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

NCT00858338 | Completed Phase 2 DMC

• 1 other identifier: 02-51 (H 10610)
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Gastric Cancer; Stomach Cancer

Keywords

stomach cancer; gastroesophageal junction cancer; GEJ cancer; intraperitoneal; adjuvant chemoradiation therapy; resection of advanced stomach cancer; locally advanced stomach cancer

Outcome Measures

Primary Outcomes (1)

• toxicity of IP FUDR after surgery prior to chemoradiation

  6 months

Secondary Outcomes (2)

• overall survival

  up to 10 years

• Time to relapse, disease specific survival

  up to 10 years

Interventions

Potentially curative surgery PROCEDURE

Surgery: Week 1: Potentially curative surgery. If the tumor successfully resected (microscopically disease-free margins, Ro, with regional lymphadenectomy for proper staging), the ip catheter in place. Weeks 2-4: Recovery. Then continue to adjuvant IP chemotherapy.

Floxuridine (IP) DRUG

Adjuvant IP Chemotherapy: week 1: ip Floxuridine 3 gm/day, days 1,2,3. week 2: 1 week without treatment. week 3: ip Floxuridine 3 gm/day protocol days 15,16,17. week 4: 1 week without treatment. Then continue to chemoradiation therapy.

Also known as: FUDR

Adjuvant Chemoradiation therapy PROCEDURE

Adjuvant Chemoradiation therapy: week 1: 5-FU 425 mg/m2/day x 5 days + Leucovorin (LV) 20 mg/m2/day x 5days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU 400 mg/m2 + LV 20 mg/m2 each day on days 1-4; week 9: 5-FU 400 mg/m2 + LV 20 mg/m2 each day on days 1-3; week 14: 5-FU 425 mg/m2/day x 5 days + Leucovorin (LV) 20 mg/m2/day x 5days; week 19: 5-FU 425 mg/m2/day x 5 days + Leucovorin (LV) 20 mg/m2/day x 5days.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (3)

Bellevue Hospital

New York, New York, 10016, United States

Location

NYU Cancer Center

New York, New York, 10016, United States

Location

NYU Tisch Hospital

New York, New York, 10016, United States

Location

Related Links

• Publication for this study

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Floxuridine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Franco Muggia, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 9, 2009
• Study Start: December 1, 2002
• Primary Completion: March 1, 2007
• Study Completion: February 1, 2012
• Last Updated: March 11, 2016

Record last verified: 2016-03

Locations

US (3)