- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00003821
Aminopterin in Treating Patients With Recurrent or Refractory Endometrial Cancer
Phase II Trial of Aminopterin in Patients With Persistent or Recurrent Endometrial Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of aminopterin in treating patients who have refractory or recurrent endometrial cancer.
Studieoversigt
Detaljeret beskrivelse
OBJECTIVES: I. Estimate the antitumor activity of aminopterin in patients with persistent, recurrent, or refractory endometrial carcinoma who have failed prior first line cytotoxic chemotherapy. II. Determine the quantitative and qualitative toxic effects of aminopterin in this patient population. III. Determine the overall patient survival and time to progression of these patients. IV. Assess the pharmacokinetic profile of these patients.
OUTLINE: Patients receive oral aminopterin every 12 hours twice weekly. Treatment continues for up to 15 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
Undersøgelsestype
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Missouri
-
Saint Louis, Missouri, Forenede Stater, 63110
- Division of Gynecologic Oncology
-
-
North Carolina
-
Greenville, North Carolina, Forenede Stater, 27858-4354
- East Carolina University School of Medicine
-
-
Ohio
-
Akron, Ohio, Forenede Stater, 44302
- Gynecologic Oncologists of NE Ohio
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75235-9154
- Simmons Cancer Center - Dallas
-
Dallas, Texas, Forenede Stater, 75246
- Texas Oncology, P.A.
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Comprehensive Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS: Histologically confirmed persistent, recurrent, or refractory endometrial carcinoma who have failed prior first line chemotherapy Bidimensionally measurable disease by physical exam or medical imaging techniques (sonography acceptable if lesion(s) are clearly defined and measurable in two dimensions) Ascites and pleural effusions are not measurable
PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: At least 2 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant infection
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: At least 4 weeks since prior surgery and recovered Other: At least 4 weeks since any prior therapy directed at malignant endometrial tumor(s) At least 4 weeks since prior folate-containing vitamins No concurrent folate-containing vitamins No other concurrent anticancer therapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000066974
- ILEX-AMT221-A1
- ILEX-AMT221
- NCI-V99-1531
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Endometriecancer
-
IVI MadridIgenomixAfsluttet
-
Reproductive Medicine Associates of New JerseyAfsluttetEndometrial dysfunktionForenede Stater
-
Mỹ Đức HospitalRekrutteringBørns udvikling | Endometrial forberedelseVietnam
-
National Cancer Institute (NCI)AfsluttetLunge | Hjerne | Bryst | Prostata | EndometrialForenede Stater
-
farzaneh hojjatRazieh dehghani firouzabadi; Robab davarAfsluttetOverførsel af frossen embryo | Endometrial forberedelseIran, Islamisk Republik
-
Catalysis SLAfsluttetCervikal karcinom stadie II | Cervikal karcinom stadie III | Cervikal karcinom stadie IV | Endometrial Adenocarcinom Stadium II | Endometrial Adenocarcinom Stadium III | Endometrial Adenocarcinom Stadium IVCuba
-
Eli Lilly and CompanyAfsluttetVasomotoriske symptomer | Endometrial sikkerhedForenede Stater
-
New Valley UniversityAfsluttetProgesteron primet endometrial protokol | Gonadotropinfrigørende hormonantagonistprotokol | Assisterede reproduktive behandlingerEgypten
-
Cairo UniversityUkendtRIF, Endometrial Receptivitet
-
NRG OncologyNational Cancer Institute (NCI); Canadian Cancer Trials GroupSuspenderetStadie I Uterine Corpus Endometrial Stromal Sarkom AJCC v8 | Stadie II Uterine Corpus Endometrial Stromal Sarkom AJCC v8 | Stadie III Uterine Corpus Endometrial Stromal Sarkom AJCC v8Forenede Stater
Kliniske forsøg med aminopterin
-
Syntrix Biosystems, Inc.National Institute of Allergy and Infectious Diseases (NIAID)AfsluttetPsoriasisForenede Stater
-
Syntrix Biosystems, Inc.AfsluttetRheumatoid arthritisUkraine
-
Genzyme, a Sanofi CompanyAfsluttet
-
Syntrix Biosystems, Inc.National Institute of Allergy and Infectious Diseases (NIAID)Afsluttet
-
Spectrum Pharmaceuticals, IncAfsluttetPerifert T-celle lymfomBelgien, Spanien, Forenede Stater, Australien, Frankrig, Israel, Canada, Det Forenede Kongerige, New Zealand, Italien, Irland, Polen, Puerto Rico
-
Acrotech Biopharma Inc.AfsluttetPerifert T-celle lymfomForenede Stater, Det Forenede Kongerige, Canada, Frankrig, Italien, Belgien
-
Acrotech Biopharma Inc.AfsluttetBrystkræft | Brysttumorer | Neoplasmer, bryst | Brystkræft | Humant brystkarcinomFrankrig, Forenede Stater, Tjekkiet, Ungarn
-
Acrotech Biopharma Inc.AfsluttetKutant T-celle lymfomForenede Stater
-
Acrotech Biopharma Inc.AfsluttetCarcinom, overgangscelle | Blærekræft | Blære neoplasmaSpanien, Frankrig, Belgien, Forenede Stater, Argentina, Kroatien
-
Acrotech Biopharma Inc.AfsluttetMycosis Fungoides | Sezary syndrom | Kutant T-celle lymfom | Primært kutan anaplastisk storcellet lymfomForenede Stater, Italien