NCT00019019

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of carboxyamidotriazole and paclitaxel in treating patients with advanced solid tumors or refractory lymphomas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 1994

Longer than P75 for phase_1

Geographic Reach
1 country

2 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

October 1, 1994

Completed
6.8 years 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
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

11.8 years

First QC Date

July 11, 2001

Last Update Submit

March 14, 2012

Conditions

Brain and Central Nervous System TumorsBreast CancerKidney CancerLung CancerLymphomaMelanoma (Skin)Ovarian CancerSmall Intestine CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomastage IV breast cancerstage IIIA breast cancerrecurrent breast cancerstage IIIB breast cancerrecurrent non-small cell lung cancerrecurrent adult Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomastage III renal cell cancerstage IV renal cell cancerrecurrent renal cell cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerrecurrent adult brain tumorsmall intestine lymphomaadult brain stem gliomaadult craniopharyngiomaadult medulloblastomaadult meningiomaadult glioblastomastage III melanomastage IV melanomarecurrent melanomastage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IIIC breast cancerstage IV non-small cell lung cancerunspecified adult solid tumor, protocol specificstage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomaadult anaplastic astrocytomaadult myxopapillary ependymomaadult anaplastic ependymomaadult anaplastic oligodendrogliomaadult mixed gliomaadult central nervous system germ cell tumorprimary central nervous system non-Hodgkin lymphomaadult pilocytic astrocytomaadult subependymomaadult ependymoblastomaadult pineocytomaadult pineoblastomaadult meningeal hemangiopericytomaintraocular lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomaadult choroid plexus tumorstage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromerecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomaadult grade III meningiomaadult oligodendrogliomaadult giant cell glioblastomaadult gliosarcoma

Interventions

carboxyamidotriazoleDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically diagnosed solid tumor (i.e., breast and ovarian epithelial carcinomas) or lymphoma * Slides reviewed at the NCI Laboratory of Pathology * Failure on therapy of proven efficacy for the disease * Prior therapy not required for the following metastatic diseases: * Melanoma * Non-small cell lung cancer * Renal cell carcinoma * No brain metastases * Primary brain tumors (such as glioblastoma multiforme) with stable neurologic deficits allowed * Measurable or evaluable disease required * Demonstrated by physical exam or on radiograph within 2 weeks prior to initiation of treatment OR * Elevated PSA associated with prostate cancer * Other marker-only disease ineligible PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hematocrit at least 27% Hepatic: * Liver function tests no greater than 2 times upper limit of normal * Bilirubin normal * PT or PTT no greater than 1.25 times upper limit of normal * Clotting parameters normal * No concurrent anticoagulants other than 1 mg of warfarin per day for prophylaxis Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 45 mL/min * No kidney obstruction Cardiovascular: * No cardiac conduction defect requiring antiarrhythmics * No evidence of myocardial infarction or other myocardial damage within past 6 months Other: * HIV negative * No concurrent infection * No guaiac-positive stool test * No neuropathy greater than grade I (unless associated with fixed-deficit primary brain tumors) * Not pregnant or nursing * Fertile patients must use effective contraception during and for 2 months after study PRIOR CONCURRENT THERAPY: * Recovery from prior therapy required Biologic therapy: * At least 4 weeks since prior biologic therapy Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks since mitomycin, nitrosoureas, or carboplatin) * No progression on carboxyamidotriazole or paclitaxel * At least 6 months between treatment and relapse Endocrine therapy: * At least 4 weeks since prior hormonal therapy * No concurrent corticosteroids except as physiologic replacement Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * Not specified Other: * At least 1 week since prior therapeutic antibiotics * Concurrent prophylactic antibiotics allowed except imidazole antifungals (e.g., ketoconazole, fluconazole) * No concurrent calcium channel blockers

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

Sponsors & Collaborators

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Medical Oncology Clinical Research Unit

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Kohn EC, Reed E, Sarosy GA, Minasian L, Bauer KS, Bostick-Bruton F, Kulpa V, Fuse E, Tompkins A, Noone M, Goldspiel B, Pluda J, Figg WD, Liotta LA. A phase I trial of carboxyamido-triazole and paclitaxel for relapsed solid tumors: potential efficacy of the combination and demonstration of pharmacokinetic interaction. Clin Cancer Res. 2001 Jun;7(6):1600-9.

    PMID: 11410496RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsBreast NeoplasmsKidney NeoplasmsLung NeoplasmsLymphomaMelanomaOvarian NeoplasmsHodgkin DiseaseCarcinoma, Non-Small-Cell LungLymphoma, T-Cell, CutaneousCarcinoma, Renal CellCarcinoma, Ovarian EpithelialBrain NeoplasmsCraniopharyngiomaMedulloblastomaMeningiomaGlioblastomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaAstrocytomaEpendymomaOligodendrogliomaGliomaGlioma, SubependymalNeuroectodermal Tumors, PrimitivePinealomaIntraocular LymphomaLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticChoroid Plexus NeoplasmsMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellGliosarcoma

Interventions

carboxyamido-triazolePaclitaxel

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinoma, BronchogenicBronchial NeoplasmsLymphoma, T-CellAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialBrain DiseasesCentral Nervous System DiseasesNeoplasms, NeuroepithelialNeoplasms, Vascular TissueMeningeal NeoplasmsLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye NeoplasmsLymphadenopathyCerebral Ventricle NeoplasmsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Virginia Kwitkowski, MS, RN, CS, CRNP

    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

October 1, 1994

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

US(2)