Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003137
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
1999-11-01
Brief Title:
Irinotecan in Treating Patients With Advanced Cancer of the Stomach
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial of CPT-11 in Patients With Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Incorporating Pretreatment and Posttreatment Biopsies for Evaluation of Tumor Thymidylate Synthase MIB-1 Topoisomerase I and p53
Status:
COMPLETED
Status Verified Date:
2016-07
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 irinotecan in treating patients who have advanced cancer of the stomach
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have advanced cancer of the stomach
Detailed Description:
OBJECTIVES I Evaluate the response rate survival and toxicity of previously untreated patients with locally advanced or metastatic gastric cancer who are treated with irinotecan CPT-11
OUTLINE This is a nonrandomized study Patients receive irinotecan CPT-11 by IV over 90 minutes every 3 weeks Dosage modifications are made based on toxicity Retreatment may be delayed another 3 weeks for a total of 6 weeks to allow for recovery from toxic effects Patient is taken off study if they do not recover from toxic effects unless cause is documented to be unrelated to CPT-11 Patients with stable disease or partial response continue on treatment until disease progression or intolerable toxicity Patients with complete response continue on treatment for another 2 courses and then are observed Patients are followed every 3 months for 3 years or until disease progression
OUTLINE This is a nonrandomized study Patients receive irinotecan CPT-11 by IV over 90 minutes every 3 weeks Dosage modifications are made based on toxicity Retreatment may be delayed another 3 weeks for a total of 6 weeks to allow for recovery from toxic effects Patient is taken off study if they do not recover from toxic effects unless cause is documented to be unrelated to CPT-11 Patients with stable disease or partial response continue on treatment until disease progression or intolerable toxicity Patients with complete response continue on treatment for another 2 courses and then are observed Patients are followed every 3 months for 3 years or until disease progression
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 |
|---|---|---|---|
| CDR0000065905 | REGISTRY | PDQ Physician Data Query | None |