- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00448838
Cetuximab, Gemcitabine, and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Pilot Study of Gemcitabine, Oxaliplatin, and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.
PURPOSE: This clinical trial is studying how well giving cetuximab together with gemcitabine and oxaliplatin works in treating patients with locally advanced or metastatic pancreatic cancer.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
Primary
- Determine the progression-free survival of patients with locally advanced or metastatic pancreatic cancer treated with cetuximab, gemcitabine hydrochloride, and oxaliplatin.
Secondary
- Determine the complete response and partial response in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
- Determine the duration of response in patients treated with this regimen.
- Determine the survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a nonrandomized, open-label, pilot study.
Patients receive cetuximab IV over 1-2 hours on days 1 and 8, gemcitabine hydrochloride IV over 100 minutes on day 1, and oxaliplatin IV over 2-4 hours on day 2. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Florida
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Miami, Florida, Stati Uniti, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
-
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed pancreatic cancer
- Locally advanced or metastatic disease
No active CNS metastases
- Patients with stable CNS disease, who have undergone radiotherapy within the past 4 weeks and who have been on a stable dose of corticosteroids for > 3 weeks, are eligible
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 mg/dL
- Alkaline phosphatase ≤ 3 times upper limit of normal (ULN) (5 times ULN if known hepatic metastases)
- AST and ALT ≤ 3 times ULN (5 times ULN if known hepatic metastases)
- Creatinine ≤ 1.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 90 days after completion of study treatment
No significant history of uncontrolled cardiac disease, including any of the following:
- Uncontrolled hypertension
- Unstable angina
- Myocardial infarction within the past 6 months
- Uncontrolled congestive heart failure
- Cardiomyopathy with decreased ejection fraction
- No prior severe infusion reaction to a monoclonal antibody
- No active infection or fever ≥ 38.5°C within the past 3 days
- No known hypersensitivity to any components of gemcitabine hydrochloride, oxaliplatin, or to a monoclonal antibody
- No peripheral neuropathy ≥ grade 2
- No known HIV positivity
- No hepatitis B or C infection (active, previously treated, or both)
- No other medical condition, including mental illness or substance abuse, that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy, including surgery
- More than 30 days since prior investigational therapy
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of bone marrow
- More than 30 days since prior chemotherapy
- No prior chemotherapy for metastatic pancreatic cancer
- Prior fluoropyrimidine as a radiosensitizer allowed
- Prior gemcitabine hydrochloride in the adjuvant setting allowed
- No prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway
- No prior allogeneic transplantation
- No other concurrent investigational therapy, chemotherapy, or systemic antineoplastic therapy
- No other concurrent treatment that targets the EGFR
- No other concurrent monoclonal antibody therapy
- No concurrent radiotherapy except for local control of bone pain
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Progression-free survival
Lasso di tempo: The cumulative percentage of intent to treat patients who experience disease progression at 1, 2, 3, 4, 5, and 6 months will be characterized with corresponding 95% confidence intervals
|
The corresponding progression-free survival curve and cumulative risk of progression as a function of time post treatment initiation will be estimated using the Kaplan-Meier method
|
The cumulative percentage of intent to treat patients who experience disease progression at 1, 2, 3, 4, 5, and 6 months will be characterized with corresponding 95% confidence intervals
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Toxicity
Lasso di tempo: Frequency and severity of adverse events according to the NCI CTCAE V 3.0 body system and severity criteria will be described.
|
Frequency and severity of adverse events according to the NCI CTCAE V 3.0 body system and severity criteria will be described.
|
|
Response rate (complete response and partial response)
Lasso di tempo: After every 4th cycle; End of Treatment and Follow-up
|
The response rate will be determined by the RECIST criteria.
After every 4th cycle; End of Treatment and Follow-up
|
After every 4th cycle; End of Treatment and Follow-up
|
Duration of response
Lasso di tempo: The time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented
|
the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started
|
The time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented
|
Overall survival
Lasso di tempo: Overall survival will also be estimated using the product-limit method of Kaplan-Meier.
|
Overall survival will also be estimated using the product-limit method of Kaplan-Meier.
|
Overall survival will also be estimated using the product-limit method of Kaplan-Meier.
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Time to progression
Lasso di tempo: The time from the start of the treatment until the criteria for disease progression are met
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The time from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started (also referred to in the RECIST criteria as duration of stable disease).
|
The time from the start of the treatment until the criteria for disease progression are met
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Neoplasie
- Neoplasie per sede
- Malattie del sistema endocrino
- Neoplasie dell'apparato digerente
- Neoplasie delle ghiandole endocrine
- Malattie pancreatiche
- Neoplasie pancreatiche
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antinfettivi
- Agenti antivirali
- Inibitori enzimatici
- Antimetaboliti, Antineoplastici
- Antimetaboliti
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti antineoplastici, immunologici
- Gemcitabina
- Oxaliplatino
- Cetuximab
Altri numeri di identificazione dello studio
- 20057548
- SCCC-2005141 (Altro identificatore: University of Miami Sylvester Comprehensive Cancer Center)
- WIRB-20052717 (Altro identificatore: Western Insitutional Review Board)
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 .
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