Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256295
Status:
TERMINATED
Last Update Posted:
2017-02-01
First Post:
2005-11-17
Brief Title:
Weekly Oxaliplatin and Gemcitabine for Recurrent or Metastatic Head and Neck Cancer
Sponsor:
Sai-Hong Ignatius Ou
Organization:
University of California Irvine
Study Overview
Official Title:
A Phase II Study of Weekly Oxaliplatin and Gemcitabine Combination Chemotherapy for Recurrent or Metastatic Head and Neck Cancer
Status:
TERMINATED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The combination of oxaliplatin and gemcitabine is highly active in a wide variety of tumors including pancreatic germ cell breast biliary mesothelioma Mitchell et al 2002 and lung In the last study which utilized days 1 and 8 gemcitabine 1000 mgm2 and days 1 and 8 oxaliplatin 65 mgm2 in poor prognosis lung cancer patients PS 1-3 the response rate was 16 with no incidence of febrile neutropenia
Toxicity is a crucial consideration when designing regimens intended for palliation Toxicities associated with cisplatin can make it difficult to use in patients with Head and Neck Cancer HNC many of whom are elderly and have comorbidities In addition many patients with metastatic HNC have previously received cisplatin during neoadjuvantadjuvant therapy or as part of their primary chemoradiation treatment When these patients recur it is possible their tumors have innate or acquired cisplatin resistance Oxaliplatin is likely to be better tolerated than cisplatin containing regimens especially with regards to neurotoxicity Gemcitabine has shown promising activity as a single agent and in combination chemotherapy in the first line treatment of patients with HNC A combination chemotherapy regimen using oxaliplatin and gemcitabine administered once every week is logical and worth exploring in patients with metastatic and recurrent head and neck cancer to improve the toxicity profile and patient monitoring while maintaining efficacy of the chemotherapy regimen
Toxicity is a crucial consideration when designing regimens intended for palliation Toxicities associated with cisplatin can make it difficult to use in patients with Head and Neck Cancer HNC many of whom are elderly and have comorbidities In addition many patients with metastatic HNC have previously received cisplatin during neoadjuvantadjuvant therapy or as part of their primary chemoradiation treatment When these patients recur it is possible their tumors have innate or acquired cisplatin resistance Oxaliplatin is likely to be better tolerated than cisplatin containing regimens especially with regards to neurotoxicity Gemcitabine has shown promising activity as a single agent and in combination chemotherapy in the first line treatment of patients with HNC A combination chemotherapy regimen using oxaliplatin and gemcitabine administered once every week is logical and worth exploring in patients with metastatic and recurrent head and neck cancer to improve the toxicity profile and patient monitoring while maintaining efficacy of the chemotherapy regimen
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 |
|---|---|---|---|
| 2004-3776 | OTHER | University of California Irvine | None |