Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216138
Status:
TERMINATED
Last Update Posted:
2011-05-02
First Post:
2005-09-12
Brief Title:
Docetaxel and Capecitabine for First Line Treatment of Metastatic Squamous Cell Carcinoma of the Head Neck
Sponsor:
Hoosier Cancer Research Network
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Single Arm Phase II Trial of Docetaxel and Capecitabine for the First Line Treatment of RecurrentMetastatic Squamous Cell Carcinoma of the Head and Neck SCCHN Hoosier Oncology Group HN02-40
Status:
TERMINATED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis results did not meet criteria for second stage of trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recent progress in treatment of recurrentmetastatic SCCHN has been made with the introduction of the taxanes Docetaxel as a single agent has a response rate of 22-42 and 17 in patients with recurrent disease Capecitabine is an oral fluoropyrimidine prodrug that is converted into 5-FU Previous studies have shown that the capecitabinedocetaxel combination has a synergistic inhibition of tumor growth resulting in significantly superior efficacy in time to disease progression TTP overall survival median survival and objective tumor response rate compared to docetaxel alone
This trial will investigate the efficacy the combination of docetaxel and capecitabine in treating patients with recurrentmetastatic SCCHN
This trial will investigate the efficacy the combination of docetaxel and capecitabine in treating patients with recurrentmetastatic SCCHN
Detailed Description:
OUTLINE This is a multi-center study
Dexamethasone and antiemetic premedication1
Docetaxel 60 mgm2 for a 60 minute infusion day 1 of each cycle
Capecitabine 825 mgm2 po BID Days 1-14
Repeat every 21 days until tumor progression or toxicity that requires discontinuation of therapy
Performance status ECOG performance status 0 or 1
Life expectancy At least 3 months
Hematopoietic
ANC of 1500mm3
Platelets 100000mm3
Hemoglobin 8 gmdl
Hepatic
Total Bilirubin ULN
Albumin 3
Maximum Alk Phos 25 x 5 x ULN
Renal
Creatinine clearance of 50 ml min by Cockcroft-Gault
Cardiovascular
No decompensated congestive heart failure or active angina
Clinically significant cardiac disease not well controlled with medication eg congestive heart failure symptomatic coronary artery disease and cardiac arrhythmias or myocardial infarction in the past 12 months is not allowed
Pulmonary
Not specified
Dexamethasone and antiemetic premedication1
Docetaxel 60 mgm2 for a 60 minute infusion day 1 of each cycle
Capecitabine 825 mgm2 po BID Days 1-14
Repeat every 21 days until tumor progression or toxicity that requires discontinuation of therapy
Performance status ECOG performance status 0 or 1
Life expectancy At least 3 months
Hematopoietic
ANC of 1500mm3
Platelets 100000mm3
Hemoglobin 8 gmdl
Hepatic
Total Bilirubin ULN
Albumin 3
Maximum Alk Phos 25 x 5 x ULN
Renal
Creatinine clearance of 50 ml min by Cockcroft-Gault
Cardiovascular
No decompensated congestive heart failure or active angina
Clinically significant cardiac disease not well controlled with medication eg congestive heart failure symptomatic coronary artery disease and cardiac arrhythmias or myocardial infarction in the past 12 months is not allowed
Pulmonary
Not specified
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