Irinotecan/Cisplatin, Potentially Curative Surgery With or Without Floxuridine, Followed by Capecitabine for Stomach and Gastro-esophageal Junction (GEJ) Cancers

December 5, 2017 updated by: NYU Langone Health

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

This study is to determine whether intraperitoneal (IP) Floxuridine is effective in the patients with advanced stomach or gastro-esophageal junction cancers in the treatment consisting of pre- and post-surgery chemotherapies.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

A previous Phase-II trial conducted by the same principle investigator(s), utilizing preoperative chemotherapy and intraperitoneal 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 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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Norris Cancer Center
    • New York
      • New York, New York, United States, 10016
        • Bellevue Hospital
      • New York, New York, United States, 10016
        • NYU Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Only untreated patients with histologically documented gastric/GEJ adenocarcinoma, clinical American Joint Committee on Cancer (AJCC) stage grouping (11) IB-IV (Mo) by CT scan and laparoscopy/endoscopic ultrasound, are eligible. Excluded are patients in need of urgent surgery for gastro-intestinal obstruction, perforation or hemorrhage.
  • Both men and women >= 18 years of age with Eastern Cooperative Oncology Group (ECOG) performance status 0-2, members of any ethnic group and minorities.
  • Patients without another invasive malignancy, with adequately treated basal cell or squamous cell skin cancer, free for 5 years or more of in-situ cervix cancer or other in-situ cancer.
  • Since immune deficiency increases the risk of terminal infections when aggravated by bone marrow suppressive therapy, patients must be without active or uncontrolled infection including HIV.
  • Patients without psychiatric disorders that may interfere with their consent and/or with protocol follow-up.
  • An adequate bone-marrow reserve (absolute neutrophil count >= 1,500/ mmL, thrombocytes >= 100,000 mmL, hemoglobin >= 9 gm/dL).
  • Preserved liver and renal function (total serum bilirubin <2 mg/dL, SGOT/SGPT =< 3x the upper limit of normal, alkaline phosphatase =< 3x the upper limit of normal, blood urea nitrogen (BUN) =< 30 mg/dL, serum creatinine concentration <1.5 mg/dL and creatinine clearance >= 50 mL/min) are required. Creatinine clearance should be normalized for 1.73 M^2 BSA. The prothrombin time, activated partial thromboplastin time, and thrombin time should be within the range of normal values.
  • Since chemotherapeutic agents to be used are known or suspected to be teratogenic or with other adverse effects, women must not be pregnant or breast-feeding. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. All patients of reproductive age may not participate unless they agree to use an effective medically acceptable contraceptive method.
  • Patients without diagnosed Gilbert's disease and bilirubin level >= 2.0 mg/dL, as these patients may have excessive CPT-11 toxicity.
  • No prior severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil. Capecitabine (Xeloda) is contraindicated in patients with severe renal impairment, i.e., creatinine clearance below 30 mL/min, determined by Cockcroft-Gault equation shown on page 15 under (i) Renal impairment. In patients with moderate renal impairment (creatinine clearance 30-50 mL/min), which develops during the course of adjuvant treatment with Capecitabine, the drug is decreased to 75% of the starting dose.
  • Patients should be without any severe concurrent disease, such as cardiac condition not responding to medication, myocardial infarction within the last 12 months, active infection or uncontrolled pulmonary disease, or any other disease which in judgment of the investigator would make the patient inappropriate for entry into this study.
  • Patients who signed written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A-with IP Floxuridine

  1. Induction treatment:

    Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.

  2. Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.
  3. Randomization
  4. Surgery.

  5. Postoperative IP treatment:

    Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once

  6. Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral
Drug: Cisplatin
Drug: Capecitabine
Other Names:
  • Xeloda
Procedure: Surgery
Drug: Irinotecan
Other Names:
  • CPT-11
Drug: Floxuridine
Other Names:
  • FUDR
Experimental: B-Without IP Floxuridine
Same as Arm A except no postoperative IP treatment.
Drug: Cisplatin
Drug: Capecitabine
Other Names:
  • Xeloda
Procedure: Surgery
Drug: Irinotecan
Other Names:
  • CPT-11

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With One-year Recurrence-free Survival
Time Frame: 1 year
This is defined as the patients who did not have recurrence of cancer at 1 year since the start of induction chemotherapy.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival Rate; Toxicity; Evaluation of Sites of Relapse of Failing Patients
Time Frame: every 4 months for the first 2 years, every 6 months for years 3 and 4, then every 12 months for up to 10 years
Secondary outcome measure was not analyzed as study was terminated
every 4 months for the first 2 years, every 6 months for years 3 and 4, then every 12 months for up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

February 19, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (Estimate)

February 20, 2009

Study Record Updates

Last Update Posted (Actual)

January 8, 2018

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-837
  • NYU 05-20 (Other Identifier: NYU medical center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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