Ignite Creation Date:
2024-05-05 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 9:43 AM
Study NCT ID:
NCT00603915
Status:
COMPLETED
Last Update Posted:
2019-02-28
First Post:
2008-01-17
Brief Title:
A Study of Gemcitabine and CisplatinCarboplatin Plus Erlotinib in Patients With Nasopharyngeal Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Phase II Trial of Gemcitabine and CisplatinCarboplatin GC Plus Erlotinib in Patients With Recurrent andor Metastatic Nasopharyngeal Cancer
Status:
COMPLETED
Status Verified Date:
2019-02
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:
Cisplatin or Carboplatin will be given on day 1 every 21 days for 6 cycles Gemcitabine will be given on day 1 and day 8 every 21 days for 6 cycles Those patients that do not progress on GC after 6 cycles of chemotherapy will be started on erlotinib daily until disease progression A cycle of erlotinib will be 28 days Patients who progress on GC will be offered erlotinib as wellin order to evaluate its activity as a single-agent in the second-line setting
Patients previously treated with GC have reported a progression-free survival PFS of 9 months We would anticipate an extension of PFS to 12 months in patients treated with GC followed by maintenance erlotinib Furthermore we hypothesize that patients who achieved benefit from GC therapy would have further response when treated with maintenance erlotinib such that this strategy may increase the likelihood of attaining long-term survival
Patients previously treated with GC have reported a progression-free survival PFS of 9 months We would anticipate an extension of PFS to 12 months in patients treated with GC followed by maintenance erlotinib Furthermore we hypothesize that patients who achieved benefit from GC therapy would have further response when treated with maintenance erlotinib such that this strategy may increase the likelihood of attaining long-term survival
Detailed Description:
None
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 |
|---|---|---|---|
| NPC-774 | None | None | None |