Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256269
Status:
TERMINATED
Last Update Posted:
2018-01-26
First Post:
2005-11-17
Brief Title:
Oxaliplatin and Irinotecan in Recurrent or Metastatic Esophageal and Gastroesophageal GE Junction Carcinoma
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
A Phase II Study of Weekly Oxaliplatin and Irinotecan in the Treatment of Recurrent or Metastatic Esophageal Carcinoma and Carcinoma of the Gastroesophageal GE Junction
Status:
TERMINATED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated by funding entity
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The combination of cisplatin and irinotecan has significant anti-tumor activity in esophageal cancer Oxaliplatin has been shown to have activity in combination with 5-Fluorouracil 5FU and radiation in treatment of locally advanced esophageal cancer Oxaliplatin also has better side effects profile than cisplatin and may be able to overcome tumors that have developed cisplatin resistance The standard treatment of locally advanced esophageal cancer has been cisplatin 5FU and radiation followed by possible esophagectomy However a large portion of these patients will relapse and the tumor may develop resistance to cisplatin andor the cumulative toxicity from previous treatment forbids the use of cisplatin again Weekly combination of oxaliplatin and irinotecan has been shown to be active and well tolerated in elderly population with refractory colorectal cancer Therefore we propose this phase II trial of a weekly oxaliplatin and irinotecan to test the effectiveness and the tolerability of this regimen in metastatic andor recurrent esophageal cancer
Detailed Description:
Esophageal cancer represents the seventh cause of cancer death in American men and more than 90 of patients diagnosed with esophageal cancer will ultimately die of their disease In the United States 13900 new cases of esophageal cancer and 13000 deaths from esophageal cancer are anticipated in 2003 Jemal et al 2003 The lifetime risk of esophageal cancer is 08 for men and 03 for women Ries et al 2002 The risk increases with age with a mean age at diagnosis of 67 years Ries et al 2002 Daly et al 2000 Adenocarcinoma of the esophagus or gastroesophageal junction a previously rare disease is rapidly increasing in incidence in the United States and western countries and now accounts for more than half of newly diagnosed disease Devesa et al 1998
Half of patients diagnosed with esophageal cancer present with overt metastatic disease and chemotherapy is the mainstay of palliation in this setting In patients who present initially with locoregional disease the majority will eventually develop metastatic disease as well with or without local recurrence of disease Metastatic esophageal carcinoma is an incurable disease with median survival duration of 4 to 8 months Combination chemotherapy most often cisplatin-based results in partial responses in 25 to 50 of patients with metastatic disease and rare complete responses including a 35 response rate reported for the commonly used combination of cisplatin and fluorouracil Ilson et al 1996 Recent chemotherapy trials indicate an overlap in response rates for metastatic adenocarcinoma and squamous carcinoma carcinoma of the esophagus Ilson et al 1997 Responses to chemotherapy are generally short-lived and toxicity of cisplatin-based chemotherapy particularly in the palliation of metastatic disease is often substantial and underscores the need to identify new agents in the treatment of esophageal carcinoma
Half of patients diagnosed with esophageal cancer present with overt metastatic disease and chemotherapy is the mainstay of palliation in this setting In patients who present initially with locoregional disease the majority will eventually develop metastatic disease as well with or without local recurrence of disease Metastatic esophageal carcinoma is an incurable disease with median survival duration of 4 to 8 months Combination chemotherapy most often cisplatin-based results in partial responses in 25 to 50 of patients with metastatic disease and rare complete responses including a 35 response rate reported for the commonly used combination of cisplatin and fluorouracil Ilson et al 1996 Recent chemotherapy trials indicate an overlap in response rates for metastatic adenocarcinoma and squamous carcinoma carcinoma of the esophagus Ilson et al 1997 Responses to chemotherapy are generally short-lived and toxicity of cisplatin-based chemotherapy particularly in the palliation of metastatic disease is often substantial and underscores the need to identify new agents in the treatment of esophageal carcinoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-3849 | OTHER | University of California Irvine | None |