Combination Chemotherapy for Metastatic Breast Cancer
9. November 2009 aktualisiert von: 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
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
70
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Munich, Deutschland, 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
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Moscow, Russische Föderation, 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
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Gemcitabine + Cisplatin
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Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Objective Tumor Response
Zeitfenster: 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.)
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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.
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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.)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Duration of Response
Zeitfenster: 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.)
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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.
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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.)
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Time to Progressive Disease
Zeitfenster: 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.)
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Defined as the time from study enrollment to the first date of disease progression.
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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.)
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Time to Treatment Failure
Zeitfenster: 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.)
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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.
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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.)
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Survival Time
Zeitfenster: 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.)
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Overall survival is the duration from enrollment to death due to any cause.
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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.)
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Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination
Zeitfenster: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
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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).
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Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
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Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades
Zeitfenster: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
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Maximum CTC-NCI toxicity grade for hematology.
Grades range from 0 (none) to 5 (death).
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Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)
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Number of Deaths
Zeitfenster: 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.)
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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.)
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Number of Participants With Adverse Events Leading to Discontinuation
Zeitfenster: Baseline through eight 21-day cycles
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Baseline through eight 21-day cycles
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: 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
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Oktober 2002
Studienabschluss (Tatsächlich)
1. Oktober 2007
Studienanmeldedaten
Zuerst eingereicht
12. September 2005
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. September 2005
Zuerst gepostet (Schätzen)
19. September 2005
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
11. November 2009
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. November 2009
Zuletzt verifiziert
1. November 2009
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Hautkrankheiten
- Neubildungen
- Neubildungen nach Standort
- Brusterkrankungen
- Neoplasien der Brust
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Enzym-Inhibitoren
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Gemcitabin
Andere Studien-ID-Nummern
- 7311 (CTEP)
- B9E-VI-S326
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