Combination of Taxotere and Oxaliplatin in Squamous Cell Carcinoma of the Head and Neck
20 maggio 2014 aggiornato da: University of Southern California
Phase II Trial of Taxotere and Oxaliplatin Combination Chemotherapy in Squamous Cell Carcinoma of the Head and Neck
This research study is for subjects with squamous cell cancer of the head and neck which is not solely treatable with surgery or radiation. This research study involves treatment with an experimental chemotherapy combination of oxaliplatin and Taxotere. Tha main purpose of this study is to assess the effectiveness of this combination of medications for this type of cancer.
Approximately 54 subjects will take part in this study.
Panoramica dello studio
Stato
Terminato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
12
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
California
-
Los Angeles, California, Stati Uniti, 90033
- USC/Norris Comprehensive Cancer Center
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed Head and Neck Squamous Cell Carcinoma which is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Tissue from tumor must be available. This may be paraffin embedded tissue from previous biopsy/resection. If it is not available, a repeat biopsy must be performed.
- Age greater than or equal to 18 years
- ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 50%)
- Patients must have adequate organ and marrow function as defined below:
- leukocytes greater than or equal to 3,000/microliter
- hemoglobin greater than or equal to 8.0 g/dl
- absolute neutrophil count greater than or equal to 1,500/microliter
- platelets greater than or equal to 100,000/microliter
- total bilirubin within normal institutional limits
- creatinine within normal institutional limits OR creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
If:
- ALK PHOS is less than or equal to ULN and AST or ALT is less than or equal to ULN, patient is eligible.
- ALK PHOS is less than or equal to ULN and AST or ALT is greater than 1x but less than or equal to 1.5x, patient is eligible.
- ALK PHOS is less than or equal to ULN and AST or ALT is greater than 1.5x but less than or equal to 5x, patient is eligible.
- ALK PHOS is less than or equal to ULN and AST or ALT is greater than 5x ULN, patient is ineligible.
- ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is less than or equal to ULN, patient is eligible.
- ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is greater than 1x but less than or equal to 1.5x, patient is eligible.
- ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is greater than 1.5x but less than or equal to 5x, patient is ineligible.
- ALK PHOS is greater than 1x but less than or equal to 2.5x and AST or ALT is greater than 5x ULN, patient is ineligible.
- ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is less than or equal to ULN,patient is eligible.
- ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is greater than 1x but less than or equal to 1.5x, patient is ineligible.
- ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is greater than 1.5x but less than or equal to 5x, patient is ineligible.
- ALK PHOS is greater than 2.5x but less than or equal to 5x and ALT or AST is greater than 5x ULN, patient is ineligible.
- ALK PHOS is greater than 5x ULN and AST or ALT is less than or equal to ULN, patient is ineligible.
- ALK PHOS is greater than 5x ULN and AST or ALT is greater than 1x but less than or equal to 1.5x, patient is ineligible
- ALK PHOS is greater than 5x ULN and AST or ALT is greater than 1.5x but less than or equal to 5x, patient is ineligible
- ALK PHOS is greater than 5x ULN and AST or ALT is greater than 5x ULN, patient is ineligible
- Patients with neuropathy < 1.
- Ability to understand and the willingness to sign a written informed consent document
- Women of childbearing potential must have a negative pregnancy test
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
- Patients undergoing therapy with other investigational agents.
- Previous treatment involving regimen utilizing any of the protocol chemotherapeutic agents
- Patients with known brain metastases
- History of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy. Patients with a history of severe hypersensitivity reaction to Taxotere or Oxaliplatin or other drugs formulated with polysorbate 80
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia
- Pregnant and nursing women
- HIV-positive patients
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Arm 1
On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2.
Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min.
This treatment regimen will be repeated every 21 days.
|
Taxotere is given at 60 mg/m2 as a 1-hour intravenous infusion.
Oxaliplatin will be administered intravenously over 2 hours at a rate of 10mg/m2/min.
on day 1 every 3 weeks.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Tumor Response
Lasso di tempo: 6 months after the last subject enrolled has gone off study
|
All eligible patients who received the first dose of Taxotere will be included in the analysis. Tumor Response will be categorized as: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Early Death from Malignant Disease. Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least a 30% decrease in the sum of the largest diameter (LD) of target lesions taking as reference the baseline sum LD; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started; PD = at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
6 months after the last subject enrolled has gone off study
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
Lasso di tempo: At end of every cycle
|
Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
At end of every cycle
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Barbara Gitlitz, MD, University of Southern California
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2004
Completamento primario (Effettivo)
1 luglio 2009
Completamento dello studio (Effettivo)
1 luglio 2010
Date di iscrizione allo studio
Primo inviato
12 settembre 2005
Primo inviato che soddisfa i criteri di controllo qualità
12 settembre 2005
Primo Inserito (Stima)
16 settembre 2005
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
22 maggio 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 maggio 2014
Ultimo verificato
1 maggio 2014
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie per sede
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie della testa e del collo
- Neoplasie, cellule squamose
- Carcinoma
- Carcinoma, cellule squamose
- Carcinoma a cellule squamose della testa e del collo
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Docetaxel
- Oxaliplatino
Altri numeri di identificazione dello studio
- 7H-03-1
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .