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Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer

8 de diciembre de 2015 actualizado por: Translational Research in Oncology

A Randomized, Double-blind, Placebo Controlled, Multi-center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer

This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

170

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 12200
        • Charite Campus Benjamin Franklin
      • Berlin, Alemania, 13353
        • University Hospital Charité
      • Bonn, Alemania, 53105
        • Universitat Bonn
      • Erlangen, Alemania, 91054
        • Universitätsklinikum Erlangen
      • Hamburg, Alemania, 20246
        • Universitatsklinikum Hamburg Eppendorf
      • Homburg, Alemania, 66421
        • Universitatsklinikum des Saarlandes
      • Kassel, Alemania, 34125
        • Klinikum Kassel
      • Munich, Alemania, 80637
        • Rotkreuzkrankenhaus Munchen
      • Tubingen, Alemania, 72076
        • Universitats Frauenklinik Tubingen
  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G1Z2
        • Cross Cancer Institute
    • Ontario
      • London, Ontario, Canadá, N6A4L6
        • London Health Science Center
    • Quebec
      • Montreal, Quebec, Canadá, H3T1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canadá, H2L4M1
        • Chum Hopital Notre Dame
  • España
      • Barcelona, España, 08036
        • Hospital Clinic I Provincial
      • Guadalajara, España, 19002
        • Hospital Universitario de Guadalajara
      • La Laguna, España, 38320
        • Hospital Universitario de Tenerife
      • Madrid, España, 28041
        • Hospital U 12 de Octubre
      • Sevilla, España, 341071
        • Hospital Universitario Virgen Macarena de Sevilla
  • Estados Unidos
    • California
      • Alhambra, California, Estados Unidos, 91801
        • Central Hematology Oncology Medical Group Inc.
      • Burbank, California, Estados Unidos, 91505
        • Providence Saint Joseph Medical Center
      • Fullerton, California, Estados Unidos, 92835
        • St Jude Heritage Healthcare
      • La Verne, California, Estados Unidos, 91750
        • Wilshire Oncology Medical Group Inc
      • Los Angeles, California, Estados Unidos, 90033
        • University of Southern California
      • Los Angeles, California, Estados Unidos, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, Estados Unidos, 90095-1678
        • UCLA
      • Northridge, California, Estados Unidos, 91325
        • North Valley Hematology/Oncology Medical Group
      • Oxnard, California, Estados Unidos, 93030
        • Ventura County Hematology-Oncology Specialists
      • San Francisco, California, Estados Unidos, 94115
        • University of California San Francisco
      • santa Maria, California, Estados Unidos, 93454
        • Central Coast Medical Oncology Corporation
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06510
        • Yale University School Of Medicine
    • Florida
      • Hollywood, Florida, Estados Unidos, 33021
        • Memorial Cancer Institute
      • Orlando, Florida, Estados Unidos, 32804
        • Florida Hospital Cancer Institute
      • Tampa, Florida, Estados Unidos, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Winship Cancer Institute Emory University School of Medicine
    • Louisiana
      • Metairie, Louisiana, Estados Unidos, 70006
        • Hematology And Oncology Specialists, Llc
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic
    • Nevada
      • Henderson, Nevada, Estados Unidos, 89052
        • Comprehensive Cancer Centers of Nevada
    • North Carolina
      • Asheville, North Carolina, Estados Unidos, 28806
        • Hope A Women's Cancer Center
      • Winston-Salem, North Carolina, Estados Unidos, 27104
        • Wake Forest University Baptist Medical Center
    • Ohio
      • Toledo, Ohio, Estados Unidos, 43614
        • University of Toledo
      • Toledo, Ohio, Estados Unidos, 43606
        • The Toledo Hospital
  • Francia
      • La Roche Sur Yon, Francia, 85925
        • Centre Hospitalier Departemental Les Oudairies
      • Lyon, Francia, 69373
        • Centre Léon Bérard
      • Neuilly Sur Seine, Francia, 92200
        • Clinique Hartmann
      • Paris, Francia, 75005
        • Institut Curie
  • Irlanda
      • Dublin, Irlanda
        • St Jame's Hospital
      • Waterford, Irlanda
        • Waterford Regional Hospital
  • Israel
      • Kfar-Saba, Israel, 44281
        • Meir Medical Center
      • Ramat Gan, Israel, 52621
        • Sheba medical center
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel, 64239
        • Sourasky Medical Center
      • Zrifin, Israel, 70300
        • Asaf Harofe MC
  • Reino Unido
      • Leeds, Reino Unido, LS97TF
        • Saint James's University Hospital
      • London, Reino Unido, W1T4TJ
        • University College London
      • Northwood, Reino Unido, HA62RN
        • Mount Vernon Cancer Centre

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Histologically-confirmed optimally debulked (< 1 cm) FIGO stage III or stage IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
  • Patients should have undergone surgical debulking, by a surgeon experienced in the management of ovarian cancer, with the aim of maximal surgical cytoreduction. All patients must be optimally debulked as defined as having no residual tumor of greater than 1 cm in the post surgical setting.
  • Patients with stage IV disease will be eligible if a positive pleural cytology is the only extra peritoneal disease.
  • Paraffin block (or 10 - 20 unstained slides) and fresh frozen surgical/biopsy specimens of the primary tumor are required at baseline.
  • No prior systemic treatment in the primary disease treatment setting.
  • Female ≥ 18 years of age or legal age.
  • ECOG performance status ≤ 2.
  • Adequate organ and bone marrow function

  • Non diabetic patients or Type 1 or 2 Diabetic Patients:

    • Diabetes must be controlled with HgbA1c < 8% and fasting blood glucose level <160 mg/dL.

