S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
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|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|
|Actual Primary Completion Date :||April 2006|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|