Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201825
Status:
COMPLETED
Last Update Posted:
2014-10-06
First Post:
2005-09-12
Brief Title:
A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients
Sponsor:
Tony Bekaii-Saab
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the objective response rate in chemotherapy naive non-small cell lung cancer patients with advanced disease
Detailed Description:
Rationale Docetaxel has some efficacy against non-small cell lung cancer NSCLC This drug is Food and Drug Administration approved in combination with cisplatin Platinol for the treatment of unresectable locally advanced or metastatic NSCLC in patients who have not previously had chemotherapy for this condition Docetaxel is also approved for second line treatment of metastatic NSCLC Research indicates that capecitabine in combination with docetaxel has efficacy against NSCLC Capecitabine appears to have anti-cancer activity through several enzymes This drug is metabolized in the body to another agent called 5-FU During this conversion process 5-FU requires thymidine phosphorylase TP a cellular characteristic associated with tumor growth There are higher levels of TP expression in tumors as compared to normal tissue The drug administration schedule in this study is designed to optimize efficacy against the TP target through both docetaxel and capecitabine This study will measure biological changes to TP and other enzymes to help researchers gain more information about how capecitabine and docetaxel works against NSCLC
Purpose This study will evaluate the efficacy of docetaxel and capecitabine in patients with previously untreated advanced NSCLC Tests related to tumor biology will be conducted before and during study treatments and correlated with patient responses to therapies
Treatment Patients in this study will receive docetaxel and capecitabine Docetaxel will be administered through intravenous infusions Capecitabine will be provided through oral pills A four-week period constitutes one cycle Docetaxel will be given weekly for three weeks followed by one week of rest Capecitabine will be taken twice daily on days 5 through 14 of the treatment cycle Several tests and exams will be given throughout the study to closely monitor patients Treatments will be discontinued due to disease growth or unacceptable side effects
Purpose This study will evaluate the efficacy of docetaxel and capecitabine in patients with previously untreated advanced NSCLC Tests related to tumor biology will be conducted before and during study treatments and correlated with patient responses to therapies
Treatment Patients in this study will receive docetaxel and capecitabine Docetaxel will be administered through intravenous infusions Capecitabine will be provided through oral pills A four-week period constitutes one cycle Docetaxel will be given weekly for three weeks followed by one week of rest Capecitabine will be taken twice daily on days 5 through 14 of the treatment cycle Several tests and exams will be given throughout the study to closely monitor patients Treatments will be discontinued due to disease growth or unacceptable side effects
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-03593 | REGISTRY | CTRP Clinical Trials Reporting Program | None |