- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00253344
Lenalidomide and Docetaxel in Treating Patients With Advanced Solid Tumors
Phase I Trial of Daily Lenalidomide (CC-5013, Revlimid™) and Docetaxel Given Every Three Weeks in Patients With Advanced Solid Tumors
RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with docetaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when given together with docetaxel in treating patients with advanced solid tumors.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity and maximum tolerated dose of lenalidomide when given in combination with docetaxel in patients with advanced solid tumors.
Secondary
- Determine the safety of this regimen in these patients.
- Determine the objective tumor response in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of lenalidomide.
Patients receive oral lenalidomide on days 1-14 and docetaxel IV over 1 hour on day 1. Courses repeat every 21 days until disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of lenalidomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
-
-
Ohio
-
Cleveland, Ohio, Verenigde Staten, 44106-5065
- Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor
- Advanced disease
- Refractory to standard therapy OR no standard therapy exists
- Measurable or evaluable disease
No active brain metastases
- Previously treated (e.g., surgery or radiotherapy) brain metastases are allowed provided they are currently asymptomatic and inactive by CT scan or MRI
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2
Life expectancy
- At least 4 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8 g/dL
Hepatic
- Bilirubin normal
Meets 1 of the following criteria:
- Alkaline phosphatase (AP) normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST or ALT normal
Renal
- Creatinine ≤ 2 mg/dL
Cardiovascular
- No New York Heart Association class III or IV heart disease
Immunologic
- No prior desquamating rash or ≥ grade 2 allergic reaction while receiving thalidomide
- No history of hypersensitivity to docetaxel or other drugs formulated in polysorbate 80
- No history of allergic reaction to compounds of similar chemical or biologic composition to study drugs
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other uncontrolled illness or other condition that would preclude study compliance
- No peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent hematopoietic growth factors during course 1 of study treatment
- No concurrent immunotherapy
Chemotherapy
At least 6 weeks since prior mitomycin or nitrosoureas
- No more than 2 prior courses of mitomycin
- No other concurrent chemotherapy
Radiotherapy
- No prior pelvic radiotherapy
Other
- At least 4 weeks since prior anticancer therapy
- No concurrent warfarin for anticoagulation (heparin is allowed)
- Recovered from all prior treatment
- No other concurrent anticancer therapy except bisphosphonates
- No other concurrent investigational agents
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Maximum tolerated dose
Tijdsspanne: measured at end of phase I
|
measured at end of phase I
|
Dose-limiting toxicity
Tijdsspanne: measured after every course
|
measured after every course
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Disease response
Tijdsspanne: measured after every 2 courses
|
measured after every 2 courses
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Matthew M. Cooney, MD, Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Antineoplastische middelen
- Immunologische factoren
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Docetaxel
- Lenalidomide
Andere studie-ID-nummers
- CASE2Y04 (Andere identificatie: Case Comprehensive Cancer Center)
- P30CA043703 (Subsidie/contract van de Amerikaanse NIH)
- AVENTIS-CASE-2Y04
- CELGENE-CASE-2Y04
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op docetaxel
-
Nereus Pharmaceuticals, Inc.VoltooidKankerVerenigde Staten, Australië, Indië, Chili, Brazilië, Argentinië
-
Tianjin Medical University Cancer Institute and...Werving
-
Zhuhai Beihai Biotech Co., LtdVoltooidVaste tumoren | Bio-equivalentie | DocetaxelIndië
-
Jiangsu HengRui Medicine Co., Ltd.Shanghai Pulmonary Hospital, Shanghai, ChinaVoltooidNiet-kleincellige longkanker (NSCLC)China
-
Optimal Health ResearchVoltooidBorstkanker | Longkanker | ProstaatkankerVerenigde Staten
-
National Cancer Center, KoreaSeoul National University Bundang Hospital; Gachon University Gil Medical Center en andere medewerkersOnbekend
-
Arog Pharmaceuticals, Inc.IngetrokkenCarcinoom, niet-kleincellige long
-
Australian and New Zealand Urogenital and Prostate...Peter MacCallum Cancer Centre, AustraliaWervingCastratieresistente prostaatkankerAustralië
-
SanofiVoltooid
-
SanofiVoltooidLongneoplasmataFrankrijk, Nederland, Spanje, Kalkoen, België, Finland, Italië, Verenigd Koninkrijk