- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00027690
Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer
A Phase II Trial of ZD 1839 (IRESSA) (NSC #715055) in the Treatment of Persistent or Recurrent Endometrial Carcinoma
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
I. Determine the 6-month progression-free survival of patients with persistent or recurrent endometrial carcinoma after receiving gefitinib.
II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the progression-free and overall survival of patients treated with this drug.
IV. Determine the effects of this drug on the levels of epidermal growth factor receptors (EGFR), c-ErbB2 (HER-2/neu) receptors, estrogen receptors (ER), and progesterone receptors (PR) (both PR and PRB) in tumor specimens of these patients.
V. Determine if an association exists between the levels of EGFR, ER, PR, PRB, and HER-2/neu serum concentrations of gefitinib, gefitinib activity, and soluble EGFR and clinical outcome in patients treated with this drug.
VI. Determine the frequency of clinical response (partial and complete response) in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 2.5-6 years.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19103
- Gynecologic Oncology Group
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Histologically confirmed primary endometrial carcinoma
- Recurrent or persistent disease
Received 1 prior chemotherapy regimen for endometrial carcinoma
- Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or nonsurgical assessment
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques (including palpation, plain x-ray, CT scan, and MRI)
- At least 10 mm by spiral CT scan
- Must have at least 1 target lesion for response assessment
Tumors within a previously irradiated field are designated as non-target lesions
- Disease in a previously irradiated field as the only site of measurable disease is allowed only if there has been clear progression of the lesion since the completion of radiotherapy
- Must have a tumor that is accessible for guided core needle or fine needle biopsy
- Ineligible for a higher priority GOG protocol, defined as any active phase III protocol for the same patient population, if one exists
- Performance status - GOG 0-2 (for patients who received 1 prior regimen)
- Performance status - GOG 0-1 (for patients who received 2 prior regimens)
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
- Creatinine no greater than 1.5 times ULN
- No unstable cardiac disease or myocardial infarction within the past 6 months
- History of coronary artery disease, congestive heart failure, or dysrhythmia allowed if on a stable regimen for at least 3 months
- No active infection requiring antibiotics
- No active corneal disease (e.g., keratoconjunctivitis)
- No grade 2 or greater sensory and motor neuropathy
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- No signs or symptoms of bowel dysfunction that would preclude successful ingestion of oral study medication
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- At least 3 weeks since prior immunologic agents directed at malignant tumor
- No concurrent anticancer immunotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy directed at the malignant tumor and recovered
- No prior non-cytotoxic chemotherapy for recurrent or persistent disease
- No concurrent anticancer chemotherapy
- At least 1 week since prior hormonal therapy directed at malignant tumor
- No concurrent anticancer hormonal therapy
- See Disease Characteristics
- At least 3 weeks since prior radiotherapy directed at malignant tumor and recovered
- No concurrent anticancer radiotherapy
- At least 4 weeks since prior surgery except minor procedures using local anesthesia (e.g., placement of a central venous port) and recovered
- At least 3 weeks since any other prior therapy directed at malignant tumor
- One additional prior cytotoxic regimen for recurrent or persistent disease allowed
- No prior gefitinib or other epidermal growth factor receptor inhibitor
- No prior cancer treatment that would contraindicate study therapy
- No concurrent CYP 3A4 inducers (including phenytoin, carbamazepine, barbiturates, nafcillin, rifampin, or Hypericum perforatum [St. John's Wort])
- No other concurrent investigational or antineoplastic agents
- No concurrent chlorpromazine
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Treatment (gefitinib)
Patients receive oral gefitinib once daily on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Korrelative undersøgelser
Given orally
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Andel af patienter i live og progressionsfri
