CBCdifferential urinalysis complete biochemistry profile CMP 12 component and quality of life assessment Prior to each course interim history physical examination with vital signsweight grading of all toxicities and estimation of PS CMP and CBCdifferential 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 CBCdifferential 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
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 100000 mm3 and serum creatinine and bilirubin 15 mgdl
Chemotherapy Cohorts 1 and 2 Days 7 and 21 gemcitabine 10 gm2 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 ugm2 daily 8 am subcutaneously days 1 2 3 4 5 and 15 16 17 18 and 19
Cohort 2 Leukine 250 ugm2 daily 8 am subcutaneously days 1 2 3 45 and 15 16 17 18 and 19 and dexamethasone 12 mg every 12 hours 8 am and 8 pm orally days 3 4 56 7 17 18 19 20 and 21
Evaluations during this trial Baseline history and physical examination with vital signsweight estimation of performance status PS CAT scans of chest abdomen and pelvis EKG CBCdifferential urinalysis complete biochemistry profile CMP 12 component and quality of life assessment Prior to each course interim history physical examination with vital signsweight grading of all toxicities and estimation of PS CMP and CBCdifferential 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 CBCdifferential 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None