NCT00093678

Brief Summary

RATIONALE: Celecoxib may help relieve moderate or severe pain associated with cancer. It may also decrease weight loss and improve muscle strength in cancer patients. PURPOSE: This randomized clinical trial is studying celecoxib to see how well it works in managing pain, weight loss, and weakness in patients with advanced cancer.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2004

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

First QC Date

October 6, 2004

Last Update Submit

October 6, 2015

Conditions

CachexiaLymphomaMelanoma (Skin)Ovarian CancerPainSarcomaUnspecified Adult Solid Tumor, Protocol Specific

Keywords

paincachexiaunspecified adult solid tumor, protocol specificrecurrent uterine sarcomastage III uterine sarcomastage IV uterine sarcomaovarian sarcomarecurrent adult soft tissue sarcomastage III adult soft tissue sarcomastage IV adult soft tissue sarcomarecurrent melanomastage III melanomastage IV melanomachondrosarcomametastatic osteosarcomarecurrent osteosarcomaclassic Kaposi sarcomaAIDS-related Kaposi sarcomarecurrent Kaposi sarcomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomaintraocular lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaprimary central nervous system lymphomarecurrent adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomaWaldenstrom macroglobulinemiaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomaadult grade III lymphomatoid granulomatosisrecurrent adult grade III lymphomatoid granulomatosisrecurrent mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomaAIDS-related peripheral/systemic lymphomaAIDS-related primary CNS lymphomaimmunosuppressive treatment related Kaposi sarcoma

Interventions

celecoxibDRUG
anticachectic therapyPROCEDURE
nutritional supportPROCEDURE
pain therapyPROCEDURE
supportive care/therapyPROCEDURE

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignant tumor of 1 of the following types: * Carcinoma * Sarcoma * Melanoma * Lymphoma * Metastatic or unresectable disease * Clear evidence of residual disease after most recent prior treatment * Measurable disease not required * Patient has elected to receive supportive care only rather than active cancer treatment (e.g., palliative chemotherapy) * Brain metastases allowed provided the following criteria are met: * Completed treatment for CNS disease (e.g., whole brain radiotherapy, surgery, or stereotactic surgery) * Clinically stable disease for at least 4 weeks after treatment completion * No requirement for corticosteroids PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-3 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * ALT and AST ≤ 5 times ULN Renal * Creatinine ≤ 1.6 mg/dL Cardiovascular * No myocardial infarction within the past 6 months * No transient ischemic attack within the past 6 months * No stroke within the past 6 months * No angina pectoris requiring medical therapy * No other active coronary artery disease or cerebrovascular disease Other * No active gastrointestinal (GI) ulcer disease * No GI bleeding * No history of allergic reaction, urticaria, or bronchospasm after taking NSAIDs, aspirin, or sulfonamide drugs * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Concurrent hematopoietic growth factors for cytopenia or fatigue allowed * No concurrent biologic anticancer agents Chemotherapy * See Disease Characteristics Endocrine therapy * See Disease Characteristics * No concurrent corticosteroids for management of cancer-related symptoms or other illness * No concurrent hormonal therapy * Concurrent luteinizing hormone-releasing hormone therapy allowed for prostate cancer patients provided drug was initiated at least 6 months ago AND there is unequivocal evidence of progressive disease, defined by 1 of the following criteria: * Rising prostate-specific antigen (PSA) on 3 successive measurements * Rising PSA on 2 measurements taken at least 2 weeks apart * New lesions on bone scan Radiotherapy * See Disease Characteristics Surgery * See Disease Characteristics Other * Concurrent bisphosphonates for management of osseous metastases or hypercalcemia allowed * No concurrent cytotoxic drugs * No other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin

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

Sponsors & Collaborators

MeSH Terms

Conditions

CachexiaLymphomaMelanomaOvarian NeoplasmsPainSarcomaChondrosarcomaOsteosarcomaAIDS-related Kaposi sarcomaSarcoma, KaposiBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellIntraocular LymphomaHodgkin DiseaseLymphoma, T-Cell, CutaneousLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyWaldenstrom MacroglobulinemiaMycosis FungoidesSezary SyndromePrecursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

CelecoxibNutritional SupportAnalgesiaPalliative Care

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinnessNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersNeurologic ManifestationsNeoplasms, Connective and Soft TissueNeoplasms, Connective TissueNeoplasms, Bone TissueHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsNeoplasms, Vascular TissueEpstein-Barr Virus InfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesEye NeoplasmsLymphoma, T-CellLymphadenopathyNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNutrition TherapyTherapeuticsAnesthesia and AnalgesiaPatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Donald P. Lawrence, MD

    Tufts Medical Center

    STUDY CHAIR

  • Michael J. Fisch, MD, MPH, FACP

    M.D. Anderson Cancer Center

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

October 6, 2004

First Posted

October 8, 2004

Last Updated

October 8, 2015

Record last verified: 2015-10