NCT00004103

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with surgery may kill more tumor cells. PURPOSE: This phase II trial is studying how well irinotecan and cisplatin followed by surgery, floxuridine, and cisplatin work in treating patients with stomach cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 1998

Longer than P75 for phase_2 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

April 6, 2011

Status Verified

April 1, 2011

Enrollment Period

8.7 years

First QC Date

December 10, 1999

Last Update Submit

April 5, 2011

Conditions

Gastric Cancer

Keywords

stage I gastric cancerstage II gastric cancerstage III gastric cancerstage IV gastric cancer

Interventions

cisplatinDRUG
floxuridineDRUG
irinotecan hydrochlorideDRUG
adjuvant therapyPROCEDURE
conventional surgeryPROCEDURE
neoadjuvant therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven, previously untreated gastric cancer * Stage IB, II, III, or IV (T3-4, N0 OR any T, N1-2, M0) * No metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 4000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin less than 2 mg/dL * SGOT/SGPT no greater than 2 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 3 times ULN * PT, aPTT, and TT normal * No Gilbert's disease Renal: * BUN no greater than 30 mg/dL * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No myocardial infarction within the past 3 months * No congestive heart failure requiring therapy Other: * No other invasive malignancy in the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix * No active or uncontrolled infection * HIV negative * No other severe concurrent disease * No psychiatric disorders that would preclude compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for gastric cancer Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for gastric cancer Surgery: * No prior surgery for gastric cancer * No emergent need for surgery for gastrointestinal obstruction, perforation, or hemorrhage

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

Sponsors & Collaborators

Study Sites (1)

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Related Publications (1)

  • Newman E, Potmesil M, Ryan T, Marcus S, Hiotis S, Yee H, Norwood B, Wendell M, Muggia F, Hochster H. Neoadjuvant chemotherapy, surgery, and adjuvant intraperitoneal chemotherapy in patients with locally advanced gastric or gastroesophageal junction carcinoma: a phase II study. Semin Oncol. 2005 Dec;32(6 Suppl 9):S97-100. doi: 10.1053/j.seminoncol.2005.06.002.

    PMID: 16399443RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

CisplatinFloxuridineIrinotecanChemotherapy, AdjuvantNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsDeoxyuridineUridinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCamptothecinAlkaloidsCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Elliot Newman, MD

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 1999

First Posted

January 27, 2003

Study Start

July 1, 1998

Primary Completion

March 1, 2007

Study Completion

June 1, 2009

Last Updated

April 6, 2011

Record last verified: 2011-04

Locations

US(1)