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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

Phase 2
18 Years
Not Enrolling
Gastric Cancer, Gastric Adenocarcinoma, Esophageal Cancer

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Trial Information

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

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

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.

Inclusion Criteria

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With One-year Recurrence-free Survival

Outcome Description:

This is defined as the patients who did not have recurrence of cancer at 1 year since the start of induction chemotherapy.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Franco Muggia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University School of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

September 2012

Related Keywords:

  • Gastric Cancer
  • Gastric Adenocarcinoma
  • Esophageal Cancer
  • gastric cancer
  • gastroesophageal junction
  • stomach cancer
  • intraperitoneal infusion
  • capecitabine
  • irinotecan
  • cisplatin
  • floxuridine
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



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