NCT00183911

Brief Summary

The purpose of this study is to evaluate the side effects of a new treatment for stomach cancer which may potentially improve the prognosis of this cancer. Our principle objective is to improve the results of standard chemotherapy and radiation after surgery of patients with gastric cancer. The intra-abdominal (intraperitoneal) administration of floxuridine (FUDR) is a procedure that we have studied and have determined it is a safe treatment. In this study, we want to evaluate the side effects of this treatment when it is given after surgery but before standard intravenous chemotherapy and radiation. Study treatment will start with surgical removal of the part of the stomach with cancer, together with surrounding tissues and lymph nodes. After surgery, patients will get treatment with a chemotherapy drug, FUDR, administered directly into the abdomen. This is called intraperitoneal chemotherapy. After this treatment patients will receive repeated intravenous injection of two drugs, 5-fluorouracil and leucovorin alone or combined with irradiation of the abdomen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2003

Typical duration for phase_2

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

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

3.1 years

First QC Date

September 9, 2005

Last Update Submit

May 20, 2014

Conditions

Gastric AdenocarcinomaGastric Cancer

Interventions

floxuridine, 5-Fluorouracil, leucovorinDRUG
External Beam RadiotherapyPROCEDURE
SurgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic dx of locally advanced gastric adenocarcinoma (requires upper endoscopy with bx of lesion and CT scan of chest, abdomen, and pelvis with iv and oral contrast or other methods of imaging to confirm absence of metastatic dz) (Untreated patients with histologically documented gastric/GEJ ca stages IB-IV \[M0\] are eligible)
  • Based on post-op pathological findings, diagnosis and staging has to confirm stage IB-IV (M0) adenocarcinoma of stomach or GEJ.
  • Patients who underwent emergency surgery for indications such as GI obstruction, perforation, or hemorrhage, or patients with surgery already performed, are eligible provided surgery is considered curative
  • ECOG performance status 0-2
  • AGC greater than or equal to 1.5; platelets greater than or equal to 100,000; Hgb greater than or equal to 9.0· Total bilirubin less than or eqal to 2.0; SGOT/SGPT less than or equal to 2.5 x uln; alk phos less than or equal to 2.5 x uln
  • BUN less than or equal to 30; creatinine less than or equal to 1.5 or CrCl \>60 ml/min
  • Negative b-HCG pregnancy test (females with reproductive potential)
  • PT, aPTT, and thrombin time within range of normal
  • Evidence of at least unilateral renal function as established by CT scan with contrast or nephrogram. (If only one kidney is present, at least 2/3 of the functioning kidney must be excluded from any RT port)

You may not qualify if:

  • Prior radiation therapy, chemotherapy or immunotherapy
  • Presence of another active invasive malignancy (Except for adequately treated basal cell or squamous cell skin ca, in-situ cervical ca, or other cancer for which patient has been disease-free for at least 5 yrs)
  • Active or uncontrolled infection, including HIV
  • Psychiatric disorders that would interfere with informed consent· Pregnant or nursing women (Patients of reproductive age must agree to use effective contraceptive method)
  • Any other severe concurrent disease, which in the judgment of MD would make patient inappropriate for study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.S.C. / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

FloxuridineFluorouracilLeucovorinSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

DeoxyuridineUridinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesUracilPyrimidinonesFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Syma Iqbal, M.D.

    U.S.C./Norris Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

November 1, 2003

Primary Completion

December 1, 2006

Study Completion

April 1, 2007

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

US(1)