Kolorektal Kanser Hastalarında Cetuximab ve FOLFOX4 Kombinasyon Tedavisinin Güvenlilik ve Etkinlik Çalışması

Sade dilde özet

Bu çalışma, karaciğere yayılmış (metastaz) ve ameliyatla çıkarılamayan kolorektal kanser (colorectal cancer) hastalarında cetuximab ile FOLFOX-4 kemoterapisinin birlikte kullanımını, tek başına FOLFOX-4 ile karşılaştırarak incelemektedir. Çalışmaya, daha önce ileri hastalık için kemoterapi almamış 75 yaş altı hastalar alınmıştır. Araştırma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Müdahale

FOLFOX-4+cetuximab, FOLFOX-4

Başlangıç

01.02.2005

Tahmini bitiş

01.02.2009

Ülkeler

Spain

İlgili genler

Merkezler

• Madrid, Spain

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Written informed consent.
* Men and women \< 75 years
* Histologically confirmed diagnosis of CRC
* Metastatic colorectal carcinoma with exclusive non-resectable hepatic metastases, due to fulfillment of one of the following criteria:

  1. Number of hepatic metastases \> or= 4;
  2. Size of one or more hepatic metastases \> 5 cm diameter;
  3. Vascular involvement and/or poor site that prevent complete resection of hepatic disease and/or require resection with the remaining liver mass less than 25-30% of functional liver.
* Presence of at least one lesion detectable by two-dimensional measurement.
* Karnofsky functional status \>or=70% at the time of enrollment in study
* Life expectancy greater than 3 months.
* Patients must not have received chemotherapy for advanced/metastatic disease.
* Patients with the following characteristics will be enrolled:

  1. Recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with disease-free period \> 6 months following conclusion of treatment.
  2. Recurrence after surgical and/or radiotherapy treatment without adjuvant systemic treatment.
  3. De novo diagnosis of disease.
* Proper liver function, defined by aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) \< or = 2.5 x ULN (\< or = 5 x ULN if there are hepatic metastases) and total bilirubin count \< 1.5 x ULN.
* Proper kidney function, defined as serum creatinine \< 1.5 x ULN.
* Proper hematological function, defined as neutrophil count \> or = 1.5 x 109/l , platelets \> or = 100 X 109/l and hemoglobin \> or = 9 g/dl.
* Effective birth control method for men as well as women if there is possibility of pregnancy

Exclusion Criteria:

* Documented or suspected cerebral and/or leptomeningeal metastases.
* Metastasis in any other non-hepatic site, including extrahepatic lymph node metastases.
* Surgery (excluding biopsy for diagnosis) and/or radiotherapy within 4 weeks prior to enrollment in the study.
* Participation in another clinical trial with medication in the past 30 days.
* Chronic, concomitant administration of systemic immunotherapy, chemotherapy, hormone therapy or any other investigational drug.
* Prior malignant tumour in past 5 years, except history of basal cell skin carcinoma or pre-invasive cervical carcinoma.
* Any investigational drug during the 4 weeks prior to enrolment.
* Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment.
* Prior participation in study in which treatment with cetuximab can be assigned (whether or not treatment with cetuximab is received)
* Acute or subacute intestinal occlusion or history of inflammatory intestinal disease.
* Evidence of grade 3 or 4 allergic reaction to any of the treatment components.
* Clinically relevant peripheral neuropathy.
* Clinically relevant myocardial disease or history of myocardial infarction in the past 12 months.
* Known abuse of alcohol / drugs, Legal incapacity or limited legal capacity.
* Any medical or psychological disorder which, in the opinion of the investigator, does not allow the patient to conclude the study or sign the informed consent.
* Pregnant or nursing woman