Study of Cetuximab With and Without Weekly Paclitaxel for Patients With Previously Treated Advanced Urothelial Cancer
14. februar 2017 opdateret af: Fox Chase Cancer Center
Randomized Phase II Trial of Cetuximab With and Without Weekly Paclitaxel in Patients With Previously Treated Advanced Urothelial Cancer
The purpose of this research study is to determine whether the investigational drug cetuximab, (Erbitux) alone or with paclitaxel (Taxol) can stabilize the growth of urothelial cancer.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This research study is being done to find out if cetuximab, alone or with paclitaxel will slow the growth of urothelial cancers. Cetuximab is an antibody that blocks a protein called epidermal growth factor receptor (EGFR). EGFR sits on the outside of tumor cells and controls tumor cell growth. This agent has been looked at alone and with other chemotherapy drugs including paclitaxel. It has been found to be safe and can shrink other types of cancer.
This research study is also being done to find out if cetuximab, alone or with paclitaxel shrinks urothelial tumors. If it extends the time the tumors shrink. If it helps people live longer.
The purpose of this research study is to find out what effects (good and bad) these treatments have on you and your cancer. We do not know if you will benefit from this research study. It is possible that your condition will get better, but it is also possible that there will be no effect on your condition or that your condition will get worse. We can use what we learn from this research study to help other people with the same disease.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
41
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19111
- Fox Chase Cancer Center
-
-
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
Alle
Beskrivelse
Inclusion Criteria:
- Histologically confirmed carcinoma of the urothelium (bladder,renal pelvis, ureter)
- Measurable disease by RECIST
- Patients who received only one prior systemic non-taxane regimen for urothelial cancer. May have received this in the adjuvant or neoadjuvant setting or for advanced disease.
- Signed IRB approved consent
- Must have tissue available for EGFR assessment and additional correlative studies
- ECOG PS 0-2
- 18 years of age or older
- Not of child bearing potential or negative pregnancy test within 7 days of treatment
- ANC greater than or equal to 1,500/ul
- Platelets greater than or equal to 100,00/ul
- Creatinine less than or equal to 2x institutional ULN or create. clearance greater than or equal to 30, bilirubin less than or equal to 1.5x ULN, AST&ALT less than or equal to 5x ULN
Exclusion Criteria:
- Received more than one prior regimen for advanced disease
- Prior radiation to more than 30% of marrow containing skeleton
- Prior therapy that specifically and directly targets the EGFR pathway
- Prior severe infusion reaction to a monoclonal antibody, pre-existing neuropathy greater than or equal to grade 2
- Prior reaction to Cremophor EL
- Known acute hepatitis B or C or known HIV
- Active or uncontrolled infection
- Significant history of uncontrolled cardiac disease
- Any concurrent chemotherapy not indicated in this study; or
- Any other investigational agents
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Cetuximab alone
Cetuximab 250mg/m2 IV weekly during each 28 day cycle.
Arm A closed to accrual June 11, 2009 for lack of efficacy
|
Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
|
|
Andet: Cetuximab with Paclitaxel
Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle.
Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
|
Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
Paclitaxel 80mg/m2 IV weekly for each 28 day cycle.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Progression Free Survival
Tidsramme: Measures by CT scans following each 2 cycles of treatment and about every 8 weeks after off treatment for disease progression. Follow up for survival until time of death.
|
Measures by CT scans following each 2 cycles of treatment and about every 8 weeks after off treatment for disease progression. Follow up for survival until time of death.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Response Rate, Duration of Response, Time to Progression Will be Assessed With Radiographic Imaging
Tidsramme: Measured by CT scans after every 2 cycles of treatment (about every 8 weeks)
|
Measured by CT scans after every 2 cycles of treatment (about every 8 weeks)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Yu-Ning Wong, MD, Fox Chase Cancer Center
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.
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 2006
Primær færdiggørelse (Faktiske)
1. juli 2010
Studieafslutning (Faktiske)
1. september 2012
Datoer for studieregistrering
Først indsendt
7. juli 2006
Først indsendt, der opfyldte QC-kriterier
7. juli 2006
Først opslået (Skøn)
10. juli 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
31. marts 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. februar 2017
Sidst verificeret
1. februar 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Urologiske neoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Antineoplastiske midler, immunologiske
- Paclitaxel
- Cetuximab
Andre undersøgelses-id-numre
- FER-GU-004
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 .