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Sponsors and Collaborators: |
New York University School of Medicine Food and Drug Administration (FDA) |
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Information provided by: | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00848783 |
This study is to determine whether intraperitoneal Floxuridine is effective in the patients with advanced stomach or gastro-esophageal junction cancers in the treatment consisting of pre- and post-surgery chemotherapies.
Condition | Intervention | Phase |
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Gastric Cancer Gastroesophageal Adenocarcinoma Gastric Adenocarcinoma |
Drug: Cisplatin+Irinotecan Drug: Floxuridine Drug: Capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase-II Study of Patients With Locally Advanced Gastric of Gastro-Esophageal Adenocarcinoma Treated With Induction Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Adjuvant Intraperitoneal Floxuridine, Followed by Prolonged Administration of Capecitabine |
Estimated Enrollment: | 62 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2015 |
Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
with Floxuridine Induction treatment: Day 1,8,15,22: Cisplatin 25 mg/M2/week; Day 1,8,15,22: Irinotecan 75 mg/M2/week, both intravenous; Two weeks without treatment; Repeat the course with or without cisplatin/Irinotecan dose modification. If clinical PD, re-evaluation, and the patient may go off the protocol. Re-evaluation, surgery if CR, PR or SD, or off the protocol if PD. BEFORE SURGERY: RANDOMIZATION TO ARM A OR B Surgery. The intraperitoneal (ip) catheter for ARM A in place. Postoperative treatment starts 1-3 weeks after the surgery. Postoperative ip treatment: Day 1,2,3:Floxuridine 3 gm/day, Intraperitoneal; Day 3:Cisplatin 60 mg/M2, Intraperitoneal; 2 weeks without treatment; Day 22,23,24:Floxuridine 3 gm/day, Intraperitoneal; Day 24:Cisplatin 60 mg/M2, Intraperitoneal; 1 week without treatment. Postoperative systemic treatment: course 1-9:Capecitabine 2,000 mg/M2/day x14 q 3 weeks/course, Oral |
Drug: Cisplatin+Irinotecan
Cisplatin+Irinotecan
Drug: Floxuridine
Floxuridine
Drug: Capecitabine
Capecitabine
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B: Experimental
without Floxuridine Same as Arm A except that no postoperative IP treatment. |
Drug: Cisplatin+Irinotecan
Cisplatin+Irinotecan
Drug: Capecitabine
Capecitabine
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A previous Phase-II trial conducted by the same principle investigator(s), utilizing preoperative chemotherapy and intraperitoneal (IP) consolidation, was conducted in patients with locally advanced, potentially resectable gastric cancer or cancer of the gastro-esophageal junction (GEJ), both staged as T3N0, T4N0, any TN1 or TN2 disease. The data suggest that for patients with locally advanced gastric or GEJ cancer, systemic induction therapy, curative surgery with high Ro resection rates, and IP adjuvant therapy, has acceptable toxicity and encouraging survival outcome. The Medical Research Council Adjuvant Gastric Infusional Chemotherapy (MAGIC) trial has also shown that perioperative chemotherapy - chemotherapy given both before and after surgery - can provide a significant survival benefit.
The investigators hypothesize that adjuvant intraperitoneal(IP)salvage of cancer micrometastatic residues after surgery contributes to disease-free survival. The goal of this trial is to determine whether IP Floxuridine, added to adjuvant postoperative chemotherapy, prolongs patient's survival. This will be tested during the randomized open-label trial.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contact: Franco Muggia, MD | 212-263-6485 | franco.muggia@nyumc.org |
Contact: Minerva Utate, RN | 212-263-5926 | minerva.utate@nyumc.org |
United States, California | |
Norris Cancer Center | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Syma Iqbal, MD 323-865-3907 | |
United States, New York | |
NYU Cancer Center | Recruiting |
New York, New York, United States, 10016 | |
Bellevue Hospital | Recruiting |
New York, New York, United States, 10016 | |
Peru | |
INEN | Recruiting |
Lima, Peru | |
Contact: Jorge Chong, MD 511-620-4995 eruiz@inen.sld.pe |
Principal Investigator: | Franco Muggia, MD | New York University School of Medicine |
Responsible Party: | New York University Cancer Institute ( Franco Muggia, MD ) |
Study ID Numbers: | 07-837, NYU 05-20 |
Study First Received: | February 19, 2009 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00848783 History of Changes |
Health Authority: | United States: Food and Drug Administration |
gastric cancer gastroesophageal junction stomach cancer intraperitoneal infusion |
capecitabine irinotecan cisplatin floxuridine |
Antimetabolites Capecitabine Digestive System Neoplasms Floxuridine Gastrointestinal Diseases Irinotecan Adjuvants, Immunologic Carcinoma Digestive System Diseases Stomach Diseases |
Radiation-Sensitizing Agents Cisplatin Esophageal Disorder Stomach Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Stomach Cancer Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Irinotecan Physiological Effects of Drugs Stomach Diseases Neoplasms by Site Cisplatin Stomach Neoplasms Therapeutic Uses Capecitabine |
Digestive System Neoplasms Neoplasms by Histologic Type Floxuridine Enzyme Inhibitors Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |