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

8 december 2015 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

170

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: 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.
Geneesmiddel: AMG 479 Placebo
Matching placebo administered Day 1 of each 21 day cycle.
Experimenteel: 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.
Geneesmiddel: AMG 479
Solution for infusion - 18 mg/kg on day 1 of each 21-day cycle

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression Free Survival (PFS): Time From Randomization Until Date of Progression or Death.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time To Progression (TTP): Interval From the Date of Randomization to the Date of Disease Progression
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Translational Research in Oncology

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2009

Primaire voltooiing (Werkelijk)

1 september 2013

Studie voltooiing (Werkelijk)

1 november 2014

Studieregistratiedata

Eerst ingediend

17 juli 2008

Eerst ingediend dat voldeed aan de QC-criteria

17 juli 2008

Eerst geplaatst (Schatting)

18 juli 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

12 januari 2016

Laatste update ingediend die voldeed aan QC-criteria

8 december 2015

Laatst geverifieerd

1 december 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TRIO 014

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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