Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004257
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
2000-01-28
Brief Title:
Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer
Sponsor:
Albany Medical College
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Oxaliplatin in Combination With Continuous Infusion 5-Fluorouracil and Radiation in Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2007-12
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 use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining oxaliplatin and fluorouracil plus radiation therapy in treating patients who have primary esophageal or stomach cancer
PURPOSE Phase I trial to study the effectiveness of combining oxaliplatin and fluorouracil plus radiation therapy in treating patients who have primary esophageal or stomach cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose-limiting toxicity of oxaliplatin when given in combination with continuous-infusion fluorouracil and radiotherapy in patients with primary cancer of the thoracic esophagus or gastroesophageal junction
Determine the pharmacokinetics of this regimen in this patient population
Assess somatic p53 mutations in cancer of the esophagus and determine their relation to therapeutic response induced by this regimen
Assess in a preliminary manner the efficacy of this regimen in these patients
OUTLINE This is a dose-escalation study of oxaliplatin and fluorouracil
Patients receive oxaliplatin IV over 2 hours on days 1 15 and 29 and fluorouracil IV continuously on days 8-42 Patients also undergo radiotherapy once daily 5 days a week for 6 weeks beginning on day 8
Patients without evidence of distant disease or unresectable local regional invasion undergo esophageal resection between days 63-70 within 3-4 weeks after completion of chemoradiotherapy Patients then receive oxaliplatin as above on days 105 119 and 133 and fluorouracil as above on days 105-147
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil until the maximum tolerated dose MTD 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
Patients are followed every 4 weeks
PROJECTED ACCRUAL A total of 56 patients will be accrued for this study within approximately 3 years
Determine the maximum tolerated dose and dose-limiting toxicity of oxaliplatin when given in combination with continuous-infusion fluorouracil and radiotherapy in patients with primary cancer of the thoracic esophagus or gastroesophageal junction
Determine the pharmacokinetics of this regimen in this patient population
Assess somatic p53 mutations in cancer of the esophagus and determine their relation to therapeutic response induced by this regimen
Assess in a preliminary manner the efficacy of this regimen in these patients
OUTLINE This is a dose-escalation study of oxaliplatin and fluorouracil
Patients receive oxaliplatin IV over 2 hours on days 1 15 and 29 and fluorouracil IV continuously on days 8-42 Patients also undergo radiotherapy once daily 5 days a week for 6 weeks beginning on day 8
Patients without evidence of distant disease or unresectable local regional invasion undergo esophageal resection between days 63-70 within 3-4 weeks after completion of chemoradiotherapy Patients then receive oxaliplatin as above on days 105 119 and 133 and fluorouracil as above on days 105-147
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil until the maximum tolerated dose MTD 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
Patients are followed every 4 weeks
PROJECTED ACCRUAL A total of 56 patients will be accrued for this study within approximately 3 years
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 |
|---|---|---|---|
| NCI-T99-0061 | None | None | None |
| ALB-RPCI-DS-99-08 | None | None | None |
| RPCI-DS-99-08 | None | None | None |