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Sponsors and Collaborators: |
New York University School of Medicine National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004103 |
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 | Intervention | Phase |
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Gastric Cancer |
Drug: cisplatin Drug: floxuridine Drug: irinotecan hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven, previously untreated gastric cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, New York | |
NYU Cancer Institute at New York University Medical Center | |
New York, New York, United States, 10016 |
Study Chair: | Howard S. Hochster, MD | New York University School of Medicine |
Study ID Numbers: | CDR0000067322, NYU-9822, P-UPJOHN-647597196, NCI-G99-1594 |
Study First Received: | December 10, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004103 History of Changes |
Health Authority: | United States: Federal Government |
stage I gastric cancer stage II gastric cancer stage III gastric cancer stage IV gastric cancer |
Antimetabolites Digestive System Neoplasms Gastrointestinal Diseases Floxuridine Irinotecan Adjuvants, Immunologic Camptothecin Digestive System Diseases |
Stomach Diseases Cisplatin Radiation-Sensitizing Agents Stomach Neoplasms Gastrointestinal Neoplasms Stomach Cancer Antineoplastic Agents, Phytogenic |
Antimetabolites Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Floxuridine Antineoplastic Agents Physiological Effects of Drugs Irinotecan Enzyme Inhibitors Pharmacologic Actions |
Camptothecin Neoplasms Neoplasms by Site Digestive System Diseases Stomach Diseases Radiation-Sensitizing Agents Cisplatin Therapeutic Uses Stomach Neoplasms Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic |