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Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer

16 marzo 2016 aggiornato da: Hoffmann-La Roche

A Phase II Study of Oral Xeloda (Capecitabine) in Combination With Intravenous Irinotecan for Patients With Locally Advanced and/or Metastatic Colorectal Cancer

PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

Primary:

  • Determine the overall objective response rate in patients with locally advanced, locally recurrent, or metastatic colorectal cancer treated with capecitabine and irinotecan.

Secondary:

  • Determine the time to treatment failure, time to overall response, duration of overall response, duration of overall complete response, and time to progression in patients treated with this regimen.
  • Determine the 1-year survival and overall survival of patients treated with this regimen.
  • Determine the toxicity and safety profile of this regimen in these patients.
  • Determine the feasibility of predicting responses to this regimen by the molecular profile of tumor tissue in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 2-15 and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients maintaining a response or stable disease after 12 courses may continue treatment at the discretion of the investigator.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 9 months.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

67

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

  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • California
      • Loma Linda, California, Stati Uniti, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
    • Connecticut
      • Norwich, Connecticut, Stati Uniti, 06360
        • Eastern Connecticut Hematology and Oncology Associates
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20007
        • Lombardi Cancer Center at Georgetown University Medical Center
      • Washington, District of Columbia, Stati Uniti, 20037
        • George Washington University Medical Center
    • Florida
      • Jacksonville, Florida, Stati Uniti, 32209
        • University of Florida Health Science Center - Jacksonville
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40536-0084
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Missouri
      • Saint Louis, Missouri, Stati Uniti, 63110-0250
        • St. Louis University Hospital Cancer Center
    • New York
      • Bronx, New York, Stati Uniti, 10451
        • Lincoln Medical and Mental Health Center
      • Brooklyn, New York, Stati Uniti, 11235
        • HemOnCare, P.C.
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Stati Uniti, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29403
        • Charleston Hematology-Oncology, P.A.
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22908
        • Cancer Center at the University of Virginia
    • Washington
      • Seattle, Washington, Stati Uniti, 98104
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Spokane, Washington, Stati Uniti, 99202
        • Rockwood Clinic P.S.
    • West Virginia
      • Morgantown, West Virginia, Stati Uniti, 26506-9300
        • West Virginia University Hospitals

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma

  • At least 1 measurable lesion

    • At least 10 mm by spiral CT scan
    • At least 20 mm by conventional techniques
    • Bone metastases, ascites, or pleural effusions are not considered measurable disease
  • No evidence of CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present or 10 times ULN if bone metastases present)
  • No known Gilbert's disease

Renal:

  • Creatinine no greater than 1.5 times ULN
  • Creatinine clearance at least 50 mL/min

Cardiovascular:

  • No clinically significant cardiac disease
  • No congestive heart failure
  • No symptomatic coronary artery disease
  • No cardiac arrhythmias uncontrolled with medication
  • No myocardial infarction within the past 12 months

Gastrointestinal:

  • Able to swallow tablets
  • No lack of physical integrity of the upper gastrointestinal tract
  • No malabsorption syndrome

Other:

  • No prior unanticipated severe reaction to fluoropyrimidine therapy
  • No hypersensitivity to fluorouracil
  • No history of uncontrolled seizures or CNS disorders
  • No psychological illness or condition that would preclude study entry
  • No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
  • No serious infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 12 months since prior neoadjuvant or adjuvant, active or passive immunotherapy
  • No concurrent active or passive immunotherapy (e.g., 17-1A antibody) for colon cancer
  • No concurrent prophylactic hematopoietic growth factors

Chemotherapy:

  • At least 12 months since prior neoadjuvant or adjuvant cytotoxic chemotherapy
  • No prior chemotherapy for metastatic colorectal cancer
  • No prior therapy with irinotecan or capecitabine
  • No other concurrent cytotoxic agents

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to measurable lesion (newly arising lesions in a previously irradiated area allowed)
  • No concurrent radiotherapy

Surgery:

  • At least 4 weeks since prior major surgery and recovered
  • No prior organ allograft

Other:

  • At least 4 weeks since prior participation in an investigational drug study
  • No other concurrent investigational drugs

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: Cohort 1,Initial Regimen:(Capecitabine + Irinotecan )
Participants will receive capecitabine (Xeloda) 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discretion of the investigator, participants who are responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Droga: Capecitabina
Droga: Irinotecano
Sperimentale: Cohort 2,Amended Regimen:(Capecitabine + Irinotecan)
Participants will receive capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discretion of the investigator, participants who will be responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Droga: Capecitabina
Droga: Irinotecano

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Tumor Response Rate Based on Tumor Measurement as Per Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST 1.0)
Lasso di tempo: Approximately 43 Months
Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as a greater than or equal to (>/=) 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as reference the baseline sum of LD. Participants who did not have a post-baseline tumor measurement were considered non-responders in the assessment of ORR.
Approximately 43 Months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Disease Progression
Lasso di tempo: Approximately 43 Months
Time to disease progression was assessed as the time from start of treatment to the time the participant was first recorded as having disease progression or died due to causes other than disease progression. If a participant never progressed while being followed, he/she was censored at the date of the last tumor assessment or the date of the last dose if no post-baseline tumor measurement was available.
Approximately 43 Months
Time to Treatment Failure
Lasso di tempo: Approximately 43 Months
Time to treatment failure was assessed as the time from start of treatment to the time the participant was withdrawn due to any of the reasons such as adverse events, progressive disease, insufficient therapeutic response, death, failure to return, or refused treatment, did not cooperate or withdrew consent.
Approximately 43 Months
Percentage of Participants With One-year Survival
Lasso di tempo: Up to Month 12
Survival was measured as the time from start of treatment to the date of death or till one year whichever occurred first.
Up to Month 12
Overall Survival
Lasso di tempo: Approximately 43 Months
Overall Survival is defined as the time from start of treatment to the date of death. Participants who did not die were censored at the last date the participant was known to be alive.
Approximately 43 Months
Time To Objective Response
Lasso di tempo: Approximately 43 Months
The time to objective response is defined as the time from start of treatment to the date of first objective response. Participants who never responded during study were censored at the last tumor assessment or the date of last dose, whichever was later, or at the date of death if occurring prior to response.
Approximately 43 Months
Duration of Overall Response
Lasso di tempo: Approximately 43 Months
Duration of overall response was assessed from the time that measurement criteria were first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease was documented. It was analyzed for responders only. Participants without observed progressive disease after an objective response were censored at the date of the last tumor assessment.
Approximately 43 Months
Duration of Overall Complete Response
Lasso di tempo: Approximately 43 Months
The duration of overall complete response was assessed from the time that measurement criteria were met for complete response until the first date that recurrent or progressive disease was objectively documented. Participants without observed progressive disease after an objective complete response were censored at the date of the last tumor assessment.
Approximately 43 Months
Number of Participants With Any Adverse Events, Serious Adverse Events and Deaths
Lasso di tempo: Approximately 43 Months
An adverse event (AEs) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is defined as any event which was fatal (resulted in death), life-threatening (with immediate risk of death), resulted in a new or prolongation of a current hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, considered medically significant by the investigator, required intervention to prevent one or more of the outcomes listed above.
Approximately 43 Months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hoffmann-La Roche

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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 maggio 2001

Completamento primario (Effettivo)

1 dicembre 2004

Completamento dello studio (Effettivo)

1 dicembre 2004

Date di iscrizione allo studio

Primo inviato

10 agosto 2001

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2003

Primo Inserito (Stima)

27 gennaio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

15 aprile 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 marzo 2016

Ultimo verificato

1 febbraio 2005

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ML16323

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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