Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305734
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2006-03-21
Brief Title:
Bortezomib and Gemcitabine in Treating Patients With Recurrent or Metastatic Nasopharyngeal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of PS-341 Bortezomib NSC-681239 Followed by the Addition of Gemcitabine at Progression in Recurrent or Metastatic Nasopharyngeal Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-01
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 phase II trial is studying how well giving bortezomib together with gemcitabine works in treating patients with recurrent or metastatic nasopharyngeal cancer Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as gemcitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving bortezomib together with gemcitabine may kill more tumor cells
Detailed Description:
OBJECTIVES Primary I Assess the response probability confirmed and unconfirmed complete and partial responses and 3-month progression-free survival rate in patients with metastatic or recurrent nasopharyngeal carcinoma NPC who are treated with bortezomib
Secondary I Estimate 1-year progression-free survival and assess quantitative toxicities in this group of patients treated with bortezomib
II Evaluate the response probability confirmed and unconfirmed complete and partial in the subset of patients who progress on bortezomib with measurable disease at the time of progression and go on to receive bortezomib and gemcitabine hydrochloride combination therapy
III Estimate 1-year overall survival of all patients treated with this regimen
IV Estimate 6-month progression-free survival from the start of combination therapy and assess quantitative toxicities in the subset of patients who progress on bortezomib and receive combination therapy
V Explore in a preliminary manner the relationship between changes in Epstein-Barr virus DNA level NF-kB DNA-binding activity and methylation status of E-cadherin promoter with clinical outcomes
OUTLINE This is a multicenter study of bortezomib
Patients receive bortezomib IV on days 1 4 8 and 11 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 additional courses of treatment with bortezomib
Patients who experience disease progression on single-agent bortezomib and did not receive prior gemcitabine hydrochloride may begin combination therapy within 10-28 days of the last dose of bortezomib Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and bortezomib IV on days 1 4 8 11 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a CR receive 2 additional courses beyond the confirmed CR
After the completion of study treatment patients are followed periodically for up to 3 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Secondary I Estimate 1-year progression-free survival and assess quantitative toxicities in this group of patients treated with bortezomib
II Evaluate the response probability confirmed and unconfirmed complete and partial in the subset of patients who progress on bortezomib with measurable disease at the time of progression and go on to receive bortezomib and gemcitabine hydrochloride combination therapy
III Estimate 1-year overall survival of all patients treated with this regimen
IV Estimate 6-month progression-free survival from the start of combination therapy and assess quantitative toxicities in the subset of patients who progress on bortezomib and receive combination therapy
V Explore in a preliminary manner the relationship between changes in Epstein-Barr virus DNA level NF-kB DNA-binding activity and methylation status of E-cadherin promoter with clinical outcomes
OUTLINE This is a multicenter study of bortezomib
Patients receive bortezomib IV on days 1 4 8 and 11 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 2 additional courses of treatment with bortezomib
Patients who experience disease progression on single-agent bortezomib and did not receive prior gemcitabine hydrochloride may begin combination therapy within 10-28 days of the last dose of bortezomib Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and bortezomib IV on days 1 4 8 11 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a CR receive 2 additional courses beyond the confirmed CR
After the completion of study treatment patients are followed periodically for up to 3 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000462635 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| SWOG-S0506 | None | None | None |
| U10CA032102 | NIH | None | None |