Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093652
Status:
TERMINATED
Last Update Posted:
2015-10-06
First Post:
2004-10-06
Brief Title:
Oxaliplatin Gefitinib and Radiation Therapy in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
ZD1839 IRESSA With Oxaliplatin and Radiotherapy for Esophageal Carcinoma A Phase III Study With Biologic Correlates
Status:
TERMINATED
Status Verified Date:
2015-10
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:
RATIONALE Drugs used in chemotherapy such as oxaliplatin work in different ways to stop tumor cells from dividing so they stop growing or die Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Radiation therapy uses high-energy x-rays to damage tumor cells Combining oxaliplatin and gefitinib with radiation therapy may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of oxaliplatin when given together with gefitinib and radiation therapy and to see how well they work in treating patients with locally advanced or metastatic esophageal cancer
PURPOSE This phase III trial is studying the side effects and best dose of oxaliplatin when given together with gefitinib and radiation therapy and to see how well they work in treating patients with locally advanced or metastatic esophageal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of oxaliplatin when administered with gefitinib and radiotherapy in patients with locally advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction Phase I
Determine the response rate in patients treated with this regimen Phase II
Secondary
Determine time to tumor progression and median survival in patients treated with this regimen
Determine quality of life in patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE This is a phase I open-label dose-escalation study of oxaliplatin followed by a phase II study
Phase I Patients receive oxaliplatin IV over 2 hours on days 1 15 and 29 Beginning on day 1 patients undergo radiotherapy once daily 5 days a week for 55 weeks Patients also receive oral gefitinib once daily on days 1-365 Treatment continues in the absence of disease progression or unacceptable toxicity Approximately 3-6 weeks after the completion of chemoradiotherapy patients are evaluated Some patients undergo surgical resection and possibly receive a second course of oxaliplatin IV over 2 hours on days 1 15 and 29 4-8 weeks after surgery If surgery is not indicated some patients may receive an additional course of oxaliplatin
Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive oxaliplatin gefitinib and radiotherapy as in phase I at the MTD Some patients then either undergo surgical resection andor begin a second course of oxaliplatin as in phase I
NOTE Oral gefitinib is discontinued 7 days before surgery and is restarted when the patient has recovered
Quality of life is assessed at baseline 5-6 weeks and then every 2-3 months for 1 year
Patients are followed every 2-3 months for 1 year
PROJECTED ACCRUAL Approximately 15-45 patients 3-12 for phase I and 12-33 for phase II will be accrued for this study within 2 years
Primary
Determine the maximum tolerated dose of oxaliplatin when administered with gefitinib and radiotherapy in patients with locally advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction Phase I
Determine the response rate in patients treated with this regimen Phase II
Secondary
Determine time to tumor progression and median survival in patients treated with this regimen
Determine quality of life in patients treated with this regimen
Determine the safety of this regimen in these patients
OUTLINE This is a phase I open-label dose-escalation study of oxaliplatin followed by a phase II study
Phase I Patients receive oxaliplatin IV over 2 hours on days 1 15 and 29 Beginning on day 1 patients undergo radiotherapy once daily 5 days a week for 55 weeks Patients also receive oral gefitinib once daily on days 1-365 Treatment continues in the absence of disease progression or unacceptable toxicity Approximately 3-6 weeks after the completion of chemoradiotherapy patients are evaluated Some patients undergo surgical resection and possibly receive a second course of oxaliplatin IV over 2 hours on days 1 15 and 29 4-8 weeks after surgery If surgery is not indicated some patients may receive an additional course of oxaliplatin
Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive oxaliplatin gefitinib and radiotherapy as in phase I at the MTD Some patients then either undergo surgical resection andor begin a second course of oxaliplatin as in phase I
NOTE Oral gefitinib is discontinued 7 days before surgery and is restarted when the patient has recovered
Quality of life is assessed at baseline 5-6 weeks and then every 2-3 months for 1 year
Patients are followed every 2-3 months for 1 year
PROJECTED ACCRUAL Approximately 15-45 patients 3-12 for phase I and 12-33 for phase II will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ZENECA-IRUSIRES0303 | None | None | None |
| RPCI-I-04603 | None | None | None |