NCT00012363

S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus

Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• 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. 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 esophagus.

Detailed description

OBJECTIVES: * Determine the 6-month survival rate of patients with metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction treated with gemcitabine and irinotecan. * Determine the qualitative and quantitative toxic effects of this regimen in these patients. OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study.

Conditions

• Esophageal Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride	1,000mg/m2, IV over 30 min, days 1 \& 8, q 21 days
DRUG	irinotecan hydrochloride	100 mg/m2, IV over 90 min, days 1 \& 8, q 21days

Timeline

• Start date: 2001-04-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2003-01-27
• Last updated: 2012-06-14

Locations

96 sites across 1 country: United States