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

8 dicembre 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

170

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: 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.
Sperimentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Translational Research in Oncology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2009

Completamento primario (Effettivo)

1 settembre 2013

Completamento dello studio (Effettivo)

1 novembre 2014

Date di iscrizione allo studio

Primo inviato

17 luglio 2008

Primo inviato che soddisfa i criteri di controllo qualità

17 luglio 2008

Primo Inserito (Stima)

18 luglio 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

12 gennaio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 dicembre 2015

Ultimo verificato

1 dicembre 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TRIO 014

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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