NCT00005860

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 may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin with or without floxuridine and leucovorin in treating patients who have metastatic cancer of the peritoneum.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

April 2, 2004

Completed
Last Updated

April 26, 2011

Status Verified

May 1, 2002

First QC Date

June 2, 2000

Last Update Submit

April 23, 2011

Conditions

Cancer

Keywords

stage IV colon cancerstage IV gastric cancerrecurrent gastric cancerrecurrent pancreatic cancerrecurrent colon cancerregional neuroblastomastage 4S neuroblastomarecurrent neuroblastomaregional gastrointestinal carcinoid tumormetastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumoradvanced adult primary liver cancerrecurrent adult primary liver cancergastrinomasmall intestine adenocarcinomasmall intestine lymphomasmall intestine leiomyosarcomaunresectable gallbladder cancerrecurrent gallbladder cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerrecurrent small intestine cancerinsulinomarecurrent islet cell carcinomaWDHA syndromesomatostatinomapancreatic polypeptide tumorglucagonomaregional pheochromocytomametastatic pheochromocytomarecurrent pheochromocytomaextragonadal germ cell tumorliver metastasesmalignant ascitesnewly diagnosed carcinoma of unknown primarycarcinoma of the appendixpseudomyxoma peritoneifallopian tube cancerprimary peritoneal cavity cancerrecurrent carcinoma of unknown primarygastrointestinal stromal tumorstage IV pancreatic cancer

Interventions

floxuridineDRUG
leucovorin calciumDRUG
oxaliplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic or unresectable cancer largely confined to the peritoneal cavity * Fully resected and/or electrocauterized metastatic disease involving the peritoneum (stage IV, no residual disease) allowed * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other: * No history of allergy to platinum compounds or antiemetics that would preclude study * No other uncontrolled illness (e.g., active infection) * No evidence of neuropathy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered Surgery: * See Disease Characteristics Other: * No other concurrent investigational agents * No concurrent antiretroviral therapy (HAART)

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

NeoplasmsColonic NeoplasmsStomach NeoplasmsPancreatic NeoplasmsNeuroblastomaCarcinoma, HepatocellularGastrinomaGallbladder NeoplasmsBile Duct NeoplasmsInsulinomaCarcinoma, Islet CellVipomaSomatostatinomaGlucagonomaPheochromocytomaAppendiceal NeoplasmsPseudomyxoma PeritoneiFallopian Tube NeoplasmsNeoplasms, Unknown PrimaryGastrointestinal Stromal Tumors

Interventions

FloxuridineLeucovorinOxaliplatin

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueAdenocarcinomaCarcinomaLiver NeoplasmsLiver DiseasesBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesBile Duct DiseasesAdenoma, Islet CellAdenomaCarcinoma, NeuroendocrineNeuroendocrine TumorsParagangliomaCecal NeoplasmsCecal DiseasesAdenocarcinoma, MucinousNeoplasms, Cystic, Mucinous, and SerousGenital Neoplasms, FemaleUrogenital NeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Connective TissueNeoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

DeoxyuridineUridinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCoordination ComplexesOrganic Chemicals

Study Officials

  • Leonard B. Saltz, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2000

First Posted

April 2, 2004

Study Start

April 1, 2000

Last Updated

April 26, 2011

Record last verified: 2002-05

Locations

US(1)