NCT00010023

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 chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of capecitabine combined with cisplatin in treating patients who have locally advanced or metastatic solid tumors .

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Last Updated

April 5, 2011

Status Verified

April 1, 2011

Enrollment Period

7 years

First QC Date

February 2, 2001

Last Update Submit

April 4, 2011

Conditions

Cancer

Keywords

stage IV breast cancerstage IIIA breast cancerrecurrent breast cancerstage III gastric cancerstage IV gastric cancerrecurrent gastric cancerstage IIIB breast cancerstage IIIC breast cancerrecurrent non-small cell lung cancerstage III pancreatic cancerrecurrent pancreatic cancerstage III esophageal cancerstage IV esophageal cancerrecurrent esophageal cancerextensive stage small cell lung cancerrecurrent small cell lung cancermetastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumorlocalized unresectable adult primary liver canceradvanced adult primary liver cancerrecurrent adult primary liver cancersmall intestine adenocarcinomaunresectable gallbladder cancerrecurrent gallbladder cancerunresectable extrahepatic bile duct cancerrecurrent extrahepatic bile duct cancerrecurrent small intestine cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung canceruntreated metastatic squamous neck cancer with occult primaryrecurrent metastatic squamous neck cancer with occult primarypulmonary carcinoid tumorstage III squamous cell carcinoma of the lip and oral cavitystage III basal cell carcinoma of the lipstage III verrucous carcinoma of the oral cavitystage III mucoepidermoid carcinoma of the oral cavitystage III adenoid cystic carcinoma of the oral cavitystage 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 III squamous cell carcinoma of the oropharynxstage III lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxrecurrent lymphoepithelioma of the oropharynxstage III squamous cell carcinoma of the nasopharynxstage III lymphoepithelioma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxrecurrent lymphoepithelioma of the nasopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage III verrucous carcinoma of the larynxstage IV squamous cell carcinoma of the larynxstage IV verrucous carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxstage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage III inverted papilloma of the paranasal sinus and nasal cavitystage III midline lethal granuloma of the paranasal sinus and nasal cavitystage III esthesioneuroblastoma of the paranasal sinus and nasal cavitystage 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 cavitynewly diagnosed carcinoma of unknown primarycarcinoma of the appendixrecurrent carcinoma of unknown primarygastrointestinal stromal tumorrecurrent salivary gland cancerstage III salivary gland cancerstage IV salivary gland cancerstage IV pancreatic cancer

Interventions

capecitabineDRUG
cisplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic or locally advanced inoperable carcinoma of the upper gastrointestinal tract, head and neck, lung, breast, or carcinoma of unknown primary * Previously treated and/or resected primary tumors allowed * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Not specified Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 2 mg/dL\* * AST less than 3 times upper limit of normal (ULN)\* * Alkaline phosphatase no greater than 3 times ULN\* NOTE: \* Unless related to tumor (e.g., cholangiocarcinoma or hepatic metastases) Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min * BUN no greater than 30 mg/dL\* NOTE: \* Unless related to tumor (e.g., cholangiocarcinoma or hepatic metastases) Other: * No other medical condition that could interfere with oral medication absorption * No prior or concurrent malignancy except surgically cured carcinoma of the cervix or basal cell or squamous cell carcinoma skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 6 months since prior fluorouracil or cisplatin * At least 3 weeks since other prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since 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)

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Related Publications (1)

  • Chen TT, Ryan T, Potmesil M, et al.: Cisplatin/capecitabine: tolerance and activity in patients with upper gastrointestinal cancers. [Abstract] American Society of Clinical Oncology 2004 Gastrointestinal Cancers Symposium, 22-24 January 2004, San Francisco, CA. A-53, 2004.

    RESULT

MeSH Terms

Conditions

NeoplasmsBreast NeoplasmsStomach NeoplasmsCarcinoma, Non-Small-Cell LungPancreatic NeoplasmsEsophageal NeoplasmsSmall Cell Lung CarcinomaCarcinoma, HepatocellularGallbladder NeoplasmsBile Duct NeoplasmsSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, OlfactoryAppendiceal NeoplasmsNeoplasms, Unknown PrimaryGastrointestinal Stromal TumorsSalivary Gland Neoplasms

Interventions

CapecitabineCisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesHead and Neck NeoplasmsEsophageal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsLiver DiseasesBiliary Tract NeoplasmsBiliary Tract DiseasesGallbladder DiseasesBile Duct DiseasesCarcinoma, Squamous CellNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesCecal NeoplasmsIntestinal NeoplasmsCecal DiseasesIntestinal DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Franco M. Muggia, MD

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2001

First Posted

January 27, 2003

Study Start

August 1, 2000

Primary Completion

August 1, 2007

Last Updated

April 5, 2011

Record last verified: 2011-04

Locations

US(1)