Metastatik Kolorektal Kanserli Hastalarda Kemoterapi ve Bevacizumab ile Birinci Basamak Tedavi Sırasında Nötropeniyi Önlemede G-CSF

Sade dilde özet

Bu çalışma, metastatik kolorektal kanser (metastatic colorectal cancer) yani yayılmış kalın bağırsak kanseri olan hastalarda kemoterapi ve bevacizumab tedavisi sırasında görülen nötropeninin (bağışıklık hücresi düşüklüğü) filgrastim (G-CSF) ile önlenip önlenemeyeceğini incelemektedir. Çalışmaya, UGT1A1*28 geni açısından homozigot (7/7) genotipe sahip, ölçülebilir hastalığı olan hastalar katılabilmiştir. Çalışma 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

Federation Francophone de Cancerologie Digestive

Müdahale

bevacizumab, filgrastim, fluorouracil, irinotecan hydrochloride, leucovorin calcium

Başlangıç

01.11.2007

Tahmini bitiş

01.12.2013

İlgili genler

Uygunluk kriterleri

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

DISEASE CHARACTERISTICS:

Inclusion criteria:

* Histologically confirmed adenocarcinoma of the colon or rectum

  * Metastatic disease
  * Not surgically curable
* Homozygous for allele UGT1A1\*28, the promoter of the gene coding for UGT1A1 (genotype 7/7)
* Measurable and/or evaluable disease

Exclusion criteria:

* Original tumor not removed
* CNS metastases
* Secondary localized cerebral tumors

PATIENT CHARACTERISTICS:

Inclusion criteria:

* WHO performance status 0-2
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Creatinine \> 1.5 mg/dL
* Total bilirubin ≤ 1.5 times normal
* Alkaline phosphatase ≤ 2.5 times normal (5 times normal if liver involvement)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients of must use effective contraception

Exclusion criteria:

* Progressive gastroduodenal ulcer, prior hemorrhagic ulcer, or perforation in the past 6 months
* Enteropathy or chronic diarrhea
* Chronic inflammatory intestinal disease
* Intestinal obstruction
* Active cardiac disease including any of the following:

  * Uncontrolled hypertension
  * Myocardial infarction in the past 12 months
  * Serious angina
  * NYHA class II-IV congestive heart failure
  * Severe arrhythmia (even if treated)
  * Peripheral vascular disease ≥ grade 2
* Unhealed wound, ulcer, or severe bone fracture
* Bleeding disorder or coagulopathy
* Severe uncontrolled infection or medical condition
* Proteinuria \> 500 mg/24 hours
* Other malignancy within the past 5 years except basal cell skin cancer or curatively treated carcinoma in situ of the cervix
* Known dihydropyrimidine dehydrogenase deficiency
* Severe traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

* At least 2 weeks since prior radiotherapy

Exclusion criteria:

* Prior chemotherapy for metastatic disease except adjuvant chemotherapy completed \> 6 months ago
* Prior irinotecan hydrochloride or bevacizumab
* Major surgery or biopsy within the past 4 weeks
* Major surgery planned
* Puncture in the past week
* Chronic aspirin (\> 325 mg/day) or NSAIDs
* Concurrent antifungal azoles (e.g., ketoconazole, fluconazole, itraconazole)
* Concurrent phenytoin (as in yellow fever vaccine)
* Concurrent Hypericum perforatum (St. John's wort)
* Oral or parenteral coagulant in the past 10 days and during study therapy

  * Warfarin allowed provided INR \< 1.5