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Trastuzumab and Erlotinib as First-Line Therapy in Treating Women With Metastatic Breast Cancer Associated With HER2/Neu Overexpression

17. september 2020 opdateret af: Jonsson Comprehensive Cancer Center

Phase I/II Study Of Herceptin Combined With OSI-774 In The First-Line Treatment Of Metastatic Breast Cancer Associated With HER2/Neu Overexpression

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Combining trastuzumab with erlotinib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with HER2/neu overexpression.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Determine the maximum tolerated dose and recommended phase II dose of erlotinib when combined with trastuzumab (Herceptin) as first-line therapy in women with metastatic breast cancer associated with HER2/neu overexpression. (Phase I closed to accrual as of 01/2004)
  • Determine the safety profile of this regimen in these patients.
  • Determine the rate and duration of objective response in patients treated with this regimen.
  • Determine the pharmacologic behavior of this regimen in these patients.
  • Determine time to disease progression and duration of survival in patients treated with this regimen.
  • Correlate the antitumor activity of this regimen with epidermal growth factor receptor expression in these patients.

OUTLINE: This is a dose-escalation study of erlotinib. (Phase I closed to accrual as of 01/2004).

Patients receive oral erlotinib once daily beginning on day 2 and trastuzumab (Herceptin) IV over 30-90 minutes (1-4 hours after erlotinib) once weekly beginning on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the recommended phase II dose.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for the phase I portion (closed to accrual as of 01/2004) and 27-81 patients will be accrued for the phase II portion of this study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

27

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Women aged > 18 years
  • Histologically documents metastatic breast cancer
  • HER2 positive using Fluorescence In Situ Hybridization (FISH)
  • For phase I, patients who have previously received treatment for their metastatic disease are allowed to participate.
  • For the phase II portion of the study, patients must have measureable disease (> 2 cm; > 1 cm on spiral CT scan)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • A life expectancy of > 3 months
  • Use of effective means of contraception

Exclusion Criteria:

  • For Phase II, prior cytotoxic chemotherapy and/or prior Herceptin for their metastatic disease. Prior treatment in the adjuvant setting is allowed.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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
please see intervention description
Biologisk: trastuzumab
Day 1 4mg/kg IV 2 mg/kg IV weekly.
Andre navne:
  • Herceptin
Medicin: erlotinib hydrochloride
100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol.
Andre navne:
  • OSI-774

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart.
Tidsramme: 5 years

Complete Response:

The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.

Partial Response:

A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission.
5 years
Recommended Dose for Phase II
Tidsramme: treatment period
treatment period

Sekundære resultatmål

Resultatmål
Tidsramme
Duration of Objective Response
Tidsramme: 5 years
5 years
Incidence of Adverse Events
Tidsramme: 5 years
5 years
Serum Concentration of Herceptin at Specified Time-points.
Tidsramme: 4 months
4 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jonsson Comprehensive Cancer Center

Samarbejdspartnere

Genentech, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2001

Primær færdiggørelse (Faktiske)

1. december 2011

Studieafslutning (Faktiske)

1. december 2011

Datoer for studieregistrering

Først indsendt

9. april 2002

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2020

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 01-06-020
  • CDR0000069295
  • GENENTECH-OSI2365s
  • NCI-G02-2057

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 .

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