S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
|ClinicalTrials.gov Identifier: NCT00012363|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 14, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Gastric Cancer||Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II|
|Study Start Date :||April 2001|
|Primary Completion Date :||April 2006|
|Study Completion Date :||April 2006|
Experimental: Gemcitabine + Irinotecan
Gemcitabine 1000mg/m2 IV over 30 min on Days 1,8 q21days; Irinotecan 100mg/m2 IV over 90 min on Days 1,8 q21days
Drug: gemcitabine hydrochloride
1,000mg/m2, IV over 30 min, days 1 & 8, q 21 days
Other Name: Gemzar (NSC-613327)Drug: irinotecan hydrochloride
100 mg/m2, IV over 90 min, days 1 & 8, q 21days
Other Name: CPT-11 (NSC-616348)
- 6-month survival rate [ Time Frame: 6 months after registration ]To assess the six-month survival rate in patients with esophageal cancer treated with a gemcitabine-irinotecan combination chemotherapy regimen.
- Toxicities [ Time Frame: Week 1 and Week 2 of each cycle ]To assess the qualitative and quantitative toxicities associated with this regimen in a Phase II study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00012363
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|Study Chair:||Stephen K. Williamson, MD||University of Kansas|