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

NCT00848783 | Terminated Phase 2 Results DMC

• 2 other identifiers: 07-837NYU 05-20
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Gastric Cancer; Gastric Adenocarcinoma; Esophageal Cancer

Keywords

gastric cancer; gastroesophageal junction; stomach cancer; intraperitoneal infusion; capecitabine; irinotecan; cisplatin; floxuridine

Outcome Measures

Primary Outcomes (1)

• Number of Patients With One-year Recurrence-free Survival

  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 Outcomes (1)

• Overall Survival Rate; Toxicity; Evaluation of Sites of Relapse of Failing Patients

  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

Study Arms (2)

A-with IP Floxuridine

EXPERIMENTAL

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: Irinotecan; Drug: Cisplatin; Procedure: Surgery; Drug: Floxuridine; Drug: Capecitabine

B-Without IP Floxuridine

EXPERIMENTAL

Same as Arm A except no postoperative IP treatment.

Drug: Irinotecan; Drug: Cisplatin; Procedure: Surgery; Drug: Capecitabine

Interventions

Irinotecan DRUG

Also known as: CPT-11

A-with IP Floxuridine; B-Without IP Floxuridine

Cisplatin DRUG

A-with IP Floxuridine; B-Without IP Floxuridine

Surgery PROCEDURE

A-with IP Floxuridine; B-Without IP Floxuridine

Floxuridine DRUG

Also known as: FUDR

A-with IP Floxuridine

Capecitabine DRUG

Also known as: Xeloda

A-with IP Floxuridine; B-Without IP Floxuridine

Eligibility Criteria

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

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (3)

Norris Cancer Center

Los Angeles, California, 90033, United States

Location

Bellevue Hospital

New York, New York, 10016, United States

Location

NYU Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms

Interventions

Irinotecan; Cisplatin; Surgical Procedures, Operative; Floxuridine; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Deoxycytidine; Cytidine; Fluorouracil; Uracil; Pyrimidinones

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Franco Muggia, MD
• Organization: NYU Cancer Institute

franco.muggia@nyumc.org

212-263-6485

Study Officials

• Franco Muggia, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: May 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2012
• Last Updated: January 8, 2018
• Results First Posted: December 10, 2012

Record last verified: 2017-12

Locations

US (3)