Tidsramme: 6 måneder
|
6 måneder
|
Frequency and severity of adverse effects as assessed by National Cancer Institute Common Toxicity Criteria (CTC) v2.0
Tidsramme: Up to 5 years
|
Up to 5 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Duration of overall survival
Tidsramme: Up to 5 years
|
Up to 5 years
|
Duration of progression-free survival
Tidsramme: Up to 5 years
|
Up to 5 years
|
Frequency of clinical response utilizing the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Tidsramme: Up to 5 years
|
Up to 5 years
|
Numerical descriptions of serum concentrations of gefitinib, gefitinib activity, and soluble epidermal growth factor receptor (EGFR)
Tidsramme: Baseline to end of course 5
|
Baseline to end of course 5
|
Initial performance status and histological grade
Tidsramme: Baseline to end of course 5
|
Baseline to end of course 5
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kimberly Leslie, Gynecologic Oncology Group
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NCI-2012-02429 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA027469 (U.S. NIH-bevilling/kontrakt)
- CDR0000069057
- GOG-0229C (Anden identifikator: CTEP)
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 Tilbagevendende livmoderkarcinom
-
National Cancer Institute (NCI)SuspenderetLokalt avanceret uterin Corpus Leiomyosarcoma | Metastatisk uterin Corpus Leiomyosarcoma | Stadie III Uterine Corpus Leiomyosarcoma AJCC v8 | Stadie IV Uterine Corpus Leiomyosarcoma AJCC v8 | Uoperabelt uterin Corpus LeiomyosarcomaForenede Stater, Puerto Rico
-
City of Hope Medical CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk Leiomyosarkom | Stadie III Uterine Corpus Leiomyosarcoma AJCC v8 | Stadie IV Uterine Corpus Leiomyosarcoma AJCC v8 | Ikke-operabelt Leiomyosarcoma | Stadie IIIA Uterin Corpus Leiomyosarcoma AJCC v8 | Stadie IIIB Uterin Corpus Leiomyosarcoma AJCC v8 | Stadie IIIC Uterin Corpus Leiomyosarcoma... og andre forholdForenede Stater
-
National Cancer Institute (NCI)NRG OncologyAfsluttetTilbagevendende livmoderkorpussarkom | Uterin Corpus LeiomyosarcomaForenede Stater
-
National Cancer Institute (NCI)NRG OncologyAfsluttetTilbagevendende livmoderkorpussarkom | Uterin Corpus LeiomyosarcomaForenede Stater
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)AfsluttetUterin Corpus Leiomyosarcoma | Stadie I Uterin Sarkom AJCC v7Forenede Stater, Belgien, Frankrig, Spanien, Det Forenede Kongerige, Holland, Norge, Venezuela
-
National Cancer Institute (NCI)Aktiv, ikke rekrutterendeStadie III Uterine Corpus Leiomyosarcoma AJCC v8 | Stadie IV Uterine Corpus Leiomyosarcoma AJCC v8 | Uterin Corpus LeiomyosarcomaForenede Stater
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)AfsluttetTilbagevendende livmoderkorpussarkom | Uterin Corpus LeiomyosarcomaForenede Stater
-
National Cancer Institute (NCI)Gynecologic Oncology GroupAfsluttetTilbagevendende livmoderkorpussarkom | Uterin Corpus LeiomyosarcomaForenede Stater
-
Albert Einstein College of MedicineNational Cancer Institute (NCI)AfsluttetUterin Corpus Leiomyosarcoma | Stadie IIA uterin sarkom | Stadie IIB uterin sarkom | Stadium IIIA Uterin Sarkom | Stadium IIIB Uterin Sarkom | Stadie IIIC Uterin Sarkom | Stadium IVA livmodersarkom | Stadium IVB livmodersarkom | Stadium IA uterin sarkom | Stadium IB uterin sarkom | Stadium IC Uterin SarkomForenede Stater
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)RekrutteringLokalt avanceret leiomyosarkom | Metastatisk Leiomyosarkom | Stadie III Uterine Corpus Leiomyosarcoma AJCC v8 | Stadie IV Uterine Corpus Leiomyosarcoma AJCC v8 | Ikke-operabelt Leiomyosarcoma | Uterin Corpus LeiomyosarcomaForenede Stater
Kliniske forsøg med Laboratoriebiomarkøranalyse
-
Liao Jian AnRekrutteringHoved- og halskræftTaiwan
-
Fondation LenvalTrukket tilbage
-
Progenity, Inc.AfsluttetDowns syndrom | Aneuploidi | DiGeorges syndrom | Turners syndrom | Klinefelters syndrom | Kromosom sletning | Edwards syndrom | Patau syndromForenede Stater
-
IRCCS Eugenio MedeaRekrutteringAutismespektrumforstyrrelse | Tidlig indsatsItalien
-
Oregon Health and Science University4DMedicalTilmelding efter invitationLungesygdomme | KOL | Luftvejssygdom | DyspnøForenede Stater
-
IRCCS Eugenio MedeaRekrutteringCerebral Parese | Erhvervet hjerneskadeItalien
-
Modarres HospitalAfsluttetKomplikationer | Billedstyret biopsi | Nyre GlomerulusIran, Islamisk Republik
-
Healthy.io Ltd.Afsluttet
-
Medwave Estudios LimitadaAsociación Chilena de SeguridadUkendtErhvervsmæssig eksponering | Muskuloskeletal sygdomChile
-
Duke UniversityTrukket tilbageAntikoagulation og trombose Point of Care Test (AT-POCT)Forenede Stater