  • Patient must be willing and able to comply with scheduled visits, and all study procedures.
  • Informed consent obtained.
  • Patients should be able to commence systemic therapy within 6 weeks of cytoreductive surgery.
  • Life expectancy > 12 weeks.
  • Adequate coagulation parameters (within 14 days prior to randomization), International Normalized Ratio (INR) ≤1.5; Activated Prothrombin Time (APTT) ≤ 1.5 x ULN

Exclusion Criteria:

  • Non-epithelial ovarian cancer, including malignant mixed Mullerian tumors.
  • Borderline tumors (tumors of low malignant potential).
  • Planned intraperitoneal cytotoxic chemotherapy.
  • Prior systemic anticancer therapy for ovarian cancer.
  • Any previous radiotherapy to the abdomen or pelvis.
  • Patients with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless ALL of the following criteria for describing the endometrial carcinoma are met: Stage ≤ Ib, no more than superficial myometrial invasion, no lymphovascular invasion, not poorly differentiated (i.e., not Grade 3 or papillary serous or clear cell).
  • Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri or curatively treated DCIS/LCIS, or non-melanoma or in situ melanoma skin cancer.
  • Prior treatment with a humanized monoclonal antibody anticancer therapeutic.
  • Prior treatment with investigational treatment targeted to IGF axis including, but not limited to, CP 751,871, IM-A12, RO4858696.
  • Previous exposure to AMG 479.
  • Anticipation of a need for a major surgical procedure or radiation therapy during the study.
  • History of hypersensitivity to recombinant proteins.
  • Treatment with radiotherapy, surgery, or an investigational agent within 4 weeks of randomization.
  • Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, grade > 2 peripheral neuropathy, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
  • History of brain metastases, spinal cord compression, or carcinomatous meningitis.
  • Patient of child-bearing potential is pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding.
  • Patient of child-bearing potential is not willing to use adequate contraceptive precautions.
  • Known active infection, or on antiretroviral therapy for HIV disease.
  • Known positive test for chronic hepatitis B or C infection.
  • Any other underlying physical or mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
  • Refusal or inability to give informed consent to participate in the study.
  • Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: A
Placebo plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of placebo administered on Day 1 of each 21-day cycle.
Droga: AMG 479 Placebo
Matching placebo administered Day 1 of each 21 day cycle.
Experimental: B
AMG 479 plus paclitaxel/carboplatin chemotherapy administered on Day 1 of each 21-day cycle for 6 cycles - then 6 additional cycles of AMG 479 single agent administered on Day 1 of each 21-day cycle.
Droga: AMG 479
Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.
Periodo de tiempo: Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle

A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:

  • Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR
  • Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR
  • CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart
Radiological tumor assessment: every 12(+/- 1) weeks for 3 years after randomization + CA 125: day 1 of each cycle

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression
Periodo de tiempo: Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle

A patient may have been declared to have progressive disease on the basis of radiological measuremt of tumor lesions assessmt or CA125 evaluation (tumor measuremts taking precedence).Radiological progression was defined as per the RECIST guidelines (Therasse et al, JNCI2000) as at least 20% increase in the sum of the longest diameters of target lesions(ref the smallest sum of the longest diam recorded since the treatmt started or since the appearance of at least 1 new lesion).Serum CA125 progression was defined, according to the 2005 GCIG def: pts with:

  • Elevated CA125 pretreatmt and normalization of CA125 has to show evidence of CA125≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart OR
  • Elevated CA125 pretreatmt which never normalized must show evidence of CA125≥ 2 times the nadir value on 2 occasions at least 1 wk apart OR
  • CA125 in the normal range pretreatmt had to show evidence of CA125 ≥ 2 times the upper normal limit on 2 occasions at least 1 wk apart
Radiological tumor assessment: every 12 (+/- 1) weeks for 3 years after randomization + CA125: day 1 of each cycle
Overall Survival (OS)
Periodo de tiempo: Day 1 of each cycle up to 4 years after randomization
Interval between the date from randomization to death from any cause whichever came first.
Day 1 of each cycle up to 4 years after randomization

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Translational Research in Oncology

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2009

Finalización primaria (Actual)

1 de septiembre de 2013

Finalización del estudio (Actual)

1 de noviembre de 2014

Fechas de registro del estudio

Enviado por primera vez

17 de julio de 2008

Primero enviado que cumplió con los criterios de control de calidad

17 de julio de 2008

Publicado por primera vez (Estimar)

18 de julio de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

12 de enero de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

8 de diciembre de 2015

Última verificación

1 de diciembre de 2015

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • TRIO 014

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. .

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