Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039442
Status:
COMPLETED
Last Update Posted:
2017-08-24
First Post:
2002-06-06
Brief Title:
Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Evaluation Of Capecitabine NSC 712807 In The Treatment Of Persistent Or Recurrent Non-Squamous Cell Carcinoma Of The Cervix
Status:
COMPLETED
Status Verified Date:
2017-08
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:
Phase II trial to study the effectiveness of capecitabine in treating patients who have persistent or recurrent cervical cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I Determine the antitumor activity of capecitabine in patients with persistent or recurrent non-squamous cell carcinoma of the cervix who have failed higher priority treatment protocols
II Determine the nature and degree of toxicity of this drug in these patients III Determine whether the mRNA tumor expression levels of thymidylate synthase TS dihydropyrimidine dehydrogenase DPD and thymidine phosphorylase TP at baseline are potential predictors of clinical outcomes response and survival in patients treated with this drug
IV Determine whether the serum level of TP is a potential prognostic indicator of clinical outcomes response and survival in patients treated with this drug
V Determine whether the TS promoter polymorphism in peripheral blood is a potential prognostic indicator of clinical outcomes response and survival in patients treated with this drug
VI Determine the associations among the various measures of TS DPD and TP and clinical outcomes response and survival in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I Determine the antitumor activity of capecitabine in patients with persistent or recurrent non-squamous cell carcinoma of the cervix who have failed higher priority treatment protocols
II Determine the nature and degree of toxicity of this drug in these patients III Determine whether the mRNA tumor expression levels of thymidylate synthase TS dihydropyrimidine dehydrogenase DPD and thymidine phosphorylase TP at baseline are potential predictors of clinical outcomes response and survival in patients treated with this drug
IV Determine whether the serum level of TP is a potential prognostic indicator of clinical outcomes response and survival in patients treated with this drug
V Determine whether the TS promoter polymorphism in peripheral blood is a potential prognostic indicator of clinical outcomes response and survival in patients treated with this drug
VI Determine the associations among the various measures of TS DPD and TP and clinical outcomes response and survival in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-02469 | REGISTRY | None | None |
| CDR0000069384 | None | None | None |
| GOG-0128G | OTHER | None | None |
| GOG-0128G | OTHER | None | None |