- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00194740
Taxotere Plus Weekly Navelbine and G-CSF: A Study in Stage IV Breast Cancer
3 december 2007 uppdaterad av: University of Washington
Taxotere Plus Weekly Navelbine and G-CSF: A Phase II Study in Stage IV Breast Cancer
The two drugs used to treat metastatic breast cancer in this study may perform better when used together than when used separately.
The use of another drug that prevents the most common side effect of the two-drug combination permits the delivery of both agents at closer to the "full" dose for either when used alone.
We hypothesize that the two-drug combination used with G-CSF support will be more effective and less toxic than other standard regimens for the treatment of metastatic breast cancer.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Preclinical data suggest that there may be synergy between vinorelbine and paclitaxel when the two drugs are used in combination such that the effect of the two together may be better than either alone.
Clinical data suggest that the use of concurrent G-CSF with paclitaxel and vinorelbine permits the delivery of both agents at approximately 70% of the "full" dose for either, used alone without G-CSF support, with myelosuppression as the usual dose-limiting toxicity and no unusual or unexpected complications.
Encouragingly, 8/20 (40%) patients had objective responses, with three complete remissions (15%) in this program of third-line therapy.
Therefore, we now propose to combine docetaxel at about 70% of "full" dose with vinorelbine at 27.5 mg/m2, the "phase II" dose defined in the previous trial.
Docetaxel will be given on day 1 followed by vinorelbine on days 8 and 15, with G-CSF to be administered on all days except that of docetaxel administration.
The cycle is to be repeated every three weeks.
Studietyp
Interventionell
Inskrivning (Faktisk)
48
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98109-1023
- University of Washington/Seattle Cancer Care Alliance
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Patients must have stage IV, microscopically-confirmed carcinoma of the breast with histologic slides and/or blocks available for review.
- Patients must have relapse or progression while receiving, or within 12 months of having received, anthracycline-containing (doxorubicin or mitoxantrone) regimen as either adjuvant treatment or therapy for advanced breast cancer. Prior Taxol by 3- or 24-hour infusion is permitted. Patients who have received a maximum dose of anthracycline (greater than 450 mg/m2) are also eligible.
- Patients must have measurable (bidimensionally) or evaluable disease.
- Patients must be 18 or more years of age.
- Patients must have a Karnofsky Performance Status greater than or equal to 70% at screen and on the first day of treatment.
- Patients must have a life expectancy of more than 16 weeks.
- Prior irradiation is permitted, provided that prior irradiation does not exceed 25% of the estimated bone marrow volume and provided that measurable/evaluable disease exists outside the radiation field OR there must be histologic proof of progressive disease within a radiation field.
- Informed consent must be obtained prior to registration.
- Patients must be more than 2 weeks from prior surgery; more than 3 weeks from radiation therapy to the pelvis, spine or long bones; more than 3 weeks from prior chemotherapy (more than 6 weeks for mitomycin C or nitrosureas), or more than 2 weeks from prior hormonal therapy.
- All patients must have appropriate central venous access.
Exclusion Criteria:
Patients are excludes if their:
- Granulocyte count is less than 1,500/mm3.
- Platelet count is less than 100,000/mm3.
- Hemoglobin is less than 9 gm/dl.
- Creatinine is greater than 2.0 mg/dl.
- Total bilirubin is greater than ULN (institutional upper limit of normal)..
- SGOT (AST) and/or SGPT (ALT) is greater than 1.5 x ULN concomitant with alkaline phosphatase greater than 2.5 x ULN.
Patients are excluded if they are:
- In visceral crisis characterized by rapidly progressive hepatic or lymphangitic lung metastases.
- Medically unstable.
- Pregnant or lactating.
Patients are excluded if they have:
- Uncontrolled CNS disease.
- Pre-existing clinically significant peripheral neuropathy except for abnormalities due to cancer.
- Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol.
- Prior therapy with Navelbine.
- Sensitivity to E. Coli-derived proteins.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 1
|
60 mg/m2, IV, day 1 of each 21 day cycle
Andra namn:
27.5 mg/m2, IV, days 8 & 15 of each 21 day cycle
Andra namn:
5 µg/kg/day s.c., to be administered days 2-21 of each cycle.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Response to treatment
Tidsram: Until disease progression
|
Until disease progression
|
Toxicity of treatment
Tidsram: Until completion of treatment
|
Until completion of treatment
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Time to progression
Tidsram: Until disease progression occurs
|
Until disease progression occurs
|
Over all survival
Tidsram: Until study is closed
|
Until study is closed
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Julie R. Gralow, M.D., University of Washington
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 1997
Avslutad studie (Faktisk)
1 juni 2007
Studieregistreringsdatum
Först inskickad
14 september 2005
Först inskickad som uppfyllde QC-kriterierna
14 september 2005
Första postat (Uppskatta)
19 september 2005
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
6 december 2007
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 december 2007
Senast verifierad
1 december 2007
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 97-5372-A
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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