NCT00003137

Irinotecan in Treating Patients With Advanced Cancer of the Stomach

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Esophageal Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	irinotecan hydrochloride

Timeline

• Start date: 1997-12-01
• Primary completion: 2004-07-01
• Completion: 2004-07-01
• First posted: 2004-01-22
• Last updated: 2016-07-14

Locations

19 sites across 2 countries: United States, Canada