- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00003669
Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer
Phase II Nonrandomized Study of LY353381-HC1 in Patients With Recurrent or Advanced Endometrial Cancer
RATIONALE: Estrogen can stimulate the growth of endometrial cancer cells. Hormone therapy using arzoxifene hydrochloride may fight the endometrial cancer by blocking the use of estrogen by the tumor cells
PURPOSE: This phase II trial is studying how well arzoxifene hydrochloride works in treating women with recurrent, advanced, or metastatic endometrial cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES: I. Determine the objective tumor response rate (complete response and partial response) to arzoxifene hydrochloride in patients with recurrent or advanced endometrial cancer. II. Determine the time to progressive disease, time to treatment failure, response duration, and survival in patients with recurrent or advanced endometrial cancer receiving arzoxifene hydrochloride. III. Assess the safety of this treatment in these patients. IV. Measure changes in serum estradiol, follicle stimulating hormone, luteinizing hormone, and sex hormone binding globulin during this treatment in these patients.
OUTLINE: Patients receive oral arzoxifene hydrochloride daily at a fixed dose. Treatment continues in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: Not specified
National Cancer Institute (NCI) registered this trial with Eli Lilly as sponsor. NCI did not update the record when the trial completed. In June 2012, NCI transferred the trial to Lilly's clinicaltrials.gov account and Lilly updated the record with the trial completion date. This trial is not an applicable trial under Food and Drug Administration Amendments Act of 2007 (FDAAA).
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Pasadena, California, Estados Unidos, 91109-7013
- Huntington Memorial Hospital
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Missouri
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Columbia, Missouri, Estados Unidos, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University Barnard Cancer Center
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New York
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Columbus, Ohio, Estados Unidos, 43214
- Grant/Riverside Methodist Hospitals
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73190
- University of Oklahoma Health Sciences Center
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Pennsylvania
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Abington, Pennsylvania, Estados Unidos, 19001
- Abington Memorial Hospital
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Texas
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Houston, Texas, Estados Unidos, 77060
- U.S. Oncology
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS: Histologically confirmed recurrent, advanced, or metastatic endometrial cancer not amenable to curative surgery or radiotherapy Patients should have previously undergone radical surgery (minimum of total abdominal hysterectomy and bisalpingoophorectomy), radical radiotherapy, or not be candidate for such procedures Bidimensionally measurable disease by x-ray, CT scan, MRI, or physical exam No papillary serous or clear cell carcinomas of the endometrium Hormone receptor status: Estrogen receptor positive and/or progesterone receptor positive Unknown receptor status patients allowed provided (1) original tumor was well- or moderately-well differentiated (2) had endometrioid histology
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Menopausal status: Not specified Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL (transfusion-independent) Prothrombin time or activated partial thromboplastin time no greater than 1.25 times upper limit of normal (ULN) Hepatic: Bilirubin no greater than 1.5 times normal ALT or AST no greater than 2.5 times ULN (ALT and AST no greater than 5 times ULN in the presence of liver metastases) Renal: Creatinine no greater than 1.5 ULN Other: No other primary malignancy within the past 5 years except adequately treated nonmelanomatous cancer of the skin or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for recurrent or metastatic endometrial cancer At least 1 year since prior adjuvant chemotherapy Endocrine therapy: No prior antiestrogen therapy for any stage of endometrial cancer At least 12 months from time of diagnosis since prior raloxifene Prior progesterone treatment allowed Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2141
- LILLY-H4Z-MC-JWWI
- MSKCC-99001
- CDR0000066766
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Cáncer endometrial
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University of Southern CaliforniaNational Cancer Institute (NCI)RetiradoHiperplasia endometrial atípica | Carcinoma endometrial recidivante | Adenocarcinoma endometrial | Carcinoma endometrial en estadio IA | Carcinoma endometrial en estadio IB | Carcinoma endometrial en estadio II | Carcinoma endometrial en estadio IIIA | Carcinoma endometrial en estadio IIIB | Carcinoma... y otras condiciones
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IVI MadridIgenomixTerminado
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University Magna GraeciaDesconocidoTrastorno endometrial | Endometrio delgado | Espesor endometrial que no crece bajo estimulación con estrógenosItalia
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Fundación IVIInstituto Valenciano de Infertilidad, IVI VALENCIAReclutamiento
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IgenomixTerminadoReceptividad EndometrialEspaña, Bélgica, Brasil, Bulgaria, Japón, Panamá, Pavo
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Sohag UniversityAún no reclutandoCáncer endometrial e hiperplasia endometrialEgipto
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Case Comprehensive Cancer CenterTerminadoCarcinoma endometrial en estadio IV | Carcinoma endometrial en estadio III | Carcinoma endometrial en estadio II | Carcinoma endometrial en estadio IEstados Unidos
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Carmel Medical CenterTerminadoCarcinoma Endometrial EndometrialIsrael
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Odense University HospitalActivo, no reclutandoReceptividad EndometrialDinamarca
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ART Fertility Clinics LLCTerminadoReceptividad EndometrialEmiratos Árabes Unidos