NCT00049296

Brief Summary

RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining thalidomide with docetaxel may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining thalidomide with docetaxel in treating patients who have advanced cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Jul 2002

Typical duration for phase_1 cancer

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

July 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

June 11, 2010

Status Verified

June 1, 2010

Enrollment Period

2.4 years

First QC Date

November 12, 2002

Last Update Submit

June 10, 2010

Conditions

Cancer

Keywords

adult anaplastic astrocytomamale breast canceradult anaplastic oligodendrogliomaadult meningeal hemangiopericytomaadult brain stem gliomaadult central nervous system germ cell tumoradult choroid plexus tumoradult craniopharyngiomaadult ependymoblastomaadult glioblastomaadult pilocytic astrocytomaadult anaplastic ependymomaadult medulloblastomaadult meningiomaadult pineoblastomaadult pineocytomaadult subependymomaadult myxopapillary ependymomaadvanced adult primary liver canceranterior urethral cancercarcinoma of the appendixchondrosarcomaclassic Kaposi sarcomaAIDS-related Kaposi sarcomaimmunosuppressive treatment related Kaposi sarcomarecurrent Kaposi sarcomaclear cell sarcoma of the kidneydisseminated neuroblastomaextensive stage small cell lung cancergastrointestinal stromal tumormetastatic gastrointestinal carcinoid tumormetastatic osteosarcomametastatic transitional cell cancer of the renal pelvis and uretermetastatic Ewing sarcoma/peripheral primitive neuroectodermal tumoradult mixed gliomaovarian sarcomaposterior urethral cancerprimary central nervous system lymphomapulmonary carcinoid tumorrecurrent adenoid cystic carcinoma of the oral cavityrecurrent adult brain tumorrecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Burkitt lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult primary liver cancerrecurrent adult soft tissue sarcomarecurrent anal cancerrecurrent basal cell carcinoma of the liprecurrent bladder cancerrecurrent breast cancerrecurrent colon cancerrecurrent esophageal cancerrecurrent esthesioneuroblastoma of the paranasal sinus and nasal cavityrecurrent extrahepatic bile duct cancerrecurrent gallbladder cancerrecurrent gastric cancerrecurrent gastrointestinal carcinoid tumorrecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent inverted papilloma of the paranasal sinus and nasal cavityrecurrent lymphoepithelioma of the nasopharynxrecurrent lymphoepithelioma of the oropharynxrecurrent mantle cell lymphomarecurrent melanomarecurrent metastatic squamous neck cancer with occult primaryrecurrent midline lethal granuloma of the paranasal sinus and nasal cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent neuroblastomarecurrent non-small cell lung cancerrecurrent osteosarcomarecurrent pancreatic cancerrecurrent rectal cancerrecurrent renal cell cancerrecurrent small cell lung cancerrecurrent small intestine cancerrecurrent squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent transitional cell cancer of the renal pelvis and ureterrecurrent Ewing sarcoma/peripheral primitive neuroectodermal tumorrecurrent urethral cancerrecurrent uterine sarcomarecurrent verrucous carcinoma of the larynxrecurrent verrucous carcinoma of the oral cavityrefractory multiple myelomarhabdoid tumor of the kidneysmall intestine adenocarcinomasmall intestine leiomyosarcomasmall intestine lymphomastage II esophageal cancerstage II pancreatic cancerstage III esophageal cancerstage III multiple myelomastage III pancreatic cancerstage IV adenoid cystic carcinoma of the oral cavitystage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Burkitt lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV anal cancerstage IV basal cell carcinoma of the lipstage IV bladder cancerstage IV breast cancerstage IV colon cancerstage IV esophageal cancerstage IV esthesioneuroblastoma of the paranasal sinus and nasal cavitystage IV gastric cancerstage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV inverted papilloma of the paranasal sinus and nasal cavitystage IV lymphoepithelioma of the nasopharynxstage IV lymphoepithelioma of the oropharynxstage IV mantle cell lymphomastage IV melanomastage IV midline lethal granuloma of the paranasal sinus and nasal cavitystage IV mucoepidermoid carcinoma of the oral cavitystage IV non-small cell lung cancerstage IV rectal cancerstage IV renal cell cancerstage IV squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV uterine sarcomastage IV verrucous carcinoma of the larynxstage IV verrucous carcinoma of the oral cavityunresectable extrahepatic bile duct cancerunresectable gallbladder cancerunspecified adult solid tumor, protocol specificurethral cancer associated with invasive bladder cancerrecurrent salivary gland cancerstage IV salivary gland cancerrecurrent marginal zone lymphomarecurrent small lymphocytic 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 lymphomastage IV adult soft tissue sarcomaadult grade III meningiomaadult oligodendrogliomaadult giant cell glioblastomaadult gliosarcomastage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Determine the maximum tolerated dose of docetaxel when administered with thalidomide in patients with advanced solid tumors, multiple myeloma, and non-Hodgkin's lymphoma.

