Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer
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|ClinicalTrials.gov Identifier: NCT00004103|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 6, 2011
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 and combining chemotherapy with surgery may kill more tumor cells.
PURPOSE: This phase II trial is studying how well irinotecan and cisplatin followed by surgery, floxuridine, and cisplatin work in treating patients with stomach cancer.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: cisplatin Drug: floxuridine Drug: irinotecan hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy||Phase 2|
- Determine the complete and partial response rates and time to treatment failure in patients with advanced gastric cancer treated with neoadjuvant irinotecan and cisplatin followed by surgery then intraperitoneal floxuridine and cisplatin.
- Determine the rate of potentially curative surgery in patients receiving this regimen.
- Determine the toxicity and tolerance of this regimen in these patients.
OUTLINE: Patients receive cisplatin IV and irinotecan IV once a week for 4 weeks. This course is repeated 2 weeks later.
Patients who achieve complete or partial remission or stable disease undergo resection 4 weeks after the last chemotherapy dose.
Patients with no residual macroscopic disease begin adjuvant intraperitoneal (IP) chemotherapy 1 week after surgery. Chemotherapy consists of floxuridine IP over 30 minutes on days 1-3 and days 22-24 and cisplatin IP on days 3 and 24.
PROJECTED ACCRUAL: A total of 18-33 patients will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Study of Systemic Therapy With CPT-11 (Camptosar HCl) and Cisplatin in Patients With Advanced Gastric Cancer to be Followed by Surgical Resection and Postoperative Intraperitoneal Chemotherapy|
|Study Start Date :||July 1998|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||June 2009|
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): NCT00004103
|United States, New York|
|NYU Cancer Institute at New York University Medical Center|
|New York, New York, United States, 10016|
|Study Chair:||Elliot Newman, MD||New York University School of Medicine|