Adjuvant Intraperitoneal Floxuridine Added to Chemoradiation for Fully Resected Advanced Stomach Cancer

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the efficacy and safety of addition of intraperitoneal (ip) Floxuridine to adjuvant chemoradiation therapy for patients under-going potentially curative stomach resection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: Food and Drug Administration (FDA)
• Treatments: Floxuridine

Criteria

Inclusion Criteria:

• Eligibility to the protocol is established following complete evaluation specified under 9.2 of the study protocol. This evaluation includes the diagnosis and disease stage. Untreated patients with histologically documented gastric/GEJ carcinoma stages IB-IV (Mo), become eligible.

• Patients who underwent emergency surgery for indications such as gastrointestinal obstruction, perforation or hemorrhage, or patients with surgery already performed, are eligible as long as the surgery is considered curative (Ro) as specified in section 9.3 of the study protocol.

• A device for adjuvant ip chemotherapy has to be in situ, placed during the surgery or early (1-3 weeks) thereafter. Time elapsed since the surgery must not exceed 4 weeks.

• Patient's diagnosis and staging, based on postoperative pathological findings, has to confirm stage IB-IV Mo adenocarcinoma of the stomach or GEJ. Patients and their clinical records must be evaluated by protocol surgical, radiation and medical oncologists, and sections of resected primary tumor and lymph nodes by protocol surgical pathologist.

• Each patient has to undergo pretreatment evaluation, sign Informed Consent, and be registered.

• Patients at least 18 years of age with performance status 0-2 (Appendix B of the study protocol).

• An adequate bone-marrow reserve (segmented neutrophils and bands, at least 1,500/ mmL, thrombocytes at least 100,000 /mmL, hemoglobin at least 9 gm/dL).

• Preserved liver and renal function (total serum bilirubin <2 mg/dL, SGOT/SGPT not greater than 2.5x the upper limit of normal, alkaline phosphatase not greater than 2.5x the upper limit of normal, BUN not greater than 30 mg/dL, creatinine concentration not greater than 1.5 mg/dL or creatinine clearance >60 mL/min), and negative BHcG in females of reproductive potential, are required.

• Patient must have evidence of at least unilateral renal function as established by CT scan with contrast or nephrogram. If only one kidney is present, at least two thirds of the functioning kidney must be excluded from any radiation port.

• The prothrombin time, activated partial thromboplastin time, and thrombin time should be within the range of normal values.

• All patients and records must be evaluated by a Surgical, Radiation and Medical Oncologists within one month before their entry to this protocol. There should be a reasonable assurance that patient will be available for planned post-treatment follow-up.

• Each patient must sign the Informed Consent Form.

Exclusion Criteria:

• Patients who do not meet criteria specified in inclusion criteria, and patients who have received prior RT, chemotherapy or immunotherapy.

• Patients with another active invasive malignancy. Adequately treated basal cell or squamous cell skin cancer, in-situ cervix cancer, or other cancers the patient has been free for at least 5 years, are acceptable.

• Patients with active or uncontrolled infection including HIV.

• Patients with psychiatric disorders that would interfere with their consent.

• Pregnant and nursing patients. Patients of reproductive age may not participate unless they agree to use an effective contraceptive method.

• Patients with any other severe concurrent disease, which in judgment of protocol investigators would make the patient inappropriate for this study.

• Protocol patients who did not receive ip FUDR treatment for complications related to catheter insertion or maintenance. However, these patients may still undergo off-protocol chemoradiation.

• Patients who did not sign written informed consent.