    Weekly courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

Interventions

docetaxelDRUG

Patients receive docetaxel IV over 30 minutes once weekly. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the maximum tolerated dose (MTD) is determined.

thalidomideDRUG

Patients receive oral thalidomide twice daily. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the maximum tolerated dose (MTD) is determined.

Also known as: alpha-phthalimidoglutarimide, N-phthaloylglutamimide, N-phthalylglutamic acid imide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed malignancy not amenable to curative surgery, radiotherapy, or chemotherapy * Tumor types may include any of the following: * Any solid tumor including, but not limited to, head and neck, breast, lung, gastrointestinal, genitourinary, melanoma, and sarcoma * Primary CNS neoplasms if the following are true: * Received primary radiotherapy * No concurrent corticosteroids or has been on a stable corticosteroid dose for at least 30 days * No concurrent enzyme-inducible anti-epileptic medications (i.e., carbamazepine or phenytoin) * Multiple myeloma * Non-Hodgkin's lymphoma * No refractory or relapsed acute or chronic leukemia * Measurable or evaluable disease * No life-prolonging therapy available * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * At least 4 months Hematopoietic * WBC at least 4,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin no greater than upper limit of normal (ULN) * AST and/or ALT no greater than 2.5 times ULN if alkaline phosphatase less than ULN OR * Alkaline phosphatase no greater than 4 times ULN if AST/ALT less than ULN Renal * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular * No New York Heart Association class III or IV heart disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 effective methods of contraception 4 weeks before, during, and 4 weeks after study * Willing and able to comply with FDA-mandated STEPS program * No peripheral neuropathy grade 2 or greater * No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No more than 2 prior courses of mitomycin Endocrine therapy * See Disease Characteristics Radiotherapy * At least 4 weeks since prior large-field radiotherapy and recovered Surgery * Not specified Other * At least 3 weeks since other prior anticancer therapy and recovered

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

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Related Publications (1)

  • Sanborn SL, Cooney MM, Dowlati A, Brell JM, Krishnamurthi S, Gibbons J, Bokar JA, Nock C, Ness A, Remick SC. Phase I trial of docetaxel and thalidomide: a regimen based on metronomic therapeutic principles. Invest New Drugs. 2008 Aug;26(4):355-62. doi: 10.1007/s10637-008-9137-0. Epub 2008 May 10.

    PMID: 18470481RESULT

MeSH Terms

Conditions

NeoplasmsAstrocytomaBreast Neoplasms, MaleOligodendrogliomaChoroid Plexus NeoplasmsCraniopharyngiomaNeuroectodermal Tumors, PrimitiveGlioblastomaEpendymomaMedulloblastomaMeningiomaPinealomaGlioma, SubependymalAppendiceal NeoplasmsChondrosarcomaAIDS-related Kaposi sarcomaSarcoma, KaposiGastrointestinal Stromal TumorsOsteosarcomaNeuroectodermal Tumors, Primitive, PeripheralGliomaBrain NeoplasmsLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinBurkitt LymphomaLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaCarcinoma, HepatocellularSarcomaAnus NeoplasmsUrinary Bladder NeoplasmsBreast NeoplasmsColonic NeoplasmsEsophageal NeoplasmsEsthesioneuroblastoma, OlfactoryBile Duct NeoplasmsGallbladder NeoplasmsStomach NeoplasmsLymphoma, FollicularLymphoma, Mantle-CellMelanomaNeuroblastomaCarcinoma, Non-Small-Cell LungPancreatic NeoplasmsRectal NeoplasmsCarcinoma, Renal CellSmall Cell Lung CarcinomaSquamous Cell Carcinoma of Head and NeckUrethral NeoplasmsMultiple MyelomaSalivary Gland NeoplasmsLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellGliosarcoma

Interventions

DocetaxelThalidomide

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCerebral Ventricle NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, Vascular TissueMeningeal NeoplasmsCecal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesCecal DiseasesIntestinal DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsNeoplasms, Bone TissueLymphoma, B-CellLymphomaLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEpstein-Barr Virus InfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaHematologic DiseasesAdenocarcinomaCarcinomaLiver NeoplasmsLiver DiseasesColorectal NeoplasmsAnus DiseasesRectal DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesColonic DiseasesHead and Neck NeoplasmsEsophageal DiseasesOlfactory Nerve DiseasesCranial Nerve DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesStomach DiseasesNeuroendocrine TumorsNevi and MelanomasSkin NeoplasmsCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesKidney NeoplasmsKidney DiseasesCarcinoma, Squamous CellUrethral DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Scot C. Remick, MD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2002

First Posted

January 27, 2003

Study Start

July 1, 2002

Primary Completion

December 1, 2004

Study Completion

January 1, 2006

Last Updated

June 11, 2010

Record last verified: 2010-06

Locations

US(1)