Combination Chemotherapy for Metastatic Breast Cancer
9. november 2009 opdateret af: 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
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
70
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Moscow, Den Russiske Føderation, 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
-
-
-
-
-
Munich, Tyskland, 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
-
-
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 til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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.
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: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Gemcitabine + Cisplatin
|
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).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Tumor Response
Tidsramme: 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.)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Duration of Response
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline through eight 21-day cycles
|
Baseline through eight 21-day cycles
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: 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
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. oktober 2002
Studieafslutning (Faktiske)
1. oktober 2007
Datoer for studieregistrering
Først indsendt
12. september 2005
Først indsendt, der opfyldte QC-kriterier
12. september 2005
Først opslået (Skøn)
19. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
11. november 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. november 2009
Sidst verificeret
1. november 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Neoplasmer
- Neoplasmer efter sted
- Brystsygdomme
- Brystneoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gemcitabin
Andre undersøgelses-id-numre
- 7311 (CTEP)
- B9E-VI-S326
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 .