Viewing Study NCT00005607



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Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00005607
Status: UNKNOWN
Last Update Posted: 2013-12-19
First Post: 2000-05-02

Brief Title: Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Cancer of the Stomach or Esophagus
Sponsor: Robert H Lurie Cancer Center
Organization: National Cancer Institute NCI

Study Overview

Official Title: A Phase II Study of CPT-11 and 5-FULCV in Patients With Previously Untreated Gastric Adenocarcinoma
Status: UNKNOWN
Status Verified Date: 2000-07
Last Known Status: ACTIVE_NOT_RECRUITING
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 Combining more than one drug may kill more tumor cells

PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or recurrent cancer of the stomach or esophagus
Detailed Description: OBJECTIVES I Determine the response rate of patients with metastatic or recurrent adenocarcinoma of the stomach or gastroesophageal junction when treated with irinotecan fluorouracil and leucovorin calcium II Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in this patient population

OUTLINE Patients receive irinotecan IV over 90 minutes leucovorin calcium IV over 15 minutes and fluorouracil IV once weekly for 4 weeks followed by 2 weeks of rest Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression Patients are followed at 30 days and then until death

PROJECTED ACCRUAL A total of 18-37 patients will be accrued for this study

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-G00-1740 None None None
NU-VCCGI9801 None None None
P-UPJOHN-976475148 None None None