Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003192
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
1999-11-01
Brief Title:
Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase II Trial of 9-Aminocamptothecin NSC 603071 Administered as a 120-Hour Continuous Infusion in Patients With Previously Untreated Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2013-09
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
PURPOSE Phase II trial to study the effectiveness of aminocamptothecin in treating patients with locally advanced metastatic or recurrent cancer of the stomach or esophagus
PURPOSE Phase II trial to study the effectiveness of aminocamptothecin in treating patients with locally advanced metastatic or recurrent cancer of the stomach or esophagus
Detailed Description:
OBJECTIVES I Determine the objective response rate of a 120 hour continuous infusion of aminocamptothecin 9-AC in chemotherapy naive patients with adenocarcinoma of the stomach or gastroesophageal junction II Characterize the nature of the toxicity of 9-AC on this schedule in this patient population III Determine the duration of response time to progression and survival of this patient population IV Study the pharmacokinetics and pharmacodynamics of 9-AC on this schedule in these patients
OUTLINE This is an open label multicenter study Patients receive intravenous aminocamptothecin by continuous infusion over 120 hours on days 1-5 and 8-12 followed by 1 week of rest for a 3 week cycle Therapy continues for a minimum of 6 weeks 2 full cycles unless there are unacceptable toxic effects or rapid disease progression Dose escalation may occur in patients who complete 3 cycles of therapy without unacceptable toxicity All patients will be followed for survival
PROJECTED ACCRUAL This study will accrue 14-40 patients within 18 months
OUTLINE This is an open label multicenter study Patients receive intravenous aminocamptothecin by continuous infusion over 120 hours on days 1-5 and 8-12 followed by 1 week of rest for a 3 week cycle Therapy continues for a minimum of 6 weeks 2 full cycles unless there are unacceptable toxic effects or rapid disease progression Dose escalation may occur in patients who complete 3 cycles of therapy without unacceptable toxicity All patients will be followed for survival
PROJECTED ACCRUAL This study will accrue 14-40 patients within 18 months
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-T97-0013 | None | None | None |
| UCCRC-9025 | None | None | None |