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Combination Chemotherapy for Metastatic Breast Cancer

9 november 2009 bijgewerkt door: Eli Lilly and Company

Phase II Study of Gemcitabine Plus Cisplatin as First-line Treatment of Metastatic Breast Cancer

The purpose of this study is to determine the objective tumor response of the first-line therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

70

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

  • Duitsland
      • Munich, Duitsland, 81377
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9AM to 5PM Eastern time (UTC/ GMT - 5hours, EST), or speak with your personal physician
  • Russische Federatie
      • Moscow, Russische Federatie, 115478
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon- Fri from 9AM to 5PM Eastern time (UTC/ GMT - 5hours, EST), or speak with your personal physician

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 tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

  • You are female in the age of 18 to 75 years old.
  • You have been diagnosed with the metastatic breast cancer.
  • You have desire and an opportunity to visit your doctor in medical site, both during realization of the active treatment program, and within 24 months of medical follow up.
  • You must sign this informed consent form

Exclusion Criteria:

  • You are pregnant or breastfeeding.
  • Your laboratory parameters fall outside the limits, admitted by requirements of the present clinical study.
  • You have been diagnosed with serious concomitant or acute infectious disease.
  • You have used experimental medications within the last month.

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: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Gemcitabine + Cisplatin
Geneesmiddel: Gemcitabine
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Geneesmiddel: cisplatin
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective Tumor Response
Tijdsspanne: baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)
Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Duration of Response
Tijdsspanne: first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
first documented complete or partial response to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
Time to Progressive Disease
Tijdsspanne: first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
Defined as the time from study enrollment to the first date of disease progression.
first active treatment dose to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
Time to Treatment Failure
Tijdsspanne: first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment.
first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
Survival Time
Tijdsspanne: first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
Overall survival is the duration from enrollment to death due to any cause.
first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Tijdsspanne: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
The CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).
Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
Tijdsspanne: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
Maximum CTC-NCI toxicity grade for hematology. Grades range from 0 (none) to 5 (death).
Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
Number of Deaths
Tijdsspanne: Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.)
Number of Participants With Adverse Events Leading to Discontinuation
Tijdsspanne: Baseline through eight 21-day cycles
Baseline through eight 21-day cycles

Medewerkers en onderzoekers

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

Sponsor

Eli Lilly and Company

Onderzoekers

  • Studie directeur: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST),, Eli Lilly and Company

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 oktober 2002

Studie voltooiing (Werkelijk)

1 oktober 2007

Studieregistratiedata

Eerst ingediend

12 september 2005

Eerst ingediend dat voldeed aan de QC-criteria

12 september 2005

Eerst geplaatst (Schatting)

19 september 2005

Updates van studierecords

Laatste update geplaatst (Schatting)

11 november 2009

Laatste update ingediend die voldeed aan QC-criteria

9 november 2009

Laatst geverifieerd

1 november 2009

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 7311 (CTEP)
  • B9E-VI-S326

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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