NCT00006038

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery and intraperitoneal chemotherapy in treating patients who have locally advanced stomach cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 2000

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

February 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
1 year until next milestone

First Posted

Study publicly available on registry

February 12, 2004

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

3 years

First QC Date

July 5, 2000

Last Update Submit

June 17, 2013

Conditions

Esophageal CancerGastric Cancer

Keywords

stage II gastric cancerstage III gastric cancerstage IV gastric cancerstage II esophageal cancerstage III esophageal canceradenocarcinoma of the stomachadenocarcinoma of the esophagus

Interventions

cisplatinDRUG
docetaxelDRUG
floxuridineDRUG
fluorouracilDRUG
leucovorin calciumDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven locally advanced adenocarcinoma of the stomach or gastroesophageal (GE) junction that is potentially curable by surgery Patients with tumors involving the GE junction must have the bulk of their disease in the stomach No tumors of the distal esophagus or GE junction that extend less than 2 cm into the stomach Tumor stage T2, N1-2, M0 OR T3-4, any N, M0 by physical exam, CT scan, and laparoscopy PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin less than 2 mg/dL SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) if alkaline phosphatase no greater than ULN OR Alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT no greater than ULN Ineligible if SGOT and SGPT greater than 1.5 times ULN AND alkaline phosphatase greater than 2.5 times ULN Renal: Blood urea nitrogen no greater than 30 mg/dL Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance greater than 50 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease No active angina or myocardial infarction within the past 6 months No history of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality Other: No clinically significant auditory impairment No worse than grade 2 preexisting peripheral neuropathy No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy No psychiatric disorder that would preclude compliance PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Esophageal NeoplasmsStomach NeoplasmsAdenocarcinoma Of Esophagus

Interventions

CisplatinDocetaxelFloxuridineFluorouracilLeucovorin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDeoxyuridineUridinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesUracilPyrimidinonesFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • David Paul Kelsen, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2000

First Posted

February 12, 2004

Study Start

February 1, 2000

Primary Completion

February 1, 2003

Study Completion

February 1, 2003

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)