Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer With Liver Metastases or Lung Metastases That Are Potentially Removable by Surgery

6 agosto 2009 aggiornato da: Centre Hospitalier Universitaire Vaudois

Oxaliplatin-CPT-11-5-FU-Leucovarin + Bevacizumab and Cetuximab (OCFL-BC) as a Combination Regimen for Systemic Treatment of Advanced Colorectal Carcinoma With Potentially Resectable Liver and/or Lung Metastases. A Phase II Study

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and 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. Giving combination chemotherapy together with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with monoclonal antibody therapy works in treating patients with advanced colorectal cancer with liver metastases or lung metastases that are potentially removable by surgery.

Panoramica dello studio

Descrizione dettagliata

OBJECTIVES:

Primary

  • To determine the pathological complete response (CR) rate in resected patients assessed on lesions of less than or equal to 30 mm in size.

Secondary

  • To determine the clinical CR rate in all patients.
  • To determine toxicity and tolerability of this regimen (pre- and postoperative toxicity).
  • To evaluate perioperative safety in these patients.
  • To determine disease-free survival (time to progression in unresected patients) and overall survival of the whole study population.
  • To determine resectability in these patients.
  • To evaluate markers that predict the occurrence of a pathological CR or a non-response in pathological material (resected liver metastasis) and biological material collected from these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, oxaliplatin IV over 2 hours on days 1 and 15, irinotecan hydrochloride IV over 30 minutes on days 8 and 22, fluorouracil IV over 24 hours on days 1, 8, 15, and 22, leucovorin calcium IV on days 1, 8, 15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 5 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients who are able to undergo liver resection receive bevacizumab on day 1 only of course 3 and undergo liver resection 3 weeks after chemotherapy. Beginning 4 weeks after liver resection, patients receive 2 additional courses of chemotherapy as adjuvant therapy.

Patients undergo tumor tissue and blood sample collection periodically for biological studies. Samples are analyzed for markers that predict the occurrence of a complete pathological response (pCR) or a non-response.

After completion of study treatment, patients are followed every 3 months for the first 2 years and then every 6 months thereafter.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

35

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

      • Chur, Svizzera, CH-7000
        • Kantonspital Aarau
      • Geneva, Svizzera, CH-1211
        • Hôpital Cantonal Universitaire de Genève
      • Lausanne, Svizzera, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • Sion, Svizzera, CH -1951
        • Hopital Regional de Sion-Herens-Conthey

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

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Histologically confirmed metastatic colorectal adenocarcinoma
  • Bidimensionally measurable metastatic disease limited to the liver and considered curatively resectable after response to systemic therapy as assessed by a surgical board

    • Additional metastatic disease to the lungs consisting of no more than 3 potentially resectable lesions allowed
    • Must have at least one lesion of 30 mm or less

Exclusion criteria:

  • History or evidence upon physical examination of CNS disease unless adequately treated (e.g., uncontrolled seizure with standard medical therapy or history of stroke)

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Performance status ≤ 1
  • Life expectancy > 12 weeks
  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine 1.25 x upper limit of normal (ULN)
  • Bilirubin 1.25 x ULN (1.5 x ULN if liver metastasis)
  • AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastasis)
  • Woman and men of childbearing age must use adequate contraception

Exclusion criteria:

  • Pregnancy (positive serum pregnancy test) or lactation
  • Chronic diarrhea ≥ grade 2
  • Other serious illness or medical condition including any of the following:

    • Unstable cardiac disease requiring treatment
    • Congestive heart failure or angina pectoris even if medically controlled
    • Significant arrhythmias
    • History of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent
    • Active uncontrolled infection
    • Severe hypercalcemia
    • Other serious underlying medical condition that could impair the ability of the patient to participate in the study
    • Neuropathy > grade 1 of any etiology
  • Known DPD deficiency
  • Known severe polyneuropathy
  • Known allergy to Chinese hamster ovary cell proteins, other recombinant human or humanized antibodies, any excipients of bevacizumab formulation, or any other study drugs
  • Chronic inflammatory bowel disease
  • Acute or subacute intestinal occlusion
  • History of previous arterial thromboembolism
  • Uncontrolled hypertension
  • Evidence of bleeding diathesis or coagulopathy
  • Serious nonhealing wound, ulcer, or bone fracture
  • History of tumor other than basocellular carcinoma of the skin
  • Peripheral neuropathy > grade 1 of any origin (e.g., alcohol)
  • Significant traumatic injury within 28 days prior to study treatment

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

  • No prior chemotherapy for metastatic disease

    • Prior adjuvant chemotherapy permitted if interval since last treatment administration and recurrence is > 6 months
  • Major surgical procedure or open biopsy within 28 days prior to study treatment or anticipation of the need for major surgical procedure during the course of the study
  • Treatment in a clinical trial within 30 days prior to study entry
  • Concurrent treatment with other experimental drugs or other anticancer therapy
  • Current or recent use (within 10 days prior to study treatment) of full-dose oral or parenteral anticoagulants for therapeutic purposes
  • Chronic daily treatment with aspirin (> 325 mg/day)

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
  • Mascheramento: Nessuno (etichetta aperta)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Pathological complete response rate of lesions of less than or equal to 30 mm in size assessed by pathologic examination in resected specimens

Misure di risultato secondarie

Misura del risultato
Response as assessed by NCIC criteria
Toxicity as assessed by NCIC criteria

Collaboratori e investigatori

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

Investigatori

  • Cattedra di studio: Arnaud Roth, MD, Hôpital Cantonal Universitaire de Genève

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 giugno 2007

Date di iscrizione allo studio

Primo inviato

6 agosto 2007

Primo inviato che soddisfa i criteri di controllo qualità

6 agosto 2007

Primo Inserito (Stima)

8 agosto 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

7 agosto 2009

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 agosto 2009

Ultimo verificato

1 giugno 2009

Maggiori informazioni

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 .

Prove cliniche su Cancro colorettale

Prove cliniche su fluorouracile

Sottoscrivi