NCT00021047

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/II trial to study the effectiveness of combining epirubicin, carboplatin, and capecitabine in treating patients who have unresectable locally advanced, metastatic, or recurrent solid tumor.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 2001

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

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, 2001

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

First QC Date

July 11, 2001

Last Update Submit

March 7, 2012

Conditions

Esophageal CancerExtrahepatic Bile Duct CancerGastric CancerHead and Neck CancerLiver CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV gastric cancerrecurrent gastric cancerstage II esophageal cancerstage III esophageal cancerstage IV esophageal cancerrecurrent esophageal canceradvanced adult primary liver cancerrecurrent adult primary liver cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerunspecified adult solid tumor, protocol specificuntreated metastatic squamous neck cancer with occult primaryrecurrent metastatic squamous neck cancer with occult primarystage IV squamous cell carcinoma of the lip and oral cavitystage IV basal cell carcinoma of the lipstage IV verrucous carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavityrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent basal cell carcinoma of the liprecurrent verrucous carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent adenoid cystic carcinoma of the oral cavitystage IV squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxrecurrent lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxrecurrent lymphoepithelioma of the nasopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynxstage IV verrucous carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxstage IV squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV inverted papilloma of the paranasal sinus and nasal cavitystage IV midline lethal granuloma of the paranasal sinus and nasal cavitystage IV esthesioneuroblastoma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent inverted papilloma of the paranasal sinus and nasal cavityrecurrent midline lethal granuloma of the paranasal sinus and nasal cavityrecurrent esthesioneuroblastoma of the paranasal sinus and nasal cavityrecurrent salivary gland cancerstage IV salivary gland cancer

Interventions

capecitabineDRUG
carboplatinDRUG
epirubicin hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor * Progressive disease on standard therapy, including: * Locally advanced, unresectable primary or recurrent tumor OR * Metastatic disease * Previously untreated metastatic cancer for which study regimen represents reasonable initial chemotherapy with palliative intent (e.g., metastatic gastric cancer, hepatobiliary cancer, or cancers for which no effective standard therapy exists) allowed * Phase II portion: * Diagnosis of cancer of the upper aerodigestive tract (head and neck, esophagus, stomach, or hepatobiliary) * No potential curative treatment options including surgery, radiotherapy, chemoradiotherapy, or combination chemotherapy * No leukemia or lymphoma * No primary CNS malignancies or CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * AST and ALT no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 1.6 mg/dL Cardiovascular: * LVEF at least 50% * No symptomatic congestive heart failure * No unstable angina * No cardiac arrhythmia Other: * No serious concurrent medical illness that would preclude study participation * No active infections requiring IV antibiotic therapy * No history of allergy to platinum compounds, mannitol, or antiemetics used with study drugs * No history of severe intolerance to fluorouracil * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 4 weeks since prior immunotherapy and recovered Chemotherapy: * See Disease Characteristics * More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) and recovered * No prior cumulative doxorubicin dose of more than 300 mg/m2 Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 2 weeks since prior radiotherapy and recovered * At least 8 weeks since prior strontium chloride Sr 89 Surgery: * See Disease Characteristics * Recovered from prior surgery Other: * At least 4 weeks since prior sorivudine or brivudine * No concurrent sorivudine or brivudine * No concurrent cimetidine * No concurrent antiretroviral therapy for HIV-positive patients

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

Sponsors & Collaborators

Study Sites (3)

Center for Cancer Research

Bethesda, Maryland, 20889-5105, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Naval Medical Center, Portsmouth

Portsmouth, Virginia, 23708-2197, United States

Location

MeSH Terms

Conditions

Esophageal NeoplasmsBile Duct NeoplasmsStomach NeoplasmsHead and Neck NeoplasmsLiver NeoplasmsCarcinoma, HepatocellularSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, OlfactorySalivary Gland Neoplasms

Interventions

CapecitabineCarboplatinEpirubicin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesStomach DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, Squamous CellNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic ChemicalsDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Brian P. Monahan, MD, FACP

    National Cancer Institute (NCI)

  • Eva Szabo, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

July 1, 2001

Study Completion

June 1, 2004

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

US